Clinical Trials for Sarcoma

A Phase I Trial of CRD3874-SI, a STING Agonist, in Patients With Advanced/Metastatic Malignant Solid Tumors

TrialFetch AI summary: Adults with advanced/metastatic solid tumors after ≥1 prior therapy, with dose expansion focused on anti–PD-1/PD-L1–refractory or –progressed sarcoma subtypes (UPS/MFS, angiosarcoma, bone sarcoma) and Merkel cell carcinoma; ECOG 0–1 required. Patients receive weekly intravenous CRD3874-SI, an investigational small‑molecule allosteric STING agonist designed to enhance cGAMP-mediated type I interferon signaling, with 3+3 dose escalation to RP2D followed by expansion.

ClinicalTrials.gov ID: NCT06021626

Phase I/II Study of PDS01ADC Monotherapy and in Combination With M7824 in Advanced Kaposi Sarcoma

TrialFetch AI summary: Adults with biopsy‑proven advanced Kaposi sarcoma (HIV+ on stable ART or HIV−), ECOG 0–2, and ≥5 measurable cutaneous lesions; prior systemic therapy allowed. Investigational IL‑12–targeted immunocytokine PDS01ADC (NHS‑IL12) is given subcutaneously every 28 days as monotherapy or combined with bintrafusp alfa (M7824), a bifunctional PD‑L1 blocker/TGF‑β trap given IV q2w.

ClinicalTrials.gov ID: NCT04303117

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

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

Abemaciclib for Treatment of Advanced Bone and Soft Tissue Sarcoma Identified as Having CDK Pathway Alteration

TrialFetch AI summary: Adults with metastatic or unresectable sarcomas (conventional and dedifferentiated chondrosarcoma, osteosarcoma, chordoma, and most soft tissue sarcomas except WD/DD liposarcoma) with intact Rb and evidence of CDK pathway activation receive abemaciclib 200 mg PO BID. Abemaciclib is a selective CDK4/6 inhibitor targeting Cyclin D–CDK4/6–Rb signaling; prior CDK4/6 inhibitor exposure is excluded.

ClinicalTrials.gov ID: NCT04040205

A Phase 3 Randomized Controlled Trial Comparing Open vs Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma

TrialFetch AI summary: For patients <50 years with histologically confirmed osteosarcoma and resectable oligometastatic pulmonary disease (≤4 nodules/lung, 3 mm–3 cm) at initial presentation or first pulmonary relapse, this trial randomizes to open thoracotomy versus video-assisted thoracoscopic surgery (VATS) for metastasectomy. Key exclusions include unresectable primary tumor, central lesions needing anatomic resection, extrapulmonary metastases, significant pleural effusion, or prior therapeutic pulmonary metastasectomy.

ClinicalTrials.gov ID: NCT05235165

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

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

A Phase II Study of Daratumumab for Relapsed/Refractory Primary Effusion Lymphoma, Plasmablastic Lymphoma, and Multicentric Castleman Disease

TrialFetch AI summary: Adults with relapsed/refractory primary effusion lymphoma (including extracavitary/KSHV-associated large cell lymphoma), plasmablastic lymphoma, or symptomatic KSHV-associated multicentric Castleman disease (HIV+ or HIV–, ECOG up to 3) receive subcutaneous daratumumab monotherapy. Daratumumab is an anti-CD38 monoclonal antibody that induces cytotoxicity and depletes CD38+ immunosuppressive cells; dosing is weekly then spaced to every 2–4 weeks depending on cohort.

ClinicalTrials.gov ID: NCT05907759

A Phase 1 Study of APG-1252 (Pelcitoclax) and Cobimetinib in Recurrent Ovarian and Endometrial Cancers

TrialFetch 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

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

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

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