Clinical Trials for Sarcoma

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

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 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

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

DFMO Maintenance for Patients With Relapsed/Refractory Ewing Sarcoma or Osteosarcoma

Low burden on patient

The trial has a low burden on patients. An example would be a trial testing an oral drug, with scans every 12 weeks which would be similar to standard of care.

TrialFetch AI summary: Single-arm maintenance trial for children and young adults (<40) with relapsed/refractory Ewing sarcoma or osteosarcoma who are now NED after completing relapse therapy, ECOG 0–2, with adequate organ function. Participants receive oral DFMO (eflornithine), an irreversible ornithine decarboxylase inhibitor that depletes polyamines, given twice daily in 28‑day cycles for up to 2 years to delay recurrence.

ClinicalTrials.gov ID: NCT06892678

A Phase 1 Study of APG-1252 (Pelcitoclax) and Cobimetinib in Recurrent Ovarian and Endometrial Cancers

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 recurrent epithelial ovarian/fallopian tube/primary peritoneal or endometrial cancers after ≥1 platinum regimen (ovarian must be platinum‑resistant; prior MEK inhibitor required for low‑grade serous; MSI‑H/dMMR endometrial requires prior PD‑1/PD‑L1 or ineligibility) receive weekly IV pelcitoclax (dual BCL‑2/BCL‑xL inhibitor prodrug with preferential BCL‑xL activity) plus oral cobimetinib (MEK inhibitor) on days 1–21 of 28‑day cycles. Key exclusions include prior BCL inhibitor exposure and strong CYP3A4 modulators; treated/stable brain metastases are allowed.

ClinicalTrials.gov ID: NCT05691504

A Pilot Study of BTX-A51 in Patients With Metastatic and/or Recurrent Liposarcomas Characterized by MDM2 Amplifications, Myxoid Liposarcoma, and CIC-Rearranged Sarcoma

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 metastatic/recurrent liposarcoma (WD/DD with MDM2 amplification or myxoid subtype) or CIC-rearranged sarcoma receive oral BTX-A51 three times weekly; BTX-A51 is an investigational multikinase inhibitor (targets CK1α and CDK7/CDK9) intended to stabilize p53 by suppressing MDM2 and downregulate oncogenic transcription (e.g., MYC, MCL1). Two fixed dose levels (21 mg or 30 mg) are explored with treatment until progression or unacceptable toxicity.

ClinicalTrials.gov ID: NCT06414434

A Phase 1, Multicenter, Open-label, 2-stage, Single-arm Study to Evaluate the Safety and Tolerability of an Autologous Tumor-infiltrating Lymphocytes (TIL) Regimen and Preliminary Antitumor Activity of TIL in Pediatric, Adolescent, and Young Adult Participants With Relapsed or Refractory 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: Single-arm TIL therapy (lifileucel-based autologous tumor-infiltrating lymphocytes expanded ex vivo with IL-2) for children, adolescents, and young adults (≤21 years) with relapsed/refractory solid tumors lacking effective options, including sarcomas, primary CNS tumors, and melanoma. Patients undergo tumor resection for TIL manufacture, nonmyeloablative lymphodepletion, then a single TIL infusion with supportive care (typically IL-2); outcomes include safety and preliminary antitumor activity.

ClinicalTrials.gov ID: NCT06566092