Clinical Trials for Sarcoma

A Phase I/Ib Study of Losartan in Combination With Sunitinib in the Treatment of Pediatric and Adult Patients With Relapsed or Refractory Osteosarcoma

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.

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: Pediatric and adult patients (≥10 years) with relapsed/refractory osteosarcoma after ≥1 prior systemic therapy, without curative options and with adequate organ function, receive oral losartan (AT1R blocker aimed at modulating tumor stroma/immune chemokines) plus sunitinib (multikinase VEGFR/PDGFR/c-KIT inhibitor) on a 4-weeks-on/2-weeks-off schedule. Key exclusions include surface/periosteal osteosarcoma, active CNS metastases, significant cardiac disease/QTc prolongation, uncontrolled hypertension, recent major surgery, and use of strong CYP3A4 modulators or QT‑prolonging drugs.

ClinicalTrials.gov ID: NCT03900793

Phase I Dose Escalation Study of FGFR4 Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory Rhabdomyosarcoma

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 (3–39 years) with relapsed/refractory rhabdomyosarcoma after ≥2 prior regimens receive fludarabine/cyclophosphamide lymphodepletion followed by a single infusion of autologous FGFR4-directed CAR T cells (3A11; second-generation CAR targeting the FGFR4 receptor tyrosine kinase, with truncated EGFR tag for tracking/depletion). Prior stable CNS disease allowed; trial assesses safety, feasibility, and preliminary activity across dose levels (1×10^5–1×10^7 CAR T cells/kg).

ClinicalTrials.gov ID: NCT06865664

The TNT Protocol: A Phase 2 Study Using Talimogene Laherparepvec,Nivolumab and Trabectedin as First, Second/Third Line Therapy for Advanced Sarcoma, Including Desmoid Tumor and Chordoma

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.

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 with unresectable or metastatic sarcoma (including desmoid tumor and chordoma) with measurable disease and at least one injectable lesion receive intratumoral talimogene laherparepvec (oncolytic HSV‑1 expressing GM‑CSF) plus nivolumab (PD‑1 inhibitor) and trabectedin (DNA minor-groove binder) as first–third line therapy. Open-label single-arm regimen treats up to 1 year; excludes active significant immunosuppression/autoimmunity, active CNS mets needing high-dose steroids, HSV-1 complications, and need for systemic antivirals.

ClinicalTrials.gov ID: NCT03886311

VITAS: Atezolizumab in Combination With Chemotherapy for Pediatric Relapsed/Refractory Solid Tumors: An Open-label, Phase II, Single-arm, Multi-center Trial

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.

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: Pediatric and young adult patients (6 months–30 years) with relapsed/refractory solid tumors (excluding lymphoma), including a dedicated efficacy cohort for PD-L1–enriched, measurable rhabdomyosarcoma, eligible if adequate organ function and no prior PD-1/PD-L1 therapy. Treatment is atezolizumab (anti–PD-L1) combined with vincristine, irinotecan, and temozolomide in 21-day cycles until progression/toxicity.

ClinicalTrials.gov ID: NCT04796012

A Phase 1/2 Clinical Trial of the Novel Topoisomerase I Inhibitor PEEL-224 as a Single Agent and in Combination With Vincristine and Temozolomide in Children With Refractory, Progressive or Relapsed 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: Children and adolescents with refractory, progressive, or relapsed non-CNS solid tumors (Phase 1; 1–18 years) receive PEEL-224, a PEGylated topoisomerase I inhibitor prodrug delivering SN22, either alone or with vincristine and temozolomide; Phase 2 enrolls neuroblastoma (1–30 years) and rhabdomyosarcoma (1–18 years) cohorts at the RP2D for the combination. CNS primaries/metastases are excluded; prior irinotecan/temozolomide permitted.

ClinicalTrials.gov ID: NCT06721689

Disulfiram With Copper Gluconate and Liposomal Doxorubicin in Patients With Treatment-Refractory 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.

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: Single-arm dose-escalation of oral disulfiram plus copper gluconate with liposomal doxorubicin for children and adults with relapsed/refractory sarcomas and measurable disease. Disulfiram (ALDH inhibitor) complexed with copper forms CuET that inhibits proteasome-associated pathways and cancer stem cell–like properties to potentially overcome anthracycline resistance; regimen includes a 7-day DSF/Cu lead-in and liposomal doxorubicin 30 mg/m2 IV Day 1 of 28-day cycles.

ClinicalTrials.gov ID: NCT05210374

Phase 1, Open-Label, Multicenter, First-In-Human Trial of Ds-2243a in 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 HLA-A2–positive advanced solid tumors (synovial sarcoma, myxoid/round cell liposarcoma, NSCLC adenocarcinoma/squamous, or urothelial carcinoma) after appropriate prior therapy receive subcutaneous DS-2243a, a bispecific T‑cell engager targeting CD3 and the HLA‑A*02/NY‑ESO‑1 peptide complex, with step-up dosing. Includes dose escalation and tumor-specific expansion; excludes prior NY‑ESO‑1–targeted therapy and requires measurable disease and ECOG 0–1.

ClinicalTrials.gov ID: NCT06644755

A Phase 1, Open-label, Multicenter Study of LTZ-301 in Subjects With Relapsed/Refractory Non-Hodgkin Lymphoma

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/refractory B‑cell non‑Hodgkin lymphoma after ≥2 prior regimens (ECOG 0–1) receive LTZ‑301 monotherapy, an investigational bispecific myeloid‑cell engager antibody targeting CD79b to recruit monocytes/macrophages and induce phagocytosis for B‑cell depletion. Excludes CLL/Richter, prior allo/solid organ transplant, recent ASCT/CAR‑T, active CNS disease, HIV, active autoimmune disease, and significant cardiovascular events.

ClinicalTrials.gov ID: NCT07121946

TCR-αβ+ and CD19+ Depleted KIR/KIR Ligand-mismatched Haploidentical Hematopoietic Stem Cell Transplant and Zoledronate for Pediatric Relapsed/Refractory Hematologic Malignancies and High Risk Solid Tumors

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.

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: Pediatric patients with relapsed/refractory hematologic malignancies (AML with <20% blasts, high-risk ALL, HL/NHL, MDS/MPN) or selected high-risk solid tumors (neuroblastoma, Ewing/PNET, rhabdomyosarcoma, osteosarcoma) lacking a timely matched donor undergo TCR-αβ+ and CD19+ depleted KIR/KIR-ligand–mismatched haploidentical PBSC transplant after risk-adapted conditioning. Post-transplant zoledronate (nitrogen-containing bisphosphonate; farnesyl pyrophosphate synthase inhibitor) is given to activate γδ T cells and potentially enhance antitumor immunity while monitoring GVHD, engraftment, and immune reconstitution.

ClinicalTrials.gov ID: NCT02508038

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.

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 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