Clinical Trials for Sarcoma

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.

TrialFetch 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.

TrialFetch 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.

TrialFetch 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.

TrialFetch 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.

TrialFetch 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.

TrialFetch 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.

TrialFetch 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

A Phase I/II, Dose-escalation and Dose-optimization Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of MT-4561 in Patients With Various Advanced Solid Tumors and to Evaluate Effect of MT-4561 on Pharmacokinetics of Oral Midazolam

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—including HNSCC, NSCLC, GI, GU, gynecologic, sarcoma, neuroendocrine, and NUT carcinoma—who have measurable disease and good performance status, to evaluate the intravenous BRD4 degrader MT-4561 administered weekly. MT-4561 is a novel agent targeting BRD4 for ubiquitin-mediated degradation and is being assessed primarily for safety and initial efficacy in this biomarker-unselected population.

ClinicalTrials.gov ID: NCT06943521

Phase 1 Study of X-PACT (X-ray Psoralen Activated Cancer Therapy) for Intra-tumoral Injection of Superficial Tumors in Patients With Advanced Head and Neck Cancer, Breast Cancer, Soft Tissue Sarcoma or 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.

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, superficial, and injectable head and neck cancer, breast cancer, soft tissue sarcoma, or melanoma that has progressed on or is ineligible for standard therapy. Patients receive intra-tumoral X-PACT, a novel approach using methoxsalen and a phosphor device activated by local X-ray to induce tumor cell death.

ClinicalTrials.gov ID: NCT04389281

A Phase 1, Open-Label, Dose-Escalation and Expansion Study of AGX101, a TM4SF1 Directed Antibody Drug Conjugate in Patients With Unresectable, Locally Advanced, or Metastatic 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.

TrialFetch AI summary: Eligible patients are adults with unresectable, locally advanced, or metastatic solid tumors who have exhausted standard therapies, good performance status (ECOG 0-1), and adequate organ function. The investigational agent is AGX101, a TM4SF1-targeted antibody-drug conjugate delivering a maytansinoid payload to tumor and tumor vasculature cells.

ClinicalTrials.gov ID: NCT06440005