Clinical Trials for Sarcoma

A First-in-human, Phase 1/2, Multicenter, Open-label, Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of ADCE-D01, a Humanized Anti-human uPARAP Antibody Linked to a Topoisomerase I Inhibitor, in Patients With Metastatic and/or Unresectable Soft Tissue Sarcoma

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 after 1–2 prior cytotoxic regimens receive ADCE-D01, a uPARAP-targeted antibody–drug conjugate delivering a topoisomerase I inhibitor. Single-arm dose escalation/expansion assesses safety, PK, and preliminary efficacy to establish the RP2D.

ClinicalTrials.gov ID: NCT06797999

Immunotherapy For Adults With GPC3-Positive Solid Tumors Using Interleukin-15 And -21 Armored Glypican-3-Specific Chimeric Antigen Receptor Expressing Autologous T Cells

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 GPC3-positive solid tumors (notably HCC; centrally confirmed by IHC) after standard therapies receive autologous GPC3-targeted CAR T cells armored with IL-15 and IL-21 to enhance expansion/persistence, incorporating an inducible caspase-9 safety switch, following cyclophosphamide/fludarabine lymphodepletion. Optional second infusion at 4 weeks if no progression.

ClinicalTrials.gov ID: NCT06198296

LINNOVATE: A Phase 1/2 Study of Safety/Efficacy Using LURBINECTEDIN, Combined With IPILIMUMAB, and NIVOLUMAB for Advanced Soft Tissue Sarcomas

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 unresectable or metastatic soft tissue sarcoma (ECOG 0–1); Phase 1 enrolls previously treated, Phase 2 previously untreated; excludes prior PD‑1/CTLA‑4 therapy and unstable CNS mets. Treatment combines lurbinectedin (DNA minor groove binder/transcription inhibitor with TAM modulation) every 3 weeks plus fixed-dose ipilimumab (anti–CTLA‑4) and nivolumab (anti–PD‑1).

ClinicalTrials.gov ID: NCT05876715

A Phase I Trial of Combination Gemcitabine and Nab-Sirolimus in Advanced Leiomyosarcomas or Advanced Soft-Tissue Sarcomas With TSC2 or TSC1 Loss-of-function Mutations or Deletions

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 leiomyosarcoma or other soft-tissue sarcomas harboring TSC1/TSC2 loss-of-function alterations, previously treated and gemcitabine/mTOR inhibitor–naive, receive gemcitabine plus nab-sirolimus. Nab-sirolimus is an albumin-bound mTORC1 inhibitor targeting PI3K/AKT/mTOR pathway activation driven by TSC1/2 loss; treated/stable brain metastases and controlled HBV/HCV/HIV are allowed.

ClinicalTrials.gov ID: NCT06308419

Phase Ib Trial Evaluating the Combination of CDK4 Inhibitor With Immunotherapy in Patients With Sarcoma

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 study for adolescents and adults with locally advanced, unresectable, or metastatic PD-1–approved soft tissue sarcoma subtypes (e.g., UPS, myxofibrosarcoma, angiosarcoma, pleomorphic RMS/liposarcoma, ASPS) after ≥1 prior line; prior PD-1 allowed, ECOG 0–2. Patients receive a short palbociclib lead-in (CDK4/6 inhibitor) followed by pembrolizumab (anti–PD-1) to assess safety and early activity, with serial biopsies to evaluate immune modulation.

ClinicalTrials.gov ID: NCT06113809

A Phase 2 Study to Assess the Safety and Efficacy of Cobimetinib in Refractory Langerhans Cell Histiocytosis, LCH-Associated Neurodegenerative Disease, and Other Histiocytic Disorders.

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 biopsy-proven, measurable histiocytic disorders—including refractory/recurrent LCH, LCH-associated neurodegenerative disease, Erdheim-Chester disease, juvenile xanthogranuloma, Rosai-Dorfman disease, and histiocytic sarcoma—across pediatric and adult cohorts. Patients receive oral cobimetinib monotherapy, a MEK1/2 inhibitor targeting MAPK pathway–driven disease (e.g., BRAF V600E, MAP2K1, ARAF), with monitoring for class toxicities.

ClinicalTrials.gov ID: NCT04079179

A Phase Ib/II Study of the Mirdametinib in Combination With Palbociclib in Patients With Advanced Dedifferentiated Liposarcoma

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 unresectable, recurrent, or metastatic dedifferentiated liposarcoma receive oral mirdametinib (MEK1/2 inhibitor) plus palbociclib (CDK4/6 inhibitor) to evaluate safety and disease control, including patients with measurable, progressing disease and prior lines allowed (excluding prior MEK or selective CDK4 inhibitors in Phase II). Allows treated/stable brain metastases; key exclusions include significant cardiac disease/QTc >470 ms, ILD, ocular risk, strong CYP3A/UGT modulators, and inadequate organ function.

ClinicalTrials.gov ID: NCT06843967

A Phase II Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma of Soft Tissue

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: Enrolling adults ≥65 with unresectable or metastatic soft tissue leiomyosarcoma who are anthracycline-naïve and ECOG 0–2, this single-arm study tests a lower-dose weekly doxorubicin regimen (25 mg/m2 IV on days 1 and 8 every 21 days, up to 8 cycles) with dexrazoxane and pegfilgrastim. Aims to assess 12-week PFS and tolerability, with correlative studies on immune effects of anthracycline (topoisomerase II inhibitor/DNA intercalator) therapy.

ClinicalTrials.gov ID: NCT07125183

Randomized Phase 2 Study of Cabozantinib, Ipilimumab, and Nivolumab in Patients With Soft Tissue Sarcoma

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 locally advanced, unresectable soft tissue sarcoma (UPS, extraskeletal myxoid chondrosarcoma, liposarcoma, or non-uterine leiomyosarcoma), ECOG 0–2, are randomized to nivolumab plus ipilimumab versus the same doublet with cabozantinib, with crossover allowed at progression. Cabozantinib is an oral multikinase inhibitor (MET/VEGFR2/AXL) added to dual checkpoint blockade to potentially improve PFS; prior MET/VEGFR inhibitors are allowed (not cabozantinib), and treated/stable brain metastases and controlled HBV/HCV/HIV are permitted under criteria.

ClinicalTrials.gov ID: NCT05836571

A Phase II Study of ASTX727 in Patients With PRC2 Loss Malignant Peripheral Nerve Sheath Tumor (MPNST)

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: Adults with unresectable or metastatic PRC2-loss MPNST (H3K27me2/3 loss or EED/SUZ12/EZH2 alterations) after prior therapy receive oral ASTX727 (cedazuridine/decitabine) days 1–5 of 21-day cycles with pegfilgrastim support. ASTX727 combines a cytidine deaminase inhibitor to boost exposure of decitabine, a DNA hypomethylating agent that inhibits DNMT, aiming to exploit epigenetic vulnerabilities in PRC2-deficient tumors.

ClinicalTrials.gov ID: NCT04872543