Clinical Trials for Sarcoma

A First-in-human, Open-label Trial to Evaluate the Combination of ACTengine® IMA203 With mRNA-4203 in Previously Treated, Unresectable or Metastatic Cutaneous Melanoma or Synovial Sarcoma Patients (ACTengine® IMA203-102)

TrialFetch AI summary: Adults with HLA‑A*02:01–positive unresectable or metastatic cutaneous melanoma (post–PD‑1) or synovial sarcoma needing further therapy receive autologous PRAME‑targeted TCR‑T cells (ACTengine IMA203) after lymphodepletion plus low‑dose IL‑2, combined with a PRAME mRNA vaccine (mRNA‑4203) to boost PRAME‑specific T‑cell responses. Key exclusions include active brain metastases, significant autoimmune/cardiac disease, prior allogeneic transplant, active viral infections, and hypersensitivity to study agents.

ClinicalTrials.gov ID: NCT06946225

A First-In-Human Phase 1 Trial of T-Cell Membrane-Anchored Tumor Targeted Il12 (Attil12)- T-Cell Therapy in Subjects With Advanced/Metastatic Soft Tissue and Bone Sarcoma

TrialFetch AI summary: Adolescents and adults (≥12) with advanced/metastatic soft tissue or bone sarcoma after ≥1 prior systemic therapy (ECOG 0–1); dose‑expansion focuses on unresectable recurrent/metastatic osteosarcoma. Treatment is cyclophosphamide lymphodepletion followed by a single infusion of autologous T cells engineered to display tumor‑targeted, membrane‑anchored IL‑12 that binds cell‑surface vimentin to localize IL‑12 activity and boost intratumoral IFN‑γ–mediated immunity.

ClinicalTrials.gov ID: NCT05621668

A Dose Finding Study of MiniBeam RadioTherapy for Skin and Superficial Soft Tissue Tumors (MBRT1)

TrialFetch AI summary: Adults with primary, recurrent, or metastatic skin or superficial soft tissue tumors suitable for palliative orthovoltage RT receive MiniBeam Radiation Therapy delivered via a tungsten slit collimator in 2–3 fractions, which spatially fractionates dose into high “peaks” and low “valleys” to spare normal tissue. Excludes lesions likely to fully respond to standard palliative RT, prior overlapping RT, recent/planned BRAF/VEGF-targeted therapy or cytotoxic chemo during the DLT window, and lesions with unavoidable spinal cord exposure.

ClinicalTrials.gov ID: NCT07062003

Metastatic Ewing's Trial Testing Schedule Enhancement to Improve Outcomes

TrialFetch AI summary: Newly diagnosed patients (>1 year) with widely metastatic Ewing sarcoma or metastatic CIC-rearranged sarcoma (no prior systemic therapy beyond an initial VDC cycle) receive an intensive, sequential 2-year regimen: VDC induction; IrIVA; cabozantinib during primary-site radiation (multi-kinase inhibitor of MET/VEGFR2/AXL); followed by topotecan/cyclophosphamide, high-dose ifosfamide, irinotecan/temozolomide, and prolonged alternating oral/IV maintenance (cyclophosphamide/etoposide and vincristine/liposomal doxorubicin). Aims to exploit non–cross-resistant “second strikes” and antiangiogenic targeting to suppress resistant clones; tumor tissue submission required.

ClinicalTrials.gov ID: NCT07194044

T Cell Membrane-Anchored Tumor-Targeted IL12 -Modified TIL Cell Therapy (attIL12-TIL) for Advanced/Metastatic Soft Tissue and Bone Sarcoma Patients.

TrialFetch AI summary: Adolescents and adults with advanced/metastatic soft tissue or bone sarcomas (expansion in unresectable recurrent/metastatic liposarcoma) receive cyclophosphamide conditioning followed by a single infusion of autologous TILs engineered to express a membrane-anchored, tumor-targeted IL‑12 payload to localize cytokine signaling in the TME. Aims to establish safety/dose and assess preliminary activity, with 4-month PFS as the key endpoint in liposarcoma.

ClinicalTrials.gov ID: NCT06474676

A Phase II Trial of Tebentafusp in HLA-A*02:01 Positive Patients With Advanced Clear Cell Sarcoma

TrialFetch AI summary: Adults with unresectable or metastatic, HMB-45–positive clear cell sarcoma and measurable disease; HLA-A*02:01–positive patients receive tebentafusp, a gp100-directed TCR/anti-CD3 bispecific (ImmTAC) that redirects T cells, while HLA-A*02:01–negative patients get physician’s choice therapy. Key notes: weekly IV step-up dosing; common early toxicities include cytokine-mediated infusion reactions and rash.

ClinicalTrials.gov ID: NCT06942442

A Phase I Trial of Zanzalintinib Combined With Eribulin in Advanced Liposarcoma and Leiomyosarcoma

TrialFetch AI summary: Adults with unresectable/metastatic leiomyosarcoma or adipocytic sarcoma (excluding pure WD LPS and low‑grade LMS), ECOG 0–1, after 1–4 prior lines receive eribulin (D1,8 q21d) plus oral zanzalintinib (XL092), a multi‑target TKI of VEGFR2/MET/TAM kinases aimed at anti‑angiogenic and immunomodulatory effects. Allows treated/stable brain mets; key exclusions include significant CV disease, bleeding risk, GI perforation risk, moderate–severe hepatic impairment, and prior zanzalintinib.

ClinicalTrials.gov ID: NCT06957431

URSa-1: A Minibasket Study of Pembrolizumab in Ultra-Rare Sarcomas

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.

TrialFetch AI summary: Adults (≥18) with recurrent or metastatic, measurable pleomorphic liposarcoma, PEComa, epithelioid sarcoma, CIC-rearranged sarcoma, or sclerosing epithelioid fibrosarcoma/low-grade fibromyxoid sarcoma who have progressed after their most recent therapy (ECOG 0–1; 1–3 prior systemic lines allowed; treated/stable brain metastases allowed; no prior PD-1/PD-L1/PD-L2 therapy). Single-arm cohorts receive pembrolizumab IV every 6 weeks, an anti–PD-1 monoclonal antibody checkpoint inhibitor that blocks PD-1/PD-L1/PD-L2 interactions to restore antitumor T-cell activity.

ClinicalTrials.gov ID: NCT07089992

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

TrialFetch AI summary: Eligible patients are children, adolescents, and young adults (age 1 to <24 years; >10 kg) with relapsed/refractory rhabdomyosarcoma, Ewing sarcoma, neuroblastoma, or Wilms tumor with measurable/evaluable disease after standard therapies and no known CNS involvement. After fludarabine/cyclophosphamide lymphodepletion, participants receive a single infusion of an autologous 1:1 cellular product combining B7-H3–targeted CAR T cells with PRAME antigen–specific T cells engineered with a dominant-negative TGF-β receptor II (dTβRII) to resist TGF-β–mediated immunosuppression.

ClinicalTrials.gov ID: NCT07172958

Novel RNA-lipid Particle (RNA-LP) Vaccine for Anti-PD-1 Antibody Therapy Sensitization

TrialFetch AI summary: Adults with ECOG 0–2 melanoma (stage IIB–IV with progression on or within 6 months after adjuvant anti–PD-1, including select rare subtypes with metastatic immunotherapy failure) or unresectable stage II/III–IV soft tissue sarcoma with accessible measurable disease and early resistance/need to continue anti–PD-1 therapy are enrolled, requiring surgically obtainable tumor for vaccine manufacture. Patients receive an individualized autologous total tumor mRNA vaccine formulated in DOTAP lipid particles (IV 3-dose series) intended to enhance antigen presentation/innate activation and re-sensitize to checkpoint blockade, followed by continuation/resumption of anti–PD-1 per protocol.

ClinicalTrials.gov ID: NCT05264974