Clinical Trials for Sarcoma

A Phase 3, Randomized, Double-blind, Multicenter Study of MK-1084 in Combination With Pembrolizumab Compared With Pembrolizumab Plus Placebo as Firstline Treatment of Participants With KRAS G12C-Mutant, Metastatic NSCLC With PD-L1 TPS ≥50%

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

HealthScout AI summary: This trial enrolls adults with newly diagnosed, metastatic KRAS G12C-mutant NSCLC and high PD-L1 expression (TPS ≥50%), randomizing them to pembrolizumab plus either MK-1084—a selective KRAS G12C inhibitor—or placebo as first-line treatment. Key exclusions include prior systemic therapy for metastatic disease, active CNS disease, and certain comorbidities.

ClinicalTrials.gov ID: NCT06345729

A Phase 2 Open-label Basket Study to Evaluate the Efficacy and Safety of Orally Administered Reversible Tyrosine Kinase Inhibitor BAY 2927088 in Participants With Metastatic or Unresectable Solid Tumors With HER2-activating Mutations

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

HealthScout AI summary: This trial enrolls adults with metastatic or unresectable solid tumors (excluding NSCLC) harboring activating HER2 mutations, who have progressed on standard therapy or have no satisfactory alternatives. Patients receive BAY2927088, an oral reversible tyrosine kinase inhibitor targeting mutant HER2 and EGFR.

ClinicalTrials.gov ID: NCT06760819

A Single-Arm, Open-label Phase II Trial Testing the Activity of XL092 (Zanzalintinib) in Patients With Advanced Leiomyosarcoma

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

HealthScout AI summary: Adults with metastatic or unresectable leiomyosarcoma after at least two prior systemic regimens (≤2 prior TKIs), ECOG 0–1, receive oral zanzalintinib (XL092), a multi-kinase inhibitor of VEGFR2, MET, and TAM (TYRO3/AXL/MER), given continuously in 14‑day cycles until progression/toxicity. Key exclusions include prior XL092, significant cardiovascular/bleeding risk, unstable CNS disease, and concurrent oral anticoagulants.

ClinicalTrials.gov ID: NCT06571734

A Phase II Trial of Bezuclastinib in Combination with Sunitinib in Patients with GIST Who Progressed on Sunitinib Monotherapy

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

HealthScout AI summary: Adults with unresectable/metastatic KIT-mutant GIST (primarily KIT exon 11 or 9) who progressed on or were intolerant to imatinib and have documented progression on sunitinib receive bezuclastinib 600 mg daily added to sunitinib 37.5 mg daily. Bezuclastinib is a selective KIT TKI with activity against activation-loop and other KIT mutations; trial assesses antitumor activity and safety of the combination.

ClinicalTrials.gov ID: NCT06208748

ADI-PEG 20 or Placebo Plus Gemcitabine and Docetaxel in Previously Treated Subjects With Leiomyosarcoma (ARGSARC): A Randomized, Double Blind, Multi-Center Phase 3 Trial

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

HealthScout AI summary: Adults with advanced or metastatic grade 2–3 leiomyosarcoma (uterine or non‑uterine) after 1–2 prior systemic regimens including doxorubicin, ECOG 0–1, receive gemcitabine/docetaxel plus either ADI‑PEG 20 or placebo. ADI‑PEG 20 (pegargiminase) is a pegylated arginine deiminase that depletes extracellular arginine to target ASS1‑deficient, arginine‑auxotrophic tumors.

ClinicalTrials.gov ID: NCT05712694

A Phase IIa Open Label Study Evaluating the Preliminary Efficacy of Intratumoural Tigilanol Tiglate in Advanced and/or Metastatic Soft Tissue Sarcoma of the Extremities and Body Wall.

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

HealthScout AI summary: Adults with advanced or metastatic soft tissue sarcoma of the extremities/body wall/scalp with at least one palpable or ultrasound‑guided injectable lesion receive intratumoural tigilanol tiglate (EBC‑46), a plant‑derived protein kinase C modulator that induces rapid vascular disruption and hemorrhagic necrosis for local tumor ablation. Single or multiple injections (up to 3.6 mg/m2) are evaluated for local ablation and systemic disease control, with RECIST responses assessed in Stage 2.

ClinicalTrials.gov ID: NCT05755113

An Open-label, Single-arm, Multicohort, Phase 2 Study to Assess the Efficacy and Safety of Tabelecleucel in Subjects With Epstein-Barr Virus-associated Diseases (EBVision)

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

HealthScout AI summary: Enrolling children and adults with EBV-positive disorders who lack suitable first-line options or have relapsed/refractory disease, including PID/AID-associated EBV+ LPD, CNS-involved EBV+ PTLD, PTLD where rituximab/chemotherapy is inappropriate (including CD20‑negative), and rapidly progressive EBV+ sarcomas. Participants receive tabelecleucel, an allogeneic, partially HLA‑matched EBV‑specific cytotoxic T‑cell therapy targeting EBV antigens (EBNA/LMP), given IV on Days 1, 8, and 15 of 35‑day cycles until response or progression.

ClinicalTrials.gov ID: NCT04554914

A Phase II Study of sEphB4-HSA in Kaposi Sarcoma

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

HealthScout AI summary: Adults with biopsy-confirmed cutaneous Kaposi sarcoma (HIV-positive or -negative; treatment-naïve or previously treated, including refractory) receive IV sEphB4-HSA 10 mg/kg every 2 weeks. sEphB4-HSA is a recombinant EphB4–HSA fusion protein that binds EphrinB2 to inhibit EphB4–EphrinB2 signaling implicated in angiogenesis and tumor survival.

ClinicalTrials.gov ID: NCT03993106

An Adapted Phase 2a/2b, Study to Evaluate the Safety, Tolerability, and Efficacy of AdAPT-001 in Subjects With Refractory Solid Tumors

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

HealthScout AI summary: Adults with refractory/advanced solid tumors (ECOG 0–1) and an injectable lesion—with emphasis on sarcoma and tumors eligible for checkpoint inhibitors—receive intratumoral AdAPT-001, an oncolytic adenovirus expressing a secreted TGF-β trap, alone or combined with an investigator-selected immune checkpoint inhibitor. Treatment is given every 2 weeks via intratumoral injections; key exclusions include uncontrolled infection, active hepatitis/HIV, significant autoimmune disease requiring immunosuppression, and prior therapeutic adenovirus.

ClinicalTrials.gov ID: NCT04673942

An Open-Label, Phase II Efficacy Trial of Doxorubicin in Combination With Dual Checkpoint Blockade Using Zalifrelimab (AGEN1884) or Botensilimab (AGEN1181) With Balstilimab (AGEN2034) for Advanced or Metastatic Soft Tissue Sarcomas

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

HealthScout AI summary: Adults with advanced or metastatic soft tissue sarcoma (multiple histologies; ECOG 0–1) eligible for doxorubicin and without prior anthracycline or checkpoint inhibitor receive doxorubicin plus dual checkpoint blockade. Part 1 uses balstilimab (anti–PD‑1) with zalifrelimab (anti–CTLA‑4); Part 2 explores botensilimab (Fc‑enhanced anti–CTLA‑4) ± balstilimab with doxorubicin.

ClinicalTrials.gov ID: NCT04028063