Clinical Trials for Sarcoma

An Open-Label, Multicenter, First-in-Human, Phase 1 Dose-Escalation and Multicohort Expansion Study of INBRX-109 in Subjects with Locally Advanced or Metastatic Solid Tumors Including Sarcomas

Active drug

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

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.

HealthScout AI summary: This trial enrolls patients with locally advanced or metastatic solid tumors—including specific cohorts for Ewing sarcoma, colorectal adenocarcinoma, malignant pleural mesothelioma, gastric adenocarcinoma, and SDH-deficient/GIST—who receive INBRX-109, a tetravalent agonistic DR5 antibody that induces tumor cell apoptosis, as monotherapy or in combination with standard chemotherapy regimens. Eligible patients must have measurable disease, good organ function and performance status, and no prior DR5 agonist exposure.

ClinicalTrials.gov ID: NCT03715933

A Phase 1 Study of FF-10850 Topotecan Liposome Injection in Advanced Solid Tumors Including Ovarian and Cervical Carcinoma, Sarcomas, and Neuroendocrine Tumors Including Small Cell Lung Cancer and Merkel Cell Carcinoma

Active drug

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

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.

HealthScout AI summary: Adults with metastatic or unresectable solid tumors lacking standard options, with expansion cohorts for ovarian cancer and Merkel cell carcinoma, receive FF-10850, a dihydrosphingomyelin-based liposomal topotecan (topoisomerase I inhibitor) IV on Days 1 and 15 of 28-day cycles at the RP2D of 2 mg/m². Single-agent therapy aims to assess safety and preliminary activity, with manageable hematologic toxicity observed and early responses in ovarian and Merkel cell cohorts.

ClinicalTrials.gov ID: NCT04047251

Adopting a Functional Precision Medicine Approach For Individualized Pediatric Cancer Treatments

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.

HealthScout AI summary: Children, adolescents, and young adults (≤21 years) with relapsed or refractory solid or hematologic malignancies and accessible tumor tissue undergo ex vivo drug sensitivity testing integrated with genomic profiling to guide individualized therapy selection. Treating physicians may use matched, typically approved monotherapies or combinations based on predicted sensitivity; outcomes are compared with contemporaneous patients receiving non–FPM standard-of-care therapy.

ClinicalTrials.gov ID: NCT05857969

Phase II Study of Pacritinib in Kaposi Sarcoma Herpesvirus (KSHV)-Associated Multicentric Castleman Disease and KSHV-Associated Inflammatory Cytokine Syndrome (KICS)

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.

HealthScout AI summary: Enrolling adults with symptomatic KSHV-associated MCD or KICS (many HIV-positive) with at least one symptom and lab abnormality, ECOG ≤3, and without life/organ-threatening disease or symptomatic visceral KS. Single-arm therapy is pacritinib 200 mg PO BID for up to 24 weeks; pacritinib is a JAK2/TYK2-family and IRAK1 inhibitor that suppresses IL-1/IL-6 signaling (including gp130/vIL-6), aiming to improve inflammatory symptoms and labs and assess effects on concurrent Kaposi sarcoma.

ClinicalTrials.gov ID: NCT06052618

A Phase 2 Trial of Ixazomib for Kaposi Sarcoma

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.

HealthScout AI summary: Single-arm study of oral ixazomib, a reversible 20S proteasome inhibitor, for adults with measurable cutaneous Kaposi sarcoma (HIV-positive on stable ART or HIV-negative), excluding symptomatic visceral disease and significant neuropathy/comorbidities. Ixazomib is given on days 1, 8, and 15 of 28-day cycles for up to 12–24 cycles, with efficacy by ACTG response and close safety/virologic monitoring.

ClinicalTrials.gov ID: NCT04305691

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

Active drug

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

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.

HealthScout 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

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

Low burden on patient

The trial has a low burden on patients. An example would be a trial testing an oral drug, with scans every 12 weeks which would be similar to 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.

HealthScout 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 II, Randomized, Open-label Study to Assess the Efficacy, Safety, and Pharmacokinetics (PK) of Maintenance Cabozantinib (XL184) Plus Best Supportive Care (BSC) Versus BSC in Children, Adolescents and Young Adults (AYA) With Unresectable Residual Osteosarcoma Either at Diagnosis or at First Relapse After Standard Treatment

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.

HealthScout AI summary: Children, adolescents, and young adults (5–30 years) with high‑grade osteosarcoma and unresectable residual disease after standard chemotherapy (no radiographic progression) are randomized to maintenance cabozantinib plus best supportive care vs best supportive care alone. Cabozantinib is an oral multi‑kinase inhibitor (MET, VEGFR2, AXL) aimed at prolonging progression-free survival; crossover to cabozantinib is allowed at progression from the control arm.

ClinicalTrials.gov ID: NCT06341712

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

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.

HealthScout 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

MISTOSUS: Iscador® P (Mistletoe) Immunotherapy To Improve Event Free Survival In Patients With Relapsed Osteosarcoma After Resection Of Pulmonary Metastases

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.

HealthScout AI summary: Single-arm study for patients aged 8 to <30 with relapsed osteosarcoma who have had complete resection of all pulmonary metastases within 8 weeks, good organ function, and no active extra-pulmonary disease. Participants receive subcutaneous Iscador P (Viscum album mistletoe extract) three times weekly with individualized dose escalation for up to 52 weeks; the extract is an immunomodulatory biologic with lectins/viscotoxins aiming to enhance anti-tumor immunity and potential cytotoxicity.

ClinicalTrials.gov ID: NCT05726383