Clinical Trials for Sarcoma

A Phase II Study of ASTX727 in Patients With PRC2 Loss Malignant Peripheral Nerve Sheath Tumor (MPNST)

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 PRC2-loss MPNST (H3K27me2/3 loss or EED/SUZ12/EZH2 alterations) after prior therapy receive oral ASTX727 (cedazuridine/decitabine) days 1–5 of 21-day cycles with pegfilgrastim support. ASTX727 combines a cytidine deaminase inhibitor to boost exposure of decitabine, a DNA hypomethylating agent that inhibits DNMT, aiming to exploit epigenetic vulnerabilities in PRC2-deficient tumors.

ClinicalTrials.gov ID: NCT04872543

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

Phase 1 Clinical Trial of ONC201 and Atezolizumab in Obesity-Driven Endometrial Cancer

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 metastatic or recurrent endometrial cancer (multiple histologies) after ≥1 prior cytotoxic line, ECOG 0–2, receive atezolizumab (PD‑L1 inhibitor) plus ONC201/dordaviprone, an investigational DRD2 antagonist and ClpP agonist that activates the integrated stress response to promote tumor apoptosis and immunogenicity. Nonrandomized dose-finding with expansion; cohorts stratified by obesity (BMI >30 vs ≤29.9); prior PD-(L)1 or ONC201 not allowed.

ClinicalTrials.gov ID: NCT05542407

Metastatic Ewing's Trial Testing Schedule Enhancement to Improve Outcomes

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: 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.

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: 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

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 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 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)

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.

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