Clinical Trials for Sarcoma

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.

HealthScout 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

A Phase I Study of In Situ Immunomodulation With CDX-301, Radiotherapy, CDX-1140, and Poly-ICLC in Patients With Unresectable and Metastatic Solid Tumors With Injectable Palpable Disease

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.

HealthScout AI summary: Adult patients with unresectable and metastatic melanoma, cutaneous SCC, BCC, Merkel cell carcinoma, high-grade sarcomas, or HER2-negative breast cancer with palpable, injectable lesions are eligible for this trial evaluating intratumoral CDX-301 (Flt3 ligand), radiotherapy, CDX-1140 (agonistic anti-CD40 antibody), and Poly-ICLC, with additional arms including pembrolizumab (PD-1 inhibitor) and tocilizumab (IL-6 receptor antagonist). The study focuses on safety and immunologic activity of this multi-agent in situ immunomodulation approach.

ClinicalTrials.gov ID: NCT04616248

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.

HealthScout 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.

HealthScout 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.

HealthScout 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.

HealthScout 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 Phase 1, Multicenter, Open-Label, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of Intravenously Administered LP-284 in Adult Patients With Relapsed or Refractory Lymphomas and 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.

HealthScout AI summary: Adults with relapsed/refractory B‑cell non‑Hodgkin lymphomas or advanced solid tumors lacking effective options receive IV LP‑284 on Days 1, 8, and 15 of 28‑day cycles; expansion focuses on DLBCL and MCL after ≥2 prior lines. LP‑284 is a small‑molecule acylfulvene DNA‑alkylating agent that induces double‑strand breaks and may be preferentially active in tumors with DNA damage response defects (e.g., ATM loss), independent of TP53 status.

ClinicalTrials.gov ID: NCT06132503

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.

HealthScout 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.

HealthScout 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

A Phase 1 Study of Peposertib (M3814) and Low-Dose Liposomal Doxorubicin (Doxil®) in Patients With Metastatic Leiomyosarcoma and Other Soft Tissue Sarcomas

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.

HealthScout AI summary: Adults with metastatic or unresectable soft tissue sarcoma—emphasis on leiomyosarcoma—after prior therapy (including limited prior anthracycline) receive oral peposertib (DNA-PK inhibitor targeting NHEJ repair) continuously with low-dose pegylated liposomal doxorubicin every 28 days. Includes dose escalation across selected STS subtypes and a leiomyosarcoma expansion; requires biopsy-amenable disease, allows treated/stable CNS metastases, and excludes significant cardiac dysfunction and prior DNA-PK inhibitor exposure.

ClinicalTrials.gov ID: NCT05711615