Trial: AZD0901 Compared With Investigator's Ch…

Trial Details

Sponsor: AstraZeneca (industry)

Phase: 3

Start date: March 4, 2024

Planned enrollment: 572

Trial ID: NCT06346392

More trial details at ClinicalTrials.gov

Show Summary from Sponsor

Investigational Drug AI Analysis

Show for: AZD0901 (Sonesitatug vedotin, CMG901)

Overview

AZD0901 (sonesitatug vedotin; formerly CMG901) is a Claudin 18.2–targeted antibody–drug conjugate (ADC) being developed by AstraZeneca under a global license from KYM Biosciences (Keymed/Lepu). It is in phase 3 for second- or later-line Claudin 18.2–positive gastric or gastroesophageal junction (GEJ) adenocarcinoma and in additional phase 2 studies across Claudin 18.2–expressing solid tumors. (news.cision.com, ascopost.com, cdek.pharmacy.purdue.edu)

Mechanism of action

Target: Claudin 18.2, a tight-junction protein selectively expressed in subsets of gastric/GEJ and pancreatic cancers. (pmc.ncbi.nlm.nih.gov)
Construct: Humanized anti–Claudin 18.2 monoclonal antibody linked via a cleavable linker to the microtubule inhibitor monomethyl auristatin E (MMAE; “vedotin”). The ADC mediates direct cytotoxicity after internalization and payload release, and also shows Fc-mediated ADCC/CDC and bystander killing in preclinical models. (pmc.ncbi.nlm.nih.gov)

Clinical development

Phase 1 (KYM901; NCT04805307): Multicenter, open-label, single-arm dose escalation/expansion in China in advanced gastric/GEJ cancer and other solid tumors. Results published in The Lancet Oncology (Jan 2025). (thelancet.com)
Phase 3 (CLARITY-Gastric 01; NCT06346392): Global, randomized study of AZD0901 vs investigator’s choice in 2L+ Claudin 18.2–positive gastric/GEJ adenocarcinoma; dual primary endpoints PFS (ITT) and OS (≥3L). Recruiting since March 4, 2024. (cdek.pharmacy.purdue.edu, ascopubs.org)
Additional studies:
CLARITY-PanTumor01 (D9800C00001): Phase 2 platform including AZD0901 monotherapy and combinations; substudy in first-line pancreatic ductal adenocarcinoma and a substudy in biliary tract cancer. (astrazenecaclinicaltrials.com)
GEMINI-Gastric (NCT05702229): Phase 2 platform testing AZD0901 in combination with bispecific checkpoint inhibitors plus fluoropyrimidine-based chemotherapy in first-line metastatic gastric/GEJ cancer. (ascopubs.org, astrazenecaclinicaltrials.com)
GEMINI-PeriOp GC (NCT07069712): Phase 2 perioperative platform including an AZD0901-containing arm in resectable gastroesophageal adenocarcinoma. (astrazenecaclinicaltrials.com)

Efficacy

Phase 1 KYM901 (gastric/GEJ cohorts; 2.2–3.0 mg/kg Q3W):
Confirmed objective response rate (cORR) 28% in the full analysis set (32/113), and 29% (32/109) in the efficacy analysis set; median duration of response 7.9 months (95% CI 5.3–10.0) at median follow-up 9.0 months. (thelancet.com)
Earlier public presentations (ASCO Plenary, Nov 2023) reported cORR ~33% and median PFS 4.8 months, 9‑month OS rate 56% in Claudin 18.2–positive patients. Dose-level subgroup cORRs ranged 24–42% across 2.2–3.0 mg/kg. (onclive.com, ascopost.com)

Note: No randomized efficacy data have been reported yet; phase 3 readouts are pending. (cdek.pharmacy.purdue.edu)

Safety

Phase 1 KYM901:
Dose escalation (n=27): any-grade AEs in all patients; most common were vomiting (70%), decreased appetite (59%), proteinuria (59%), anemia (56%); drug-related grade ≥3 AEs in 19%. One DLT (grade 3 pancreatitis) at 2.2 mg/kg; MTD not reached. (thelancet.com)
Dose expansion (gastric/GEJ; n=107): grade ≥3 AEs in 68% (notably decreased neutrophil count 21%, anemia 14%, vomiting 10%); serious AEs in 50%; one treatment-related death (cerebral hemorrhage). Recommended phase 2 dose proposed at 2.2 mg/kg Q3W. (thelancet.com)

Show for: Apatinib (Rivoceranib)

Overview

Apatinib (also known internationally as rivoceranib; YN968D1) is an oral small‑molecule tyrosine kinase inhibitor that primarily targets VEGFR‑2 to inhibit tumor angiogenesis. It is approved in China for advanced gastric cancer and for hepatocellular carcinoma (HCC) in certain settings, while remaining investigational in many regions. Clinical development includes monotherapy and combinations (notably with the PD‑1 inhibitor camrelizumab) across gastric/GEJ cancer, HCC, thyroid cancer, and non–small cell lung cancer (NSCLC). (globenewswire.com, pubmed.ncbi.nlm.nih.gov)

Mechanism of action

Selective VEGFR‑2 inhibitor that blocks receptor autophosphorylation and downstream signaling (RAF/MEK/ERK and PI3K/AKT/mTOR), reducing endothelial proliferation, migration, and vascular permeability; weaker activity reported against RET, c‑KIT, and SRC. (pmc.ncbi.nlm.nih.gov, dovepress.com)

Efficacy

Gastric/gastroesophageal junction adenocarcinoma (post‑chemotherapy) - Phase III, randomized, double‑blind trial in chemotherapy‑refractory disease: apatinib improved median overall survival (OS 6.5 vs 4.7 months; HR 0.71) and progression‑free survival (PFS 2.6 vs 1.8 months) versus placebo. Common grade 3–4 events included hand‑foot syndrome, proteinuria, and hypertension. Phase II data also showed PFS and OS gains vs placebo with partial responses in 9/96 apatinib‑treated patients. (pubmed.ncbi.nlm.nih.gov)

Hepatocellular carcinoma - Camrelizumab + rivoceranib (CARES‑310, randomized international phase III): significantly improved PFS (5.6 vs 3.7 months; HR 0.52) and interim OS (22.1 vs 15.2 months; HR 0.62) versus sorafenib; confirmed ORR 25.4% vs 5.9%. Final OS analysis reported median OS 23.8 months with the combination vs 15.2 months with sorafenib (HR 0.64). (sciencedirect.com, thelancet.com, ascopost.com, elevartherapeutics.com)

Differentiated thyroid cancer (radioiodine‑refractory, RAIR‑DTC) - REALITY randomized phase II trial (apatinib vs placebo): ORR 54.3% vs 2.2%; median PFS 22.2 vs 4.5 months (HR 0.26). Long‑term single‑arm phase II follow‑up reported ORR 80% and median PFS 18.4 months. (pmc.ncbi.nlm.nih.gov, jamanetwork.com, pubmed.ncbi.nlm.nih.gov)

Non–small cell lung cancer (pretreated) - Trials in advanced nonsquamous NSCLC suggest activity: a randomized phase II study reported median PFS 4.7 vs 1.9 months vs placebo (ORR 12.2% vs 0%); single‑arm studies show ORR around 13% with manageable toxicity. (dovepress.com, pubmed.ncbi.nlm.nih.gov)

Regulatory notes - In China, apatinib is approved for gastric cancer and as monotherapy in second‑line advanced HCC; camrelizumab + rivoceranib is approved as first‑line therapy for unresectable HCC. In the United States, rivoceranib remains investigational; an FDA resubmission for camrelizumab + rivoceranib in first‑line unresectable HCC was accepted with a target action date of March 20, 2025. (globenewswire.com, kedglobal.com, elevartherapeutics.com)

Safety

Class‑consistent VEGFR inhibitor adverse events are common: hypertension, proteinuria, and palmar‑plantar erythrodysesthesia/hand‑foot syndrome.
Gastric cancer phase III (monotherapy): most frequent grade 3–4 AEs were hand‑foot syndrome, proteinuria, and hypertension. (pubmed.ncbi.nlm.nih.gov)
HCC CARES‑310 (camrelizumab + rivoceranib): grade ≥3 treatment‑related AEs occurred in 81% vs 52% with sorafenib; most common included hypertension (38%), elevated AST (17%), elevated ALT (13%), and palmar‑plantar erythrodysesthesia (12%). Treatment‑related serious AEs occurred in 24% vs 6%. (ascopost.com)
RAIR‑DTC: common AEs included hand‑foot syndrome, proteinuria, and hypertension; most were manageable with dose modifications. (pmc.ncbi.nlm.nih.gov, pubmed.ncbi.nlm.nih.gov)

HealthScout AI Analysis

Goal: Evaluate whether the Claudin 18.2–targeted antibody–drug conjugate AZD0901 improves progression-free and overall survival versus investigator’s choice of therapy in previously treated, advanced/metastatic gastric or gastroesophageal junction adenocarcinoma expressing CLDN18.2, and concurrently validate the clinical performance of the Ventana CLDN18.2 assay for patient selection.

Patients: Adults (≥18 years) with histologically confirmed unresectable, locally advanced or metastatic gastric, GEJ, or distal esophageal adenocarcinoma, CLDN18.2-positive by archival (≤24 months) or fresh biopsy, after progression on at least one prior line including a fluoropyrimidine and a platinum; ECOG 0–1; adequate organ function; measurable or evaluable disease. Key exclusions include HER2-positive tumors, significant or unstable gastric bleeding/ulcers, active or recent CNS disease, clinically significant corneal disease, persistent ≥grade 2 toxicities from prior therapy, prior ADC with MMAE or non-antibody CLDN18.2-targeted therapies, and recent thromboembolic events.

Design: Global, multi-center, open-label, sponsor-blinded, randomized phase III trial. Approximately 572 participants randomized to AZD0901 or investigator’s choice of standard regimens. Stratification and central blinded independent review are planned for efficacy assessments. The trial also incorporates evaluation of an investigational CLDN18.2 IVD assay.

Treatments: AZD0901 monotherapy (two dose levels were planned; enrollment to the higher dose arm has been closed). AZD0901 (sonesitatug vedotin) is a Claudin 18.2–targeted antibody–drug conjugate that delivers the microtubule inhibitor MMAE via a cleavable linker, with additional Fc-mediated effector functions and potential bystander effect. In phase 1 gastric/GEJ cohorts, confirmed objective response rate was about 28% to 33% with median duration of response near 8 months; grade ≥3 toxicities were mainly hematologic and gastrointestinal, supporting a recommended dose around 2.2 mg/kg every 3 weeks. Comparator: investigator’s choice of regionally accepted therapies, including ramucirumab plus paclitaxel, single-agent paclitaxel, docetaxel, irinotecan, TAS-102, or apatinib (briefly, VEGFR2 inhibitor used in some regions for refractory gastric cancer).

Outcomes: Dual primary endpoints: progression-free survival in all randomized participants and overall survival in the subset treated in third line or later. Key secondary endpoints include overall survival and PFS in all randomized and in 3L+ subgroups, objective response rate and duration of response by BICR per RECIST 1.1, safety and tolerability, pharmacokinetics of AZD0901/total antibody/MMAE, and immunogenicity (ADA prevalence, incidence, and titer).

Burden on patient: Moderate. As a phase III ADC study, participants will undergo standard oncology visits and imaging at intervals typical for metastatic gastric cancer, plus added procedures for ADC characterization: serial blood draws for PK and immunogenicity through at least 30 days after discontinuation, and testing for CLDN18.2 positivity via archival tissue or fresh biopsy if needed. Treatment involves intravenous infusions on a repeating schedule with monitoring for infusion reactions and ADC-related toxicities, which may require more frequent labs early in treatment. Travel and time commitments are greater than for oral regimens but comparable to standard IV chemotherapy comparators; additional PK/ADA sampling increases visit duration and venipunctures.

Eligibility

Show Criteria

Inclusion Criteria:

1. Capable of giving signed informed consent prior to any study procedure.

2. Participant must be at least 18 years or the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the ICF.

3. Histologically confirmed unresectable, locally advanced or metastatic adenocarcinoma of gastric, GEJ, or distal esophagus (distal third of the esophagus) and the following requirement:

(a) Participants with positive CLDN18.2 expression from archival tumor collected within past 24 months or from a fresh biopsy.

4. Disease progression on or after at least one prior line of treatment (LoT) for advanced or metastatic disease, which included a fluoropyrimidine and a platinum, for advanced or metastatic disease.

5. Must have at least one measurable or evaluable lesion assessed by the Investigator based on RECIST 1.1.

6. ECOG performance status of 0 or 1 with no deterioration over the previous 2 weeks prior to baseline or day of first dosing.

7. Predicted life expectancy of ≥ 12 weeks.

8. Adequate organ and bone marrow function

9. Body weight of ≥ 35 kg.

10. Sex and Contraceptive Requirements

Exclusion Criteria:

1. Participants with known HER2 positive status as defined as IHC 3+ or IHC 2+/ISH + (Cases with HER2: CEP17 ratio ≥ 2 or an average HER2 copy number ≥ 6.0 signals/cell are considered positive by ISH). Participants must undergo local (or have had) HER2 testing by IHC/ISH, and the most recent result of HER2 status will be used to determine the eligibility.

2. Participant has significant or unstable gastric bleeding and/or untreated gastric ulcers.

3. CNS metastases or CNS pathology including: epilepsy, seizures or aphasia within 3 months prior to consent, severe brain injury, dementia, Parkinson's disease, neurodegenerative diseases, cerebellar disease, severe uncontrolled mental illness, psychosis, CNS involvement of autoimmune diseases.

4. Participant has known clinically significant corneal disease (eg, active keratitis or corneal ulcerations).

5. Persistent toxicities (CTCAE Grade ≥ 2) caused by previous anticancer therapy, excluding alopecia. Participants with irreversible toxicity that is not reasonably expected to be exacerbated by study intervention may be included (eg, hearing loss).

6. Prior exposure to any ADC with MMAE payload or any CLDN18.2 targeting treatment other than naked monoclonal antibody (eg, CLDN18.2 targeting CAR-T cell therapy, multi-specific antibody including targeting CLDN18.2, etc).

7. History of thromboembolic events:

1. Participants with venous thromboembolism within the past 6 months prior to randomization: participants with venous port or catheter thrombosis or superficial venous thrombus that do not require treatment or are stable on treatment with anticoagulants are excepted

2. History of arterial thromboembolism within the past 12 months prior to randomization

8. As judged by the Investigator, any evidence of diseases which in the Investigator's opinion, makes it undesirable for the participant to participate in the study or that would jeopardize compliance with the protocol.

Sites (186)

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São Paulo, 05652-900, Brazil

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Ribeirão Preto, 14051-140, Brazil

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Porto Alegre, 91350-200, Brazil

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Vitória, 29043-272, Brazil

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Calgary, Alberta, T2N 4N2, Canada

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North York, Ontario, M2K 1E1, Canada

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London, Ontario, N6C 2R5, Canada

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Barrie, Ontario, L4M 6M2, Canada

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Ottawa, Ontario, K1H 8L6, Canada

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Toronto, Ontario, M5G 2M9, Canada

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Montreal, Quebec, H3G 1A4, Canada

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Montreal, Quebec, H3T 1E2, Canada

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Fuzhou, 350001, China

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Shijiazhuang, 050011, China

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Shenyang, 110042, China

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Shanghai, 200040, China

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Shanghai, 200032, China

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Shanghai, 200025, China

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Qingdao, 266003, China

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Nanjing, 210009, China

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Nanjing, 210008, China

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Luoyang, 471003, China

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Lishui, 323000, China

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Lanzhou, 730000, China

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Jining, 272029, China

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Jinan, 250117, China

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Hefei, 230601, China

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Hefei, 230031, China

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Hefei, 230022, China

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Harbin, 150049, China

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Hangzhou, 310022, China

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Hangzhou, 310020, China

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Guangzhou, 510700, China

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Guangzhou, 510655, China

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Guangzhou, 510120, China

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Guangzhou, 510060, China

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Fuzhou, 350014, China

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Chengdu, 610042, China

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Chengdu, 610000, China

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Changsha, 410013, China

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Changchun, 130021, China

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Beijing, 100210, China

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Zhengzhou, 450003, China

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Yinchuan, 750004, China

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Xi'an, 710061, China

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Wuhan, 430030, China

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Wuhan, 430000, China

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Ürümqi, 830000, China

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Tianjin, 300060, China

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Suzhou, 215004, China

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Besançon, 25030, France

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Brest, 29200, France

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Lille, 59037, France

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Lyon, 69008, France

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Nantes, 44000, France

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Paris, 75571, France

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Poitiers, 86021, France

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Moers, 47441, Germany

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Göttingen, 37075, Germany

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Hamburg, 20246, Germany

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Frankfurt, 60488, Germany

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München, 81377, Germany

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Berlin, 13353, Germany

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Berlin, 10249, Germany

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Dresden, 01067, Germany

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Dresden, 01370, Germany

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Essen, 45136, Germany

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Heilbronn, 74078, Germany

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Marburg, 35043, Germany

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Heidelberg, 69120, Germany

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Mainz, 55131, Germany

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Leipzig, 04103, Germany

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Hong Kong, Hong Kong

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Hong Kong, 150001, Hong Kong

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New Delhi, 110085, India

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Mumbai, 400012, India

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Hyderabad, 500082, India

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Bengaluru, 560027, India

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Ahmedabad, 380015, India

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Milan, 20133, Italy

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Florence, 50134, Italy

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Milan, 20162, Italy

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Modena, 41124, Italy

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Napoli, 80131, Italy

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Padua, 35128, Italy

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Pisa, 56100, Italy

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Vicenza, 36100, Italy

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Tokyo, 104-0045, Japan

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Osaka, 541-8567, Japan

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Ogaki-shi, 503-8502, Japan

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Nagoya, 464-8681, Japan

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Kōtoku, 135-8550, Japan

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Kashiwa, 227-8577, Japan

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Fukuoka, 812-8582, Japan

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Toyoake-shi, 470-1192, Japan

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Yokohama, 241-8515, Japan

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Sunto-gun, 411-8777, Japan

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Warsaw, 04-141, Poland

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Bielsko-Biala, 43-300, Poland

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Gdansk, 80-219, Poland

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Katowice, 40-514, Poland

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Krakow, 31-501, Poland

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Lublin, 20-080, Poland

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Szczecin, 71-730, Poland

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Słupsk, 76-200, Poland

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Tomaszów Mazowiecki, 97-200, Poland

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Warsaw, 02-034, Poland

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Seoul, 06351, South Korea

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Seoul, 06591, South Korea

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Seoul, 05505, South Korea

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Seoul, 03722, South Korea

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Seoul, 03080, South Korea

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Gyeonggi-do, 13620, South Korea

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Barcelona, 08036, Spain

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Madrid, 28034, Spain

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Madrid, 28041, Spain

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Ourense, 32005, Spain

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Santander, 39008, Spain

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Seville, 41013, Spain

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Barcelona, 8035, Spain

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Bern, 3010, Switzerland

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Geneva, 1205, Switzerland

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Lausanne, 1011, Switzerland

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Zurich, 8032, Switzerland

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Kaohsiung City, 00807, Taiwan

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Taoyuan District, 333, Taiwan

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Kaohsiung City, 83301, Taiwan

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Taichung, 40447, Taiwan

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Tainan City, Taiwan

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Taipei, 10002, Taiwan

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Taipei, 112, Taiwan

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Bangkok, 10700, Thailand

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Hat Yai, 90110, Thailand

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Khon Kaen, 40002, Thailand

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Dusit, 10300, Thailand

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Ankara, 06230, Turkey (Türkiye)

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Diyarbakır, 21280, Turkey (Türkiye)

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Erzurum, 25240, Turkey (Türkiye)

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Istanbul, 34098, Turkey (Türkiye)

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Cambridge, CB2 0QQ, United Kingdom

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Taunton, TA1 5DA, United Kingdom

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Oxford, OX3 7LE, United Kingdom

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Manchester, M20 4BX, United Kingdom

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London, SW3 6JJ, United Kingdom

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London, EC1A 7BE, United Kingdom

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Mobile, Alabama, 36604, United States

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Birmingham, Alabama, 35233, United States

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Tucson, Arizona, 85719, United States

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Duarte, California, 91010, United States

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Fullerton, California, 92835, United States

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Irvine, California, 92618, United States

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Los Angeles, California, 90048, United States

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Los Angeles, California, 90089, United States

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Newport Beach, California, 92663, United States

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Santa Rosa, California, 95403, United States

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Status: Withdrawn

Research Site

Washington D.C., District of Columbia, 20007, United States

No email / No phone

Status: Recruiting

Research Site

Fleming Island, Florida, 32003, United States

No email / No phone

Status: Recruiting

Research Site

Hollywood, Florida, 33021, United States

No email / No phone

Status: Recruiting

Research Site

Orlando, Florida, 32804, United States

No email / No phone

Status: Recruiting

Research Site

Marietta, Georgia, 30060, United States

No email / No phone

Status: Recruiting

Research Site

Atlanta, Georgia, 30322, United States

No email / No phone

Status: Withdrawn

Research Site

Honolulu, Hawaii, 96819, United States

No email / No phone

Status: Recruiting

Research Site

Boise, Idaho, 83712, United States

No email / No phone

Status: Recruiting

Research Site

Lexington, Kentucky, 40536, United States

No email / No phone

Status: Recruiting

Research Site

Baltimore, Maryland, 21287, United States

No email / No phone

Status: Withdrawn

Research Site

Boston, Massachusetts, 02114, United States

No email / No phone

Status: Recruiting

Research Site

Ann Arbor, Michigan, 48106, United States

No email / No phone

Status: Recruiting

Research Site

Ann Arbor, Michigan, 48109, United States

No email / No phone

Status: Recruiting

Research Site

St Louis, Missouri, 63128, United States

No email / No phone

Status: Withdrawn

Research Site

Kansas City, Missouri, 64111, United States

No email / No phone

Status: Recruiting

Research Site

St Louis, Missouri, 63110, United States

No email / No phone

Status: Withdrawn

Research Site

New York, New York, 10065, United States

No email / No phone

Status: Recruiting

Research Site

New York, New York, 10032, United States

No email / No phone

Status: Recruiting

Research Site

New York, New York, 10016, United States

No email / No phone

Status: Recruiting

Research Site

Mineola, New York, 11501, United States

No email / No phone

Status: Recruiting

Research Site

Cincinnati, Ohio, 45219, United States

No email / No phone

Status: Withdrawn

Research Site

Portland, Oregon, 97239, United States

No email / No phone

Status: Withdrawn

Research Site

York, Pennsylvania, 17403, United States

No email / No phone

Status: Recruiting

Research Site

Philadelphia, Pennsylvania, 19111, United States

No email / No phone

Status: Recruiting

Research Site

Fredericksburg, Virginia, 22408, United States

No email / No phone

Status: Recruiting

Research Site

Charlottesville, Virginia, 22908, United States

No email / No phone

Status: Recruiting

Research Site

Seattle, Washington, 98109, United States

No email / No phone

Status: Not yet recruiting

Research Site

Olympia, Washington, 98502, United States

No email / No phone

Status: Recruiting

Research Site

Hanoi, 100000, Vietnam

No email / No phone

Status: Recruiting

Research Site

Vinh, 460000, Vietnam

No email / No phone

Status: Recruiting

Research Site

Ho Chi Minh City, 700000, Vietnam

No email / No phone

Status: Recruiting

Trial Details

Show Summary from Sponsor

More details:

Investigational Drug AI Analysis

Show for: AZD0901 (Sonesitatug vedotin, CMG901)

Overview

Mechanism of action

Clinical development

Efficacy

Safety

Further reading

Show for: Apatinib (Rivoceranib)

Overview

Mechanism of action

Efficacy

Safety

Further reading

HealthScout AI Analysis

Eligibility

Show Criteria

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