Clinical Trials for Sarcoma

A Phase 1/2a, Open-Label, Dose Escalation and Expansion Study of the Safety and Tolerability of T3011 Administered Via Intratumoral Injection as a Single Agent and in Combination With Intravenous Pembrolizumab in Patients With Advanced or Metastatic Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

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 advanced/metastatic solid tumors requiring at least one injectable lesion (ECOG 0–1) receive intratumoral T3011—an engineered oncolytic HSV‑1 expressing IL‑12 and an anti‑PD‑1 antibody—either as monotherapy in melanoma, HNSCC post‑platinum/PD‑(L)1, sarcoma, or cSCC, or combined with IV pembrolizumab in previously treated metastatic NSCLC without EGFR/ALK alterations. Excludes patients with uninjectable disease, high‑risk injection sites, active autoimmune disease requiring immunosuppression, active HSV, significant cardiopulmonary disease, CNS metastases, or active viral infections.

ClinicalTrials.gov ID: NCT04370587

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

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 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

A Feasibility Multicenter Phase I Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

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: This trial enrolls adults (ECOG 0-2) with locally advanced or metastatic cancers eligible for atezolizumab, investigating therapeutic drug monitoring-based personalized dosing of atezolizumab (anti-PD-L1 immune checkpoint inhibitor) as monotherapy or combined with other approved agents. Patients initially receive standard dosing, then transition to adaptive, lower-frequency fixed dosing based on plasma levels.

ClinicalTrials.gov ID: NCT06066138

Phase 2 Study of Avapritinib in Patients With CKIT or PDGFRA Mutation-Positive Malignant Solid Tumors

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.

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: This trial enrolls adults with locally advanced or metastatic non-GIST solid tumors (such as melanoma, sarcoma, or primary CNS tumors) harboring activating mutations in CKIT or PDGFRA, who have no effective standard therapy options. Patients receive avapritinib, an oral tyrosine kinase inhibitor selective for CKIT and PDGFRA mutations.

ClinicalTrials.gov ID: NCT04771520

Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART): Adaptive Clinical Treatment (ACT)

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: This trial enrolls adults with advanced sarcoma, prostate, breast, ovarian, or pancreatic cancers who have progressed after prior systemic therapy, assigning individualized regimens—including targeted agents like CDK4/6 inhibitors (abemaciclib), PARP inhibitors (olaparib), EGFR inhibitors (gefitinib, osimertinib), endocrine therapies, and chemotherapeutics—based on serial molecular profiling and multidisciplinary tumor board review. Patients may switch treatments upon progression or toxicity according to ongoing molecular and proteomic data.

ClinicalTrials.gov ID: NCT06630325

A Phase 1/2, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Recommended Phase 2 Dose (RP2D), and Efficacy of Lurbinectedin Monotherapy in Pediatric Participants With Previously Treated Solid Tumors Followed by Expansion to Assess Efficacy and Safety in Pediatric and Young Adult Participants With Relapsed/Refractory Ewing Sarcoma.

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 dose-escalation/expansion of lurbinectedin monotherapy for pediatric patients with previously treated solid tumors (≥2 to <18 years) to establish RP2D, followed by treatment of pediatric/young adult patients (≥2 to ≤30 years) with relapsed/refractory Ewing sarcoma. Lurbinectedin is a DNA minor-groove binder that inhibits oncogenic transcription and induces DNA double-strand breaks; key exclusions include significant QTc prolongation, active CNS disease requiring steroids, prior lurbinectedin/trabectedin, and recent intensive therapy.

ClinicalTrials.gov ID: NCT05734066

Lurbinectedin in FET-Fusion Tumors (LIFFT)

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: Enrolling patients ≥10 years with recurrent/relapsed solid tumors harboring FET fusions (EWSR1, FUS, TAF15), including an efficacy cohort for EWS-FLI1–positive relapsed/refractory Ewing sarcoma, to receive lurbinectedin IV on days 1 and 4 of 28-day cycles. Lurbinectedin is a selective inhibitor of oncogenic transcription that binds the DNA minor groove, suppressing fusion-driven transcription (e.g., EWS-FLI1) and tumor-associated macrophages.

ClinicalTrials.gov ID: NCT05918640

Allogeneic Stem Cell Transplantation Utilizing Alpha/Beta T Cell and CD19+ B Cell Depletion With Zoledronic Acid in Combination to Treat Pediatric, Adolescent, and Young Adult Patients With Relapsed/Refractory 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.

TrialFetch AI summary: Pediatric, adolescent, and young adult patients (6 months–25 years) with relapsed/refractory high-risk solid tumors undergo haploidentical allogeneic HSCT using αβ T-cell and CD19+ B-cell–depleted grafts, with adjunct zoledronic acid. Zoledronic acid, a nitrogen-containing bisphosphonate that inhibits farnesyl pyrophosphate synthase and activates γδ T cells, is used to enhance graft-versus-tumor effects.

ClinicalTrials.gov ID: NCT06625190

A Phase 1/2 Open Label, Basket Study to Assess the Safety, Tolerability and Anti-Tumor Activity of Afamitresgene Autoleucel in Pediatric Subjects With MAGE-A4 Positive 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.

TrialFetch AI summary: Pediatric and young adult patients (2–17 with synovial sarcoma; 2–21 with MPNST, neuroblastoma, or osteosarcoma) with HLA‑A*02 positivity and centrally confirmed MAGE‑A4–expressing, measurable disease receive leukapheresis, fludarabine/cyclophosphamide lymphodepletion, and a single infusion of afamitresgene autoleucel. Afami‑cel is an autologous TCR-engineered T‑cell therapy targeting MAGE‑A4 presented by HLA‑A*02, with expected T‑cell therapy toxicities including CRS and cytopenias.

ClinicalTrials.gov ID: NCT05642455

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

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.

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: 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