Clinical Trials for Sarcoma

A Phase I Study of Autologous Activated T-Cells Expressing a 2nd Generation GD2 Chimeric Antigen Receptor, IL-15, and iCaspase9 Safety Switch Administered To Patients With Relapsed/Refractory Neuroblastoma or Relapsed/Refractory Osteosarcoma

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.

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.

TrialFetch AI summary: For pediatric and adult patients with relapsed/refractory high-risk neuroblastoma/ganglioneuroblastoma or osteosarcoma, after standard therapies. Patients receive lymphodepleting cyclophosphamide/fludarabine followed by a single infusion of autologous GD2-directed CAR T cells engineered to co-express IL-15 (to enhance persistence/function) and an inducible caspase-9 safety switch.

ClinicalTrials.gov ID: NCT03721068

A Phase 1 Open-Label, Dose-Escalation and Dose-Expansion Study to Investigate the Safety, Pharmacokinetics, and Anti-Tumor Activity of IACS-6274 as Monotherapy and in Combination in Patients With Advanced 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.

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.

TrialFetch AI summary: Adults with advanced, refractory solid tumors (ECOG 0–1) lacking standard options receive the oral GLS1 inhibitor IACS-6274 either as monotherapy or combined with bevacizumab plus weekly paclitaxel or with the AKT inhibitor capivasertib. Biomarker-enriched cohorts include platinum-resistant high-grade serous ovarian cancer with low ASNS and tumors (including NSCLC) harboring KEAP1/NFE2L2/STK11/NF1 or PI3K/AKT/PTEN pathway alterations.

ClinicalTrials.gov ID: NCT05039801

Pilot Pharmacokinetic Study of VAL-413 (Orotecan®) in Patients With Recurrent Pediatric 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.

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.

TrialFetch AI summary: Enrolling children, adolescents, and young adults (1–≤30 years) with recurrent/refractory solid or CNS tumors lacking curative options, including those previously exposed to irinotecan/temozolomide if not refractory. Patients receive a flavored oral irinotecan formulation (VAL-413, prodrug converted to SN-38 topoisomerase I inhibitor) plus oral temozolomide in 5-day, 21-day cycles, with a cycle 1 PK comparison dose of orally administered IV irinotecan solution.

ClinicalTrials.gov ID: NCT04337177

A Multi-Institution Study of TGFβ Imprinted, Ex Vivo Expanded Universal Donor NK Cell Infusions as Adoptive Immunotherapy in Combination With Gemcitabine and Docetaxel in Patients With Relapsed or Refractory Pediatric Bone and Soft Tissue

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.

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.

TrialFetch AI summary: Relapsed/refractory pediatric and young adult sarcomas (osteosarcoma, Ewing, rhabdomyosarcoma, non-rhabdomyosarcoma soft tissue; ages 2–40) receive gemcitabine/docetaxel plus off‑the‑shelf, ex vivo expanded TGFβ‑imprinted universal donor NK cells designed to resist TGFβ-mediated suppression in the tumor microenvironment. NK infusions are given on day 12 of 21‑day cycles (up to 6 NK doses within 8 chemotherapy cycles) with safety and 6‑month PFS assessed.

ClinicalTrials.gov ID: NCT05634369

A First-In-Human Phase I, Open Label, Safety and Tolerability Study of Escalating Multiple Doses of Intratumoral MQ710, a Multi-Transgene Expressing Modified Vaccinia Virus Ankara-Based Virotherapy, Alone and in Combination With the Systemic Checkpoint Inhibitor Pembrolizumab in 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.

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.

TrialFetch AI summary: Enrolls adults with relapsed/refractory or treatment-ineligible advanced/metastatic solid tumors (ECOG 0–1) who have at least two injectable lesions, with emphasis on cutaneous and head/neck cancers (e.g., cSCC, BCC, melanoma, Merkel cell carcinoma, HNSCC) including anti–PD-1–refractory cohorts. Patients receive intratumoral MQ710/MQ719, a non-replicating modified vaccinia Ankara virotherapy (E5R-deleted to enhance cGAS/STING signaling and engineered to express Flt3L and OX40L), given in escalating multi-dose schedules alone or combined with systemic pembrolizumab (PD-1 inhibitor).

ClinicalTrials.gov ID: NCT05859074

Novel RNA-lipid Particle (RNA-LP) Vaccine for Anti-PD-1 Antibody Therapy Sensitization

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.

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.

TrialFetch AI summary: Adults with ECOG 0–2 melanoma (stage IIB–IV with progression on or within 6 months after adjuvant anti–PD-1, including select rare subtypes with metastatic immunotherapy failure) or unresectable stage II/III–IV soft tissue sarcoma with accessible measurable disease and early resistance/need to continue anti–PD-1 therapy are enrolled, requiring surgically obtainable tumor for vaccine manufacture. Patients receive an individualized autologous total tumor mRNA vaccine formulated in DOTAP lipid particles (IV 3-dose series) intended to enhance antigen presentation/innate activation and re-sensitize to checkpoint blockade, followed by continuation/resumption of anti–PD-1 per protocol.

ClinicalTrials.gov ID: NCT05264974