Clinical Trials for Sarcoma

A Phase 3, Randomized, Double-blind, Multicenter Study of MK-1084 in Combination With Pembrolizumab Compared With Pembrolizumab Plus Placebo as Firstline Treatment of Participants With KRAS G12C-Mutant, Metastatic NSCLC With PD-L1 TPS ≥50%

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

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

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: This trial enrolls adults with newly diagnosed, metastatic KRAS G12C-mutant NSCLC and high PD-L1 expression (TPS ≥50%), randomizing them to pembrolizumab plus either MK-1084—a selective KRAS G12C inhibitor—or placebo as first-line treatment. Key exclusions include prior systemic therapy for metastatic disease, active CNS disease, and certain comorbidities.

ClinicalTrials.gov ID: NCT06345729

A Phase 2 Open-label Basket Study to Evaluate the Efficacy and Safety of Orally Administered Reversible Tyrosine Kinase Inhibitor BAY 2927088 in Participants With Metastatic or Unresectable Solid Tumors With HER2-activating Mutations

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

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

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: This trial enrolls adults with metastatic or unresectable solid tumors (excluding NSCLC) harboring activating HER2 mutations, who have progressed on standard therapy or have no satisfactory alternatives. Patients receive BAY2927088, an oral reversible tyrosine kinase inhibitor targeting mutant HER2 and EGFR.

ClinicalTrials.gov ID: NCT06760819

A Single-Arm, Open-label Phase II Trial Testing the Activity of XL092 (Zanzalintinib) in Patients With Advanced Leiomyosarcoma

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

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

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 metastatic or unresectable leiomyosarcoma after at least two prior systemic regimens (≤2 prior TKIs), ECOG 0–1, receive oral zanzalintinib (XL092), a multi-kinase inhibitor of VEGFR2, MET, and TAM (TYRO3/AXL/MER), given continuously in 14‑day cycles until progression/toxicity. Key exclusions include prior XL092, significant cardiovascular/bleeding risk, unstable CNS disease, and concurrent oral anticoagulants.

ClinicalTrials.gov ID: NCT06571734

ADI-PEG 20 or Placebo Plus Gemcitabine and Docetaxel in Previously Treated Subjects With Leiomyosarcoma (ARGSARC): A Randomized, Double Blind, Multi-Center Phase 3 Trial

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

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

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 advanced or metastatic grade 2–3 leiomyosarcoma (uterine or non‑uterine) after 1–2 prior systemic regimens including doxorubicin, ECOG 0–1, receive gemcitabine/docetaxel plus either ADI‑PEG 20 or placebo. ADI‑PEG 20 (pegargiminase) is a pegylated arginine deiminase that depletes extracellular arginine to target ASS1‑deficient, arginine‑auxotrophic tumors.

ClinicalTrials.gov ID: NCT05712694

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ersodetug in Patients With Inadequately Controlled Hypoglycemia Due to Tumor-Associated Hyperinsulinism (tHI)

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

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

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 tumor-associated hyperinsulinism—either insulin-secreting tumors or IGF‑2–mediated NICT—with refractory hypoglycemia despite standard therapies; ambulatory ICT patients are randomized to ersodetug (RZ358) 9 mg/kg IV plus standard care vs placebo, while hospitalized ICT/NICT and ambulatory IGF‑secreting tumor patients receive open‑label ersodetug. Ersodetug is a fully human monoclonal antibody that negatively allosterically modulates the insulin receptor to attenuate excessive insulin/IGF‑2 signaling to reduce hypoglycemia.

ClinicalTrials.gov ID: NCT06881992

A Phase 2 Trial of Zanzalintinib in Advanced/Metastatic Bone Sarcomas (ZAMBONE)

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

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

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 unresectable locally advanced or metastatic primary bone sarcomas—osteosarcoma, Ewing sarcoma, grade 2–3 conventional chondrosarcoma with RECIST progression within 12 weeks, or other rare bone sarcomas—who are relapsed/refractory after ≥1 prior systemic therapy (≤2 prior lines in advanced/metastatic setting), ECOG 0–2, measurable disease, and no prior VEGF-targeted TKI. Treatment is oral once-daily zanzalintinib monotherapy, an investigational multi-target TKI inhibiting VEGFR2, MET, and TAM kinases (AXL/MER/TYRO3), continued until progression or unacceptable toxicity.

ClinicalTrials.gov ID: NCT07193550

Vonescimab for the Treatment of Previously Treated Advanced or Unresectable Leiomyosarcoma - a Phase II Trial

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

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

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 unresectable or metastatic leiomyosarcoma, ECOG 0–2, measurable disease, and 1–3 prior systemic therapy lines are treated with single-agent IV ivonescimab every 3 weeks for up to 24 months. Ivonescimab is a bispecific antibody targeting PD-1 and VEGF, combining checkpoint blockade with anti-angiogenic activity; patients with prior PD-1/PD-L1 or VEGF-targeted therapy are excluded.

ClinicalTrials.gov ID: NCT07516925

Phase 2 Trial of Zanzalintinib and Pembrolizumab in Select Subtypes of Advanced/Metastatic Soft-tissue Sarcoma

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

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

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: Single-arm study for adults with measurable advanced/metastatic undifferentiated pleomorphic sarcoma, myxofibrosarcoma, high-grade pleomorphic sarcoma, or high-grade undifferentiated sarcoma, ECOG 0–2, without prior checkpoint inhibitor therapy. Treatment is zanzalintinib (XL092), an oral multikinase inhibitor targeting VEGFR2, MET, and TAM kinases (TYRO3/AXL/MER), plus pembrolizumab anti–PD-1 immunotherapy.

ClinicalTrials.gov ID: NCT07283731

An Open-label, Single-arm, Multicohort, Phase 2 Study to Assess the Efficacy and Safety of Tabelecleucel in Subjects With Epstein-Barr Virus-associated Diseases (EBVision)

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

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

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: Enrolling children and adults with EBV-positive disorders who lack suitable first-line options or have relapsed/refractory disease, including PID/AID-associated EBV+ LPD, CNS-involved EBV+ PTLD, PTLD where rituximab/chemotherapy is inappropriate (including CD20‑negative), and rapidly progressive EBV+ sarcomas. Participants receive tabelecleucel, an allogeneic, partially HLA‑matched EBV‑specific cytotoxic T‑cell therapy targeting EBV antigens (EBNA/LMP), given IV on Days 1, 8, and 15 of 35‑day cycles until response or progression.

ClinicalTrials.gov ID: NCT04554914

A Phase IIa Open Label Study Evaluating the Preliminary Efficacy of Intratumoural Tigilanol Tiglate in Advanced and/or Metastatic Soft Tissue Sarcoma of the Extremities and Body Wall.

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

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

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: Adults with advanced or metastatic soft tissue sarcoma of the extremities/body wall/scalp with at least one palpable or ultrasound‑guided injectable lesion receive intratumoural tigilanol tiglate (EBC‑46), a plant‑derived protein kinase C modulator that induces rapid vascular disruption and hemorrhagic necrosis for local tumor ablation. Single or multiple injections (up to 3.6 mg/m2) are evaluated for local ablation and systemic disease control, with RECIST responses assessed in Stage 2.

ClinicalTrials.gov ID: NCT05755113