Clinical Trials for Sarcoma

Phase 2 Proof of Concept Study of Nivolumab and Ipilimumab in Children and Young Adults With Relapsed or Refractory INI1-negative Cancers

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.

HealthScout AI summary: Enrolls children and young adults with relapsed/refractory INI1-negative or SMARCA4-deficient cancers, including extracranial solid tumors and primary CNS tumors, who lack standard options and have measurable disease. Treatment is nivolumab (PD-1 inhibitor) plus ipilimumab (CTLA-4 inhibitor) for four 21-day cycles, then nivolumab maintenance.

ClinicalTrials.gov ID: NCT04416568

Interleukin-15 and -21 Armored Glypican-3-specific Chimeric Antigen Receptor Expressing Autologous T Cells as an Immunotherapy for Children With Solid Tumors (CARE)

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.

HealthScout AI summary: Children and young adults (1–21 years) with relapsed/refractory GPC3-positive solid tumors (including HCC) receive cyclophosphamide/fludarabine lymphodepletion followed by a single infusion of autologous GPC3-targeted CAR T cells co-expressing IL-15 and IL-21, with an inducible caspase-9 safety switch. The investigational CAR targets the tumor proteoglycan GPC3, with IL-15/IL-21 “armoring” intended to enhance T-cell expansion and persistence.

ClinicalTrials.gov ID: NCT04715191

GALLANT: A Phase 2 Study Using Metronomic Gemcitabine, Doxorubicin, Docetaxel and Nivolumab as Second/Third Line Therapy for Advanced 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.

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 unresectable or metastatic sarcoma after at least one prior therapy (ECOG 0–2) receive metronomic gemcitabine, doxorubicin, and docetaxel on days 1 and 8 of 21-day cycles, with nivolumab (PD-1 inhibitor) added from cycle 2 onward, continued up to one year. Excludes patients with active autoimmune disease requiring systemic therapy or hypersensitivity to study drugs.

ClinicalTrials.gov ID: NCT04535713

A Phase I Trial of Cabozantinib (XL184) in Combination With High-dose Ifosfamide in Adults and Children With Relapsed/Refractory Ewing Sarcoma and Osteosarcoma

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.

HealthScout AI summary: Relapsed/refractory Ewing sarcoma (including Ewing-like) or osteosarcoma with measurable disease; enrolling children and adults (dose-finding 12–40 years; dose-confirmation 5 to <12 years) with adequate organ function and no prior high-dose ifosfamide. Treatment combines oral cabozantinib (multikinase inhibitor of MET/VEGFR2/AXL) with high-dose ifosfamide to define safety/MTD and assess preliminary activity.

ClinicalTrials.gov ID: NCT06156410

Phase 2 Study of Cabozantinib as a Maintenance Agent to Prevent Progression or Recurrence in High-Risk Pediatric 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.

HealthScout AI summary: Maintenance cabozantinib (oral multi-kinase inhibitor of MET/VEGFR2/AXL/RET) for 12 months in children, adolescents, and young adults (≥18 months to <40 years) with ultra–high-risk solid tumors who have achieved at least stable disease after their most recent therapy and can start within 12 weeks. Includes strata such as neuroblastoma, metastatic Ewing sarcoma, osteosarcoma, high-risk rhabdomyosarcoma, DSRCT, and other high-risk sarcomas; single-arm, compared to historical controls.

ClinicalTrials.gov ID: NCT05135975

A Phase 1/2, Open-Label, Multi-Center, First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of TPX-0005 in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements (TRIDENT-1)

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 adults and adolescents with advanced or metastatic solid tumors (including NSCLC) harboring ALK, ROS1, or NTRK1-3 gene rearrangements to receive repotrectinib, a next-generation oral tyrosine kinase inhibitor designed to overcome resistance mutations in these oncogenic fusions. Eligible patients may have received prior TKIs and may have asymptomatic CNS metastases.

ClinicalTrials.gov ID: NCT03093116

An Open-Label, Multicenter, First-in-Human, Dose-Escalation and Dose-Expansion, Phase 1/2 Study of BBI-355 and BBI-355 in Combination with Select Targeted Therapies in Subjects with Locally Advanced or Metastatic Solid Tumors with Oncogene Amplifications

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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.

HealthScout AI summary: Adults with locally advanced or metastatic solid tumors harboring oncogene amplifications who have progressed on or are ineligible for standard therapies may receive oral BBI-355, a selective CHK1 inhibitor, either as monotherapy or combined with erlotinib (EGFR inhibitor) or futibatinib (FGFR inhibitor) in cohorts defined by specific gene amplifications. Key exclusions include certain oncogenic mutations, prior targeted therapies, CNS involvement, and serious comorbidities.

ClinicalTrials.gov ID: NCT05827614

A Phase 1/1b First-in-Human, Open Label, Dose Escalation and Cohort Expansion Study of MGC026 in Participants With Advanced Solid Tumors

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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.

HealthScout AI summary: This trial enrolls adults with unresectable, locally advanced or metastatic solid tumors—including a wide range such as head and neck, lung, bladder, prostate, breast, colorectal, and others—who have progressed on or are intolerant to standard therapies. Patients receive MGC026, a B7-H3-targeted antibody-drug conjugate delivering a topoisomerase I inhibitor (exatecan), with cohorts in both dose escalation and expansion phases.

ClinicalTrials.gov ID: NCT06242470

A Phase 1, Open-label, Multicenter, Dose-escalation and Cohort Expansion Study of OKN4395, a Triple Antagonist of EP2, EP4, and DP1 Prostanoid Receptors, as Monotherapy and in Combination With Pembrolizumab, in Patients With Advanced Solid Tumors

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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.

HealthScout AI summary: This trial enrolls adults with advanced or metastatic solid tumors linked to COX2-mediated immunosuppression who have exhausted standard therapies, including specific expansion cohorts for sarcoma, pancreatic cancer, NSCLC without driver mutations, microsatellite stable/low colorectal cancer, and head and neck squamous cell carcinoma. Patients receive OKN4395, an oral triple antagonist of EP2, EP4, and DP1 prostanoid receptors, as monotherapy or in combination with pembrolizumab.

ClinicalTrials.gov ID: NCT06789172

Phase Ib/IIa Trial of Single Protein Encapsulated Doxorubicin, SPEDOX-6 in Advanced Malignancies

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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.

HealthScout AI summary: Eligible patients are adults with advanced, refractory solid tumors (including soft-tissue sarcoma, triple-negative breast cancer, NSCLC, cervical cancer, ovarian cancer, or KRAS-mutant pancreatic ductal adenocarcinoma), who have not previously received anthracyclines. The trial investigates Spedox-6, a novel human serum albumin-encapsulated doxorubicin formulation designed to enhance tumor delivery and reduce cardiotoxicity, given IV every 21 days at escalating doses (with filgrastim support at higher doses).

ClinicalTrials.gov ID: NCT07064018