Clinical Trials for Sarcoma

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.

HealthScout 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

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.

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: 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.

HealthScout 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

A Phase 1 Dose-Escalation Study of SLV-154 in Subjects With 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.

HealthScout AI summary: Eligible patients are adults with metastatic squamous cell carcinoma of the head and neck, non-small cell or small cell lung cancer, breast, cervical, endometrial, ovarian, urothelial, sarcoma, or thyroid cancer that has progressed after standard therapies; participants must have measurable disease, adequate organ function, and be willing to undergo tumor biopsy. Patients will receive intravenous SLV-154 (mechanism and target undisclosed) in 3-week cycles at escalating doses to determine safety and dosing parameters.

ClinicalTrials.gov ID: NCT06771219

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

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

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.

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 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

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.

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 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

A Phase I Study of Safety, Pharmacokinetic and Efficacy of Orally Administered APG-5918 in Patients With Advanced Solid Tumors or Hematologic 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.

HealthScout AI summary: Adults with advanced/metastatic solid tumors or relapsed/refractory non-Hodgkin’s lymphoma (ECOG 0–2) who have exhausted standard options receive once-daily oral APG-5918, an EED inhibitor that allosterically disrupts PRC2 to deplete H3K27me3. Expansion focuses on molecular subsets including EZH2-mutant B‑cell lymphomas, SMARCB1-deficient sarcomas (epithelioid preferred), and castration‑resistant prostate cancer; treated/stable brain mets allowed.

ClinicalTrials.gov ID: NCT05415098

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

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.

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: 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