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

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.

HealthScout 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.

HealthScout 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

Interleukin-15 Armored Glypican-3-specific Chimeric Antigen Receptor Expressing Autologous T Cells as Immunotherapy for Children With Solid Tumors

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.

HealthScout AI summary: Pediatric and young adult patients (1–21 years) with relapsed/refractory GPC3-positive solid tumors, including eligible hepatocellular carcinoma, receive autologous CAR T cells engineered to target glypican-3 and constitutively express IL-15, with an inducible caspase-9 safety switch, after fludarabine/cyclophosphamide lymphodepletion. Retreatment at the same dose is permitted for responders without dose-limiting toxicity; key exclusions include uncontrolled infection, prior transplant, and high-dose steroids.

ClinicalTrials.gov ID: NCT04377932

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

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.

HealthScout 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

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.

HealthScout 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

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.

HealthScout 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.

HealthScout 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

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.

HealthScout 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

Phase I Study of Aerosol Gemcitabine in Patients With Solid Tumors and Pulmonary Metastases

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.

HealthScout AI summary: Adolescents and adults (12–50) with histologically confirmed solid tumors metastatic to the lungs, ECOG ≤2 and adequate organ/pulmonary function, receive on‑site aerosolized gemcitabine via nebulizer twice weekly in 28‑day cycles, including those previously treated with systemic gemcitabine. Gemcitabine is a nucleoside analog prodrug that inhibits ribonucleotide reductase and DNA synthesis; trial excludes active asthma or significant pulmonary symptoms and seeks to define pulmonary MTD and preliminary activity.

ClinicalTrials.gov ID: NCT03093909

A Multi-cohort Study of Retifanlimab With or Without Gemcitabine and Docetaxel in Patients With Advanced 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.

HealthScout AI summary: Adults with advanced, unresectable or metastatic high‑grade soft tissue sarcoma (ECOG 0–1, no prior systemic therapy for advanced disease) receive gemcitabine/docetaxel with the anti–PD‑1 antibody retifanlimab, with histology-specific cohorts; a separate biomarker-selected cohort tests retifanlimab monotherapy in previously treated patients with an immune-enriched tumor microenvironment. Retifanlimab blocks PD‑1 to restore antitumor T‑cell activity.

ClinicalTrials.gov ID: NCT04577014