Clinical Trials for Sarcoma

A Phase 2 Study to Evaluate the Efficacy and Safety of Adoptive Transfer of Autologous Tumor Infiltrating Lymphocytes in Patients With Advanced Solid Cancers

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: Adults with advanced, unresectable or metastatic solid tumors across multiple cohorts (e.g., gastric/EGJ, colorectal, pancreatic, sarcoma, mesothelioma, neuroendocrine, cutaneous/anal SCC, Merkel cell, MMR‑deficient/MSI cancers) after standard therapy, ECOG 0–1; stable small brain mets allowed. Treatment is autologous tumor-infiltrating lymphocyte (TIL) therapy (tumor harvest → ex vivo expansion) after cyclophosphamide/fludarabine lymphodepletion, followed by high-dose aldesleukin (IL-2) to support T-cell expansion; single course with option for a second.

ClinicalTrials.gov ID: NCT03935893

Phase I/ II Study of Pulmonary Suffusion to Control Minimal Residual Disease in Resectable or Ablatable Sarcoma or Colorectal Pulmonary Metastases

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: Adults with resectable or ablatable pulmonary metastases from soft tissue sarcoma, osteosarcoma, or colorectal cancer undergo regional isolated lung perfusion (“pulmonary suffusion”) with cisplatin followed by complete local control (metastasectomy/ablation), aiming to reduce intrapulmonary recurrence while limiting systemic toxicity. Eligible patients have ECOG 0–2 and adequate pulmonary function; bilateral disease may allow within-patient comparison of suffused vs non-suffused lungs.

ClinicalTrials.gov ID: NCT03965234

Ex-Vivo Expanded Allogeneic NK Cells for the Treatment of Solid Tumors of Pediatric Origin in Children and Young Adults

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: Children and young adults with relapsed/refractory pediatric-type solid tumors (non-CNS) receive cyclophosphamide/etoposide lymphodepletion followed by a single infusion of ex vivo expanded, cord blood–derived allogeneic NK cells (4–6/6 HLA-matched donor). The NK cells are activated to enhance MHC-unrestricted cytotoxicity (via natural cytotoxicity receptors and ADCC) to assess safety, dosing, persistence, and preliminary antitumor activity.

ClinicalTrials.gov ID: NCT03420963

A Phase I Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Clinical Activity of RO7673396 as a Single Agent and in Combination With Other Anticancer Therapies in Patients With Advanced Solid Tumors Harboring RAS Mutation(s)

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 incurable, advanced solid tumors harboring confirmed RAS mutations (KRAS/NRAS/HRAS), ECOG 0–1, and measurable disease receive RO7673396 (RG6505), an investigational small‑molecule RAS‑pathway inhibitor with potential pan‑RAS activity, as monotherapy in dose escalation and expansion. Excludes active/untreated CNS metastases and significant GI/liver issues; endpoints include safety, DLTs, PK, and preliminary efficacy (ORR by RECIST).

ClinicalTrials.gov ID: NCT06884618

Single-arm, Open-label, Phase 1b/2 Trial of Nivolumab Therapy Following Partially HLA Mismatched (Haploidentical) Bone Marrow Transplant in Children and Young Adults With High Risk, Recurrent or Refractory Sarcomas

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: Children, adolescents, and young adults (12 months–50 years) with high-risk, recurrent, or refractory sarcomas (and select poor-prognosis solid tumors) who are ≥day +120 after reduced-intensity haploidentical bone marrow transplant with PTCy receive post-transplant nivolumab. Nivolumab is a PD-1–blocking monoclonal antibody given IV (weight/flat dosing) for up to 24 cycles to enhance donor T‑cell antitumor activity while monitoring for GVHD and immune-related toxicities.

ClinicalTrials.gov ID: NCT03465592

Phase I Study of HER2 Chimeric Antigen Receptor (CAR) T Cells in Combination With Checkpoint Blockade in Patients With Advanced Sarcoma (HEROS 3.0)

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: Pediatric, adolescent, and young adult patients (1–25 years) with recurrent/progressive HER2‑positive sarcoma (≥1+ by IHC) after prior systemic therapy receive autologous HER2‑targeted second‑generation (CD28ζ) CAR T cells after cyclophosphamide/fludarabine lymphodepletion, followed about a week later by PD‑1 blockade with pembrolizumab (q3w) or nivolumab (q2w), with option for repeat CAR T infusions. Excludes significant autoimmune disease, active infection, bulky disease, prior severe Cy/Flu or checkpoint reactions, and major cardiopulmonary contraindications.

ClinicalTrials.gov ID: NCT04995003

A Phase 1, Two-Part, Multicenter, Open-Label First in Human Study of Anti-GD2 Antibody Drug Conjugate M3554 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: Adults with ECOG 0–1 and either advanced, unresectable/metastatic soft tissue sarcoma after at least one prior metastatic-line (including anthracycline) or IDH‑wildtype glioblastoma after first-line chemoradiation are eligible. Investigational therapy is M3554, an anti‑GD2 antibody–drug conjugate delivering the topoisomerase I inhibitor exatecan via a cleavable linker, given as monotherapy in dose escalation/expansion.

ClinicalTrials.gov ID: NCT06641908

A Phase 1/2a, Open-Label Study of Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SA53-OS, an MDM2 Inhibitor, in Patients With Locally Advanced or Metastatic p53 Wild-Type 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: Adults with refractory locally advanced/metastatic TP53 (p53) wild-type solid tumors (Phase 1 also allows relapsed/refractory non-Hodgkin lymphoma) receive SA53-OS, an oral small-molecule MDM2 inhibitor designed to reactivate wild-type p53. Phase 2a expands to dedifferentiated liposarcoma with MDM2 amplification and other TP53 wild-type solid tumors, with SA53-OS given 3 days every 3 weeks at the RP2D.

ClinicalTrials.gov ID: NCT06578624

A Phase II Trial of Reduced Intensity Conditioning and Partially HLA-mismatched (HLA-haploidentical) Related Donor Bone Marrow Transplantation for High-risk Solid Tumors

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: Children and adults (1–50 years) with very high-risk solid tumors (e.g., refractory neuroblastoma, stage 4 rhabdomyosarcoma, metastatic Ewing sarcoma, osteosarcoma with unresectable/extrapulmonary mets, desmoplastic small round cell tumor) undergo reduced-intensity conditioning (fludarabine/melphalan/200 cGy TBI) followed by T cell–replete haploidentical bone marrow transplant. Post-transplant cyclophosphamide is used for GVHD prophylaxis with a shortened tacrolimus course (to day +90) plus mycophenolate, aiming to enhance graft-versus-tumor while monitoring GVHD and non-relapse mortality.

ClinicalTrials.gov ID: NCT01804634

A Phase I Trial of CRD3874-SI, a STING Agonist, in Patients With Advanced/Metastatic Malignant 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: Adults with advanced/metastatic solid tumors after ≥1 prior therapy, with dose expansion focused on anti–PD-1/PD-L1–refractory or –progressed sarcoma subtypes (UPS/MFS, angiosarcoma, bone sarcoma) and Merkel cell carcinoma; ECOG 0–1 required. Patients receive weekly intravenous CRD3874-SI, an investigational small‑molecule allosteric STING agonist designed to enhance cGAMP-mediated type I interferon signaling, with 3+3 dose escalation to RP2D followed by expansion.

ClinicalTrials.gov ID: NCT06021626