Clinical Trials for Sarcoma

KEYMAKER-U01 Substudy 01J: A Randomized Phase 2 Umbrella Study With Rolling Arms of Investigational Agents for First-line Treatment of Participants With Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With KRAS G12C 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

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.

TrialFetch AI summary: Enrolls adults with previously untreated advanced/metastatic nonsquamous NSCLC harboring a KRAS G12C mutation (tumor tissue or ctDNA), requiring available archival/new non-irradiated tumor tissue and excluding prior KRAS-targeted therapy or active CNS disease. Randomizes first-line treatment to pembrolizumab + carboplatin/pemetrexed vs pembrolizumab plus MK-1084 (selective covalent KRAS G12C-GDP inhibitor) vs pembrolizumab + MK-1084 + cetuximab (EGFR antibody).

ClinicalTrials.gov ID: NCT07252739

An Open-Label, Multicenter, Phase 2 Study With Safety Lead-In of Intratumoral Vusolimogene Oderparepvec (VO) in Combination With Pembrolizumab in Patients With Angiosarcoma

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.

TrialFetch AI summary: Enrolls adults with locally advanced/unresectable or metastatic, RECIST-measurable cutaneous angiosarcoma with at least one injectable lesion and ECOG 0–1 who have progressed on prior taxane/anthracycline chemotherapy and on an immunotherapy-based regimen within 6 months. Patients receive intratumoral vusolimogene oderparepvec (RP1), an HSV-1–derived oncolytic immunotherapy engineered to express GM-CSF and a fusogenic glycoprotein to enhance immunogenic tumor cell death/antigen presentation, in combination with pembrolizumab (PD-1 blockade).

ClinicalTrials.gov ID: NCT06898970

A Phase III Study of AL3818 (Anlotinib, Catequentinib) Hydrochloride Monotherapy in Subjects With Metastatic or Advanced Alveolar Soft Part Sarcoma, Leiomyosarcoma and Synovial 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

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.

TrialFetch AI summary: Adults (≥18) with unresectable locally advanced or metastatic alveolar soft part sarcoma (currently enrolling; prior systemic therapy allowed except prior cediranib) receive oral anlotinib (AL3818/catequentinib), a multitarget anti-angiogenic TKI (VEGFR1–3/FGFR1–4/PDGFRα/β/c-Kit), 12 mg daily on a 14-days-on/7-days-off schedule until progression/toxicity. Closed cohorts previously randomized patients with progressed leiomyosarcoma or synovial sarcoma to anlotinib versus dacarbazine (with crossover to anlotinib at progression) or anlotinib versus placebo in leiomyosarcoma.

ClinicalTrials.gov ID: NCT03016819

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

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.

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.

TrialFetch 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

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.

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.

TrialFetch 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

A Dose Escalation Study Using Eflornithine (DFMO) and AMXT 1501 Followed by a Randomized Controlled Trial of DFMO With or Without AMXT 1501 for Neuroblastoma, CNS Tumors, and Sarcomas

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.

TrialFetch AI summary: Pediatric, adolescent, and young adult patients with relapsed/refractory neuroblastoma (randomized to DFMO with or without AMXT 1501) and single-arm cohorts for relapsed/refractory ETMR/ATRT, newly diagnosed DIPG post-RT, and relapsed/refractory Ewing sarcoma or osteosarcoma receive oral eflornithine (DFMO) with AMXT 1501. AMXT 1501 inhibits polyamine transport and DFMO irreversibly inhibits ornithine decarboxylase, aiming to block both polyamine uptake and synthesis.

ClinicalTrials.gov ID: NCT06465199

A Phase I Trial of Zanzalintinib Combined With Eribulin in Advanced Liposarcoma and Leiomyosarcoma

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.

TrialFetch AI summary: Adults with unresectable/metastatic leiomyosarcoma or adipocytic sarcoma (excluding pure WD LPS and low‑grade LMS), ECOG 0–1, after 1–4 prior lines receive eribulin (D1,8 q21d) plus oral zanzalintinib (XL092), a multi‑target TKI of VEGFR2/MET/TAM kinases aimed at anti‑angiogenic and immunomodulatory effects. Allows treated/stable brain mets; key exclusions include significant CV disease, bleeding risk, GI perforation risk, moderate–severe hepatic impairment, and prior zanzalintinib.

ClinicalTrials.gov ID: NCT06957431

A Phase 1/2, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, and Preliminary Anti-tumor Activity of TNG462 as a Single Agent and in Combination in Patients With MTAP-deleted Advanced or Metastatic Solid Tumors

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.

TrialFetch AI summary: Adults with advanced or metastatic solid tumors harboring homozygous MTAP deletions who have progressed on standard therapy are eligible for treatment with TNG462, a selective PRMT5 inhibitor targeting MTAP-deleted tumor cells, either as monotherapy or in combination with pembrolizumab.

ClinicalTrials.gov ID: NCT05732831

An Open-label, Multicenter, Dose Escalation and Expansion Phase 1/2 Study to Evaluate the Safety, Tolerability and Pharmacokinetics, and Anti-tumor Activity of GI-102, a CD80-IgG4 Fc-IL-2v Bispecific Fusion Protein, As a Single Agent and in Combination with Conventional Anti-cancer Drugs, Pembrolizumab or Trastuzumab Deruxtecan(T-DXd) in Patients with Advanced or Metastatic Solid Tumors (KEYNOTE-G08)

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.

TrialFetch AI summary: This trial enrolls adults with advanced or metastatic solid tumors (ECOG 0-1, no active CNS metastases) to receive GI-102, a bispecific CD80–IL-2 variant fusion protein designed to selectively activate CD8+ T and NK cells, as monotherapy or combined with standard regimens, including pembrolizumab and trastuzumab deruxtecan (for HER2+ disease).

ClinicalTrials.gov ID: NCT05824975

MC220806: Phase I Study Evaluating the Efficacy of CSF1R and TAM Receptor or Inhibition in Hematologic Malignancies With Q702, a Small Molecular Inhibitor

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.

TrialFetch AI summary: Adults with relapsed/refractory histiocytic neoplasms (including ECD, LCH, histiocytic sarcoma, Rosai-Dorfman) lacking actionable BRAF/MAP2K alterations or post–BRAF/MEK, plus high‑risk MDS/CMML/MF post‑standard therapy, and multiple relapsed/refractory lymphomas/CLL after ≥2 prior lines, receive oral Q702 (adrixetinib), a TAM kinase (AXL/MERTK) and CSF1R inhibitor given week-on/week-off. The trial assesses safety, RP2D, and preliminary efficacy across disease-specific cohorts.

ClinicalTrials.gov ID: NCT06712810