Clinical Trials for Sarcoma

A Phase 1/2, Open-Label, Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity Study of Repotrectinib in Pediatric and Young Adult Subjects With Advanced or Metastatic Malignancies Harboring ALK, ROS1, NTRK1-3 Alterations

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: Open-label, single-arm study of oral repotrectinib, a next-generation macrocyclic TKI targeting ROS1, ALK, and TRK (NTRK1/2/3) with CNS penetration, in children <12 with ALK/ROS1/NTRK-altered advanced malignancies (dose-finding) and adolescents/young adults (12–25) with NTRK fusion–positive (TKI-naïve or pretreated) or ROS1-altered advanced solid tumors/ALCL. Eligible patients require measurable disease and prior progression/intolerance or lack of standard therapy; endpoints include safety/PK in pediatrics and confirmed ORR by BICR in expansion cohorts.

ClinicalTrials.gov ID: NCT04094610

TAGGED: A Phase 2 Study Using Low Dose/Metronomic Trabectedin, Gemcitabine, and Dacarbazine as 2nd/3rd/4th Line Therapy for Advanced Soft Tissue Sarcoma

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 previously treated, locally advanced or metastatic leiomyosarcoma receive a metronomic regimen of trabectedin (DNA minor-groove binder affecting transcription/repair), gemcitabine (nucleoside analog), and dacarbazine (alkylating agent) on Days 1 and 8 of 21-day cycles. Single-arm study aims to assess disease control and tolerability as later-line therapy, treating until progression or toxicity for up to 1 year.

ClinicalTrials.gov ID: NCT04535271

Phase I Trial of TURALIO (Pexidartinib, PLX3397) in Children and Young Adults With Refractory Leukemias and Refractory Solid Tumors Including Neurofibromatosis Type 1 (NF1) Associated Plexiform Neurofibromas (PN) and Tenosynovial Giant Cell Tumor (TGCT)

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: Enrolls children and young adults (3–35 years) with refractory/recurrent solid tumors (including CNS tumors, NF1-associated plexiform neurofibromas/MPNST, TGCT) or refractory AML/ALL to receive oral pexidartinib daily in 28-day cycles. Pexidartinib is a small-molecule inhibitor of CSF1R (with KIT and FLT3 activity) targeting tumor-associated macrophages and relevant oncogenic kinases.

ClinicalTrials.gov ID: NCT02390752

Open-Label, Multicenter, Phase 1 Study to Assess the Safety of P-CD19CD20-ALLO1 in Subjects With Selected Relapsed/Refractory B Cell Malignancies

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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 or refractory aggressive B-cell lymphoma after anti-CD20- and anthracycline-containing chemoimmunotherapy receive lymphodepleting chemotherapy followed by a single infusion of P-CD19CD20-ALLO1, an investigational donor-derived CAR T-cell product targeting CD19 and CD20.

ClinicalTrials.gov ID: NCT06014762

A First-in-human, Phase I, Multi-center, Open-label, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Evidence of Antitumor Activity of IDOV-Immune in Adult Participants With Advanced Solid Tumors

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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 measurable advanced solid tumors that have progressed after standard therapy or lack a standard treatment option receive a single intravenous infusion of IDOV-Immune. This engineered oncolytic vaccinia virus is designed to replicate preferentially in tumor cells, destroy them, and stimulate antitumor immunity.

ClinicalTrials.gov ID: NCT06910657

A Phase 1/2a, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of BMS-986523 As Monotherapy and in Combination With Anti-Cancer Agents in Participants With Advanced Solid Malignancies

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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: For patients with unresectable locally advanced or metastatic KRAS-mutated or KRAS-amplified solid tumors who have received, are ineligible for, or decline standard care, this study evaluates BMS-986523 alone or with pembrolizumab, cetuximab, or gemcitabine plus nab-paclitaxel. BMS-986523 is an investigational protein-degradation therapy with an undisclosed target; the pembrolizumab arm additionally requires PD-L1 expression ≥50%.

ClinicalTrials.gov ID: NCT07223047

A Randomized Phase I/II Study of Talazoparib or Temozolomide in Combination With Onivyde in Children With Recurrent Solid Malignancies and Ewing Sarcoma

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: Enrolls children/AYA age >12 months to <30 years with recurrent/refractory non-CNS solid tumors (dose-finding/expansion, including an HRR-altered cohort) and randomizes patients with first-relapse, EWSR1-rearranged Ewing sarcoma to compare efficacy. Treatment is nanoliposomal irinotecan (Onivyde; topoisomerase I–mediated DNA damage) on days 1 and 8 of 21-day cycles combined with either talazoparib (PARP1/2 inhibitor with PARP-trapping) or temozolomide (oral DNA-alkylating agent).

ClinicalTrials.gov ID: NCT04901702

A Phase 1/1B Study of ST-01156, a Small Molecule RBM39 Degrader, in Patients With Advanced Solid Malignancies

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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: Patients with metastatic or locally advanced unresectable solid tumors, ECOG performance status 0–2, and no prior RBM39-targeted therapy receive oral ST-01156 on a 5-days-on, 2-days-off schedule. ST-01156 is an investigational small molecule designed to degrade RBM39, an RNA-splicing protein.

ClinicalTrials.gov ID: NCT07197554

A Seamless Phase 1/2 Open-label Study to Evaluate the Safety, Determine the Maximum Tolerated Dose of Administered Activity, and Evaluate the Efficacy of the Therapeutic Radiopharmaceutical [Ac 225]-RTX-2358 in the Treatment of Relapsed or Refractory Sarcoma

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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 or refractory soft-tissue sarcoma after at least one prior treatment, measurable disease, and a positive FAP-targeted PET scan receive [Ac225]RTX-2358, an investigational FAP-targeted radiopharmaceutical that delivers actinium-225 alpha radiation. It is given by injection every eight weeks, with [Cu64]LNTH-1363S used for diagnostic imaging.

ClinicalTrials.gov ID: NCT07156565

Selective Antigen Specific dTβRII-expressing T Cells and B7-H3 CAR T Cells in Subjects With Relapsed/Refractory Embryonal Tumors (SABRE)

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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: Children and young adults aged 1 to under 24 years with relapsed or refractory rhabdomyosarcoma, Ewing sarcoma, neuroblastoma, or Wilms tumor receive fludarabine/cyclophosphamide lymphodepletion followed by a single infusion of autologous PRAME-specific T cells engineered to resist TGF-β–mediated immunosuppression plus B7-H3–targeted CAR T cells.

ClinicalTrials.gov ID: NCT07172958