Clinical Trials for Sarcoma

A Phase 1/1B Study of ST-01156, a Small Molecule RBM39 Degrader, in Patients With Advanced Solid 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.

TrialFetch AI summary: Enrolls adults with metastatic or locally advanced unresectable solid tumors (ECOG ≤2; measurable/evaluable by RECIST) with biologic rationale for RBM39 degradation; adolescents ≥16 may enroll for Ewing sarcoma or other supported malignancies, and stable treated brain metastases are allowed. Patients receive oral ST-01156, a small-molecule molecular glue RBM39 degrader (RNA-binding/splicing factor), dosed once daily on a 5-days-on/2-days-off schedule in 28-day cycles with dose escalation to define MTD/RP2D and assess early antitumor activity.

ClinicalTrials.gov ID: NCT07197554

A Seamless Phase 1/2 Open-label Study to Evaluate the Safety, Determine the Maximum Tolerated Dose of Administered Activity, and Evaluate the Efficacy of the Therapeutic Radiopharmaceutical [Ac 225]-RTX-2358 in the Treatment of Relapsed or Refractory Sarcoma

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 adults (≥18) with relapsed/refractory, measurable soft tissue sarcoma after ≥1 prior systemic regimen (ECOG 0–1) whose tumors are FAP-PET–positive, this study treats with IV [Ac-225]RTX-2358, a fibroblast activation protein (FAP)–targeted actinium-225 alpha-emitting radiopharmaceutical delivering high–linear energy transfer cytotoxic radiation to the tumor microenvironment, dosed every 8 weeks for 4 cycles (up to 6 if benefiting). Patients also receive the investigational FAP-targeted PET imaging agent [Cu-64]LNTH-1363S for selection/imaging and dosimetry assessments.

ClinicalTrials.gov ID: NCT07156565

First in Human Phase 1 Study of AOH1996 in Patients With Refractory 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: This trial involves adult patients with refractory solid tumors unresponsive or declining standard treatments, evaluating the PCNA inhibitor AOH1996, which targets a cancer-specific variant to impair DNA replication and repair, dosed orally twice daily in a 28-day cycle.

ClinicalTrials.gov ID: NCT05227326

An Open-Label, Multiple-Dose, Dose-Escalation Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of VMD-928 in Subjects With Solid Tumors or Lymphoma

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: This trial enrolls adults with advanced solid tumors or lymphoma that are refractory to standard therapies, whose tumors overexpress TrkA or harbor an NTRK1 gene fusion, to receive oral VMD-928, a highly selective irreversible TrkA inhibitor that acts via allosteric dimerization and inactivation of the target. Key exclusions include significant comorbidities and impaired drug absorption.

ClinicalTrials.gov ID: NCT03556228

First-in-Human Phase I Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of Metarrestin (ML-246) in Subjects With Metastatic 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: This trial enrolls adults with metastatic solid tumors (such as pancreatic, colorectal, and breast cancers) who have progressed after standard therapies, as well as adolescents (12–17 years) with solid tumors lacking standard options (excluding rhabdomyosarcoma), to receive oral metarrestin, a first-in-class small molecule that targets the perinucleolar compartment to disrupt ribosome biogenesis and inhibit metastasis.

ClinicalTrials.gov ID: NCT04222413

Phase 1 Trial With GD2-SADA:177Lu-DOTA Drug Complex in Patients With Recurrent or Refractory Metastatic Solid Tumors Known to Express GD2, Including Small Cell Lung Cancer, High Risk Neuroblastoma, Sarcoma and Malignant Melanoma

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 adults (≥18; ≥16 for high-risk neuroblastoma or sarcoma) with measurable, GD2-positive recurrent/metastatic solid tumors (e.g., SCLC, high-risk neuroblastoma, sarcomas, melanoma) with ECOG 0–1 and adequate organ function. Two-step pretargeted radioimmunotherapy: IV GD2-SADA bispecific fusion protein (targets GD2; self-assembling/disassembling to enhance tumor avidity and renal clearance) followed after a set interval by 177Lu-DOTA to deliver beta radiation to tumor-retained antibody; dose-escalation with repeat cycles allowed.

ClinicalTrials.gov ID: NCT05130255

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