Trial: A Randomized Trial Assessing Adverse Ev…

Trial Details

Sponsor: AbbVie (industry)

Phase: 3

Start date: Nov. 8, 2024

Planned enrollment: 460

Show Summary from Sponsor

Investigational Drug AI Analysis

Show for: ABBV-400 (telisotuzumab)

ABBV-400 (telisotuzumab adizutecan) is an antibody-drug conjugate (ADC) that consists of telisotuzumab, a c-Met-targeting antibody, conjugated to a novel topoisomerase 1 inhibitor payload via a stable, cleavable linker [1]. The drug is designed to specifically target cells expressing c-Met (MET protein), which is frequently overexpressed in several types of cancer including non-small cell lung cancer (NSCLC), gastroesophageal cancer, and colorectal cancer (CRC). The topoisomerase 1 inhibitor payload works by interrupting DNA replication in cancer cells.

Clinical Trial Results

In a Phase 1 study (NCT05029882) of patients with advanced solid tumors, ABBV-400 has shown promising efficacy across multiple cancer types. In colorectal cancer (n=122), objective response rates of 18% and 24% were observed at doses of 2.4 mg/kg and 3.0 mg/kg respectively, with higher response rates (>35%) in patients with higher c-Met expression [2]. In NSCLC patients with EGFR wild-type disease (n=48), the objective response rate was 43.8% with a clinical benefit rate of 85.4% [3]. The drug has also shown activity in patients with MET-amplified tumors, with a 73% response rate reported in one cohort (n=11).

Safety

The safety profile has been generally manageable across trials. Common treatment-emergent adverse events include hematologic effects such as anemia (52-66%), neutropenia (37-62%), and thrombocytopenia (23-43%), as well as non-hematologic events including nausea (57-60%), fatigue (43-49%), and vomiting (38-39%) [1,3]. Grade 3 or higher adverse events occurred in 63-88% of patients across studies. Interstitial lung disease/pneumonitis has been reported in 6-9% of patients. The 2.4 mg/kg dose appears to have better long-term tolerability than 3.0 mg/kg, with higher relative dose intensity and generally lower adverse event rates [2].

Sources:

[1] Phase 1 Results in Advanced Solid Tumors - Annals of Oncology [2] Latest Phase 1 Results in Colorectal Cancer - ASCO 2024 [3] Phase 1 Results in NSCLC - Annals of Oncology

Last updated: Dec 2024

More Resources

Trial ID: NCT06614192

More trial details at ClinicalTrials.gov

Show News & AI Analysis

HealthScout AI Analysis

Goal: The trial aims to evaluate the efficacy and safety of ABBV-400 monotherapy compared with the standard regimen of trifluridine/tipiracil plus bevacizumab in patients with refractory metastatic colorectal cancer with c-Met overexpression.

Patients: The trial is enrolling adults with refractory metastatic colorectal cancer that overexpresses c-Met, an oncogenic target. Eligible patients must have measurable disease (RECIST v1.1), ECOG 0-1, and life expectancy of at least 12 weeks. Patients must not have prior c-MET-targeted treatments or a history of allergies to study drugs.

Design: The study is a global, phase 3, randomized, open-label, controlled trial with a two-stage design. Stage 1 assesses two dosing regimens of ABBV-400. Stage 2 randomizes participants to either the optimal dose of ABBV-400 or to the standard of care combination of trifluridine/tipiracil plus bevacizumab. Up to 460 participants will be enrolled across multiple countries.

Treatments: ABBV-400 is an antibody-drug conjugate comprising a c-Met targeting antibody linked to a novel topoisomerase 1 inhibitor, specifically designed to target c-Met–overexpressing tumor cells. In phase 1 studies, ABBV-400 demonstrated objective response rates of 18-24% in metastatic colorectal cancer, with higher responses observed in patients with higher c-Met expression. The safety profile includes substantial rates of grade ≥3 hematologic and gastrointestinal adverse events, and interstitial lung disease in a minority of patients. The control arm uses trifluridine/tipiracil plus bevacizumab, a standard regimen in refractory mCRC.

Outcomes: Primary outcomes include objective response rate (by independent central review), overall survival, progression-free survival, and assessment of adverse events, laboratory abnormalities, and ECG/vital sign changes. Secondary outcomes address disease control, duration of response, pharmacokinetics, immunogenicity, and patient-reported outcomes via the EORTC QLQ-C30 quality-of-life instrument.

Burden on patient: The patient burden is moderate to high. As a phase 3 study of an investigational antibody-drug conjugate, participants will have frequent clinic visits for infusions, safety monitoring including laboratory assessments and ECGs, and likely repeated pharmacokinetic and immunogenicity blood draws, especially in Stage 1. Radiographic assessments and patient-reported outcomes will be collected as per protocol, and compared to oral therapies alone, the need for IV infusions and increased monitoring will add to overall burden.

Eligibility

Show Criteria

Sites (50)

Sort by distance to:

Mater Hospital Brisbane /ID# 268360

South Brisbane, Queensland, 4101, Australia

No email / No phone

Status: Recruiting

Rambam Health Care Campus /ID# 267739

Haifa, H_efa, 3525408, Israel

No email / No phone

Status: Recruiting

The Chaim Sheba Medical Center /ID# 267741

Ramat Gan, Tel-Aviv, 5265601, Israel

No email / No phone

Status: Recruiting

Tel Aviv Sourasky Medical Center /ID# 267578

Tel Aviv, Tel-Aviv, 6423906, Israel

No email / No phone

Status: Recruiting

Assuta Medical Center /ID# 267745

Tel Aviv, 6789140, Israel

No email / No phone

Status: Recruiting

Rabin Medical Center /ID# 267740

Petah Tikva, 4941492, Israel

No email / No phone

Status: Recruiting

Hadassah Medical Center-Hebrew University /ID# 267579

Jerusalem, 91120, Israel

No email / No phone

Status: Active, not recruiting

Aichi Cancer Center /ID# 268237

Nagoya-shi, Aichi, 464-8681, Japan

No email / No phone

Status: Recruiting

National Cancer Center Hospital East /ID# 268236

Kashiwa-shi, Chiba, 277-8577, Japan

No email / No phone

Status: Recruiting

The University of Osaka Hospital /ID# 268743

Suita-shi, Osaka, 565-0871, Japan

No email / No phone

Status: Recruiting

Saitama Cancer Center /ID# 268706

Kitaadachi-gun, Saitama, 362-0806, Japan

No email / No phone

Status: Recruiting

National Cancer Center Hospital /ID# 268713

Chuo-Ku, Tokyo, 104-0045, Japan

No email / No phone

Status: Recruiting

Seoul National University Bundang Hospital /ID# 268592

Seongnam-si, Gyeonggido, 13620, Korea, Republic of

No email / No phone

Status: Recruiting

Samsung Medical Center /ID# 268720

Seoul, Seoul Teugbyeolsi, 06351, Korea, Republic of

No email / No phone

Status: Recruiting

Asan Medical Center /ID# 268717

Seoul, Seoul Teugbyeolsi, 05505, Korea, Republic of

No email / No phone

Status: Recruiting

Yonsei University Health System Severance Hospital /ID# 268718

Seoul, Seoul Teugbyeolsi, 03722, Korea, Republic of

No email / No phone

Status: Recruiting

Seoul National University Hospital /ID# 268719

Seoul, Seoul Teugbyeolsi, 03080, Korea, Republic of

No email / No phone

Status: Recruiting

Pan American Center for Oncology Trials /ID# 267888

Rio Piedras, 00935, Puerto Rico

No email / No phone

Status: Recruiting

Kaohsiung Chang Gung Memorial Hospital /ID# 267638

Kaohsiung City, Kaohsiung, 833, Taiwan

No email / No phone

Status: Recruiting

National Taiwan University Hospital /ID# 267627

Taipei City, Taipei, 100, Taiwan

No email / No phone

Status: Recruiting

Linkou Chang Gung Memorial Hospital /ID# 267637

Taoyuan City, 333, Taiwan

No email / No phone

Status: Recruiting

Changhua Christian Hospital /ID# 270464

Changhua City, Changhua County, 50006, Taiwan

No email / No phone

Status: Recruiting

Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 267635

Kaohsiung, 807, Taiwan

No email / No phone

Status: Recruiting

China Medical University Hospital /ID# 267631

Taichung, 404, Taiwan

No email / No phone

Status: Recruiting

Taichung Veterans General Hospital /ID# 270467

Taichung, 407, Taiwan

No email / No phone

Status: Recruiting

National Cheng Kung University Hospital /ID# 270468

Tainan, 704, Taiwan

No email / No phone

Status: Recruiting

Taipei Veterans General Hospital /ID# 267628

Taipei City, 112, Taiwan

No email / No phone

Status: Recruiting

City of Hope National Medical Center /ID# 267875

Duarte, California, 91010, United States

No email / No phone

Status: Recruiting

USC Norris Comprehensive Cancer Center /ID# 268131

Los Angeles, California, 90033, United States

No email / No phone

Status: Recruiting

City of Hope Orange County Lennar Foundation Cancer Center /ID# 270655

Irvine, California, 92618, United States

No email / No phone

Status: Recruiting

Lutheran Medical Center- Cancer Centers of Colorado /ID# 268175

Golden, Colorado, 80401, United States

No email / No phone

Status: Recruiting

Yale New Haven Hospital /ID# 269125

New Haven, Connecticut, 06510, United States

No email / No phone

Status: Recruiting

AdventHealth Orlando /ID# 267970

Orlando, Florida, 32803, United States

No email / No phone

Status: Recruiting

Winship Cancer Institute of Emory University /ID# 266884

Atlanta, Georgia, 30322, United States

No email / No phone

Status: Recruiting

St. Luke's Cancer Institute: Boise /ID# 268095

Boise, Idaho, 83712, United States

No email / No phone

Status: Recruiting

Springfield Clinic /ID# 268666

Springfield, Illinois, 62702-3749, United States

No email / No phone

Status: Recruiting

Hope And Healing Cancer Services /ID# 268541

Hinsdale, Illinois, 60521, United States

No email / No phone

Status: Recruiting

Northwestern University Robert H. Lurie Comprehensive Cancer Center /ID# 268610

Chicago, Illinois, 60611-2927, United States

No email / No phone

Status: Recruiting

Community Cancer Center North /ID# 267965

Indianapolis, Indiana, 46250, United States

No email / No phone

Status: Recruiting

Hattiesburg Clinic /ID# 267860

Hattiesburg, Mississippi, 39401, United States

No email / No phone

Status: Recruiting

Washington University /ID# 267872

Saint Louis, Missouri, 63110, United States

No email / No phone

Status: Recruiting

Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana /ID# 268185

Billings, Montana, 59102, United States

No email / No phone

Status: Recruiting

Rutgers Cancer Institute of New Jersey /ID# 268056

New Brunswick, New Jersey, 08901, United States

No email / No phone

Status: Recruiting

Duke University Medical Center /ID# 267966

Durham, North Carolina, 27710, United States

No email / No phone

Status: Recruiting

University of North Carolina Medical Center /ID# 266879

Chapel Hill, North Carolina, 27514, United States

No email / No phone

Status: Recruiting

Avera Cancer Institute - Sioux Falls /ID# 268074

Sioux Falls, South Dakota, 57105, United States

No email / No phone

Status: Recruiting

West Cancer Center and Research Institute - Germantown /ID# 268619

Germantown, Tennessee, 38138, United States

No email / No phone

Status: Recruiting

The University of Texas MD Anderson Cancer Center /ID# 268098

Houston, Texas, 77030, United States

No email / No phone

Status: Recruiting

Millennium Research & Clinical Development /ID# 268400

Houston, Texas, 77090, United States

No email / No phone

Status: Recruiting

University of Virginia /ID# 268108

Charlottesville, Virginia, 22908, United States

No email / No phone

Status: Recruiting

AndroMETa-CRC-064: An Open Label, Randomized, Controlled, Global Phase 3 Study Comparing ABBV-400 Monotherapy to LONSURF (Trifluridine and Tipiracil) Plus Bevacizumab in Subjects With c-Met Over-Expressed Refractory Metastatic Colorectal Cancer

Trial Details

Show Summary from Sponsor

Investigational Drug AI Analysis

Show for: ABBV-400 (telisotuzumab)

Clinical Trial Results

Safety

Sources:

More Resources

Show News & AI Analysis

Preliminary Efficacy and Safety Data

Trial Significance

Trial Status

Key References

HealthScout AI Analysis

Eligibility

Show Criteria

Sites (50)

Mater Hospital Brisbane /ID# 268360

Rambam Health Care Campus /ID# 267739

The Chaim Sheba Medical Center /ID# 267741

Tel Aviv Sourasky Medical Center /ID# 267578

Assuta Medical Center /ID# 267745

Rabin Medical Center /ID# 267740

Hadassah Medical Center-Hebrew University /ID# 267579

Aichi Cancer Center /ID# 268237

National Cancer Center Hospital East /ID# 268236

The University of Osaka Hospital /ID# 268743

Saitama Cancer Center /ID# 268706

National Cancer Center Hospital /ID# 268713

Seoul National University Bundang Hospital /ID# 268592

Samsung Medical Center /ID# 268720

Asan Medical Center /ID# 268717

Yonsei University Health System Severance Hospital /ID# 268718

Seoul National University Hospital /ID# 268719

Pan American Center for Oncology Trials /ID# 267888

Kaohsiung Chang Gung Memorial Hospital /ID# 267638

National Taiwan University Hospital /ID# 267627

Linkou Chang Gung Memorial Hospital /ID# 267637

Changhua Christian Hospital /ID# 270464

Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 267635

China Medical University Hospital /ID# 267631

Taichung Veterans General Hospital /ID# 270467

National Cheng Kung University Hospital /ID# 270468

Taipei Veterans General Hospital /ID# 267628

City of Hope National Medical Center /ID# 267875

USC Norris Comprehensive Cancer Center /ID# 268131

City of Hope Orange County Lennar Foundation Cancer Center /ID# 270655

Lutheran Medical Center- Cancer Centers of Colorado /ID# 268175

Yale New Haven Hospital /ID# 269125

AdventHealth Orlando /ID# 267970

Winship Cancer Institute of Emory University /ID# 266884

St. Luke's Cancer Institute: Boise /ID# 268095

Springfield Clinic /ID# 268666

Hope And Healing Cancer Services /ID# 268541

Northwestern University Robert H. Lurie Comprehensive Cancer Center /ID# 268610

Community Cancer Center North /ID# 267965

Hattiesburg Clinic /ID# 267860

Washington University /ID# 267872

Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana /ID# 268185

Rutgers Cancer Institute of New Jersey /ID# 268056

Duke University Medical Center /ID# 267966

University of North Carolina Medical Center /ID# 266879

Avera Cancer Institute - Sioux Falls /ID# 268074

West Cancer Center and Research Institute - Germantown /ID# 268619

The University of Texas MD Anderson Cancer Center /ID# 268098

Millennium Research & Clinical Development /ID# 268400

University of Virginia /ID# 268108