Clinical Trials for Sarcoma

A Multicenter, Open-label, Interventional Phase I Trial to Determine the Dose and Evaluate the Pharmacokinetics (PK) and Safety of Lutetium Lu 177 Edotreotide Targeted Radiopharmaceutical Therapy (RPT) as Monotherapy or Following Standard of Care (SoC) for the Treatment of Somatostatin Receptor-positive Tumors in the Pediatric Population (KinLET).

Active drug

Investigational drug(s) in this trial have shown anticancer activity 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 and adolescents aged 2 to <18 years with relapsed/progressive/refractory somatostatin receptor–positive malignancies (e.g., neuroendocrine tumors, CNS tumors, lymphoma, other solid tumors) after ≥1 prior therapy, requiring SSTR expression by IHC and uptake on SSTR PET/SPECT greater than liver. Patients receive IV lutetium Lu 177 edotreotide (177Lu-DOTATOC) peptide receptor radionuclide therapy—a radiolabeled somatostatin analog targeting SSTR2 to deliver localized beta radiation—every 8 weeks for up to 6 doses (with amino acids for renal protection), either as monotherapy or after standard-of-care therapy.

ClinicalTrials.gov ID: NCT06441331

Metformin Hydrochloride in Combination With Standard of Care Systemic Therapy in Previously Untreated Advanced Unresectable or Metastatic Soft Tissue Sarcoma

Low burden on patient

The trial has a low burden on patients. An example would be a trial testing an oral drug, with scans every 12 weeks which would be similar to standard of care.

TrialFetch AI summary: Adults with previously untreated advanced unresectable or metastatic intermediate/high-grade soft tissue sarcoma receive physician-selected first-line systemic therapy plus oral extended-release metformin. Metformin is a biguanide with proposed anticancer activity via reduced insulin/IGF signaling and AMPK activation with downstream mTOR pathway inhibition.

ClinicalTrials.gov ID: NCT07291297

Study of Tegavivint, a Transducin Beta-like Protein 1 (TBL1) Inhibitor, With Gemcitabine in Patients With Relapsed or Refractory Osteosarcoma

Active drug

Investigational drug(s) in this trial have shown anticancer activity 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: Open-label dose-escalation/expansion study for patients with relapsed or refractory osteosarcoma after intensive frontline chemotherapy, with measurable/evaluable disease or selected patients rendered NED after pulmonary metastasectomy. All patients receive IV tegavivint, a TBL1 inhibitor that disrupts TBL1–β-catenin interaction and suppresses Wnt/β-catenin signaling, plus IV gemcitabine in 21-day cycles.

ClinicalTrials.gov ID: NCT07144254

Phase II Study of Recombinant Glycosylated Human Interleukin-7 (CYT107) for the Treatment of Kaposi Sarcoma in Participants With HIV and Immune Non-response (REGIMEN-KS HIV)

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

TrialFetch AI summary: Adults with HIV-associated Kaposi sarcoma and persistent CD4 lymphopenia (CD4 ≤350 cells/mcL) despite virologically suppressed antiretroviral therapy, with measurable cutaneous disease and either treatment-naive or previously treated KS, receive intramuscular CYT107 weekly for up to 4 weeks with possible retreatment. CYT107 is investigational glycosylated recombinant human IL-7 intended to restore T-cell immunity via IL-7 receptor signaling and improve immune control of KSHV.

ClinicalTrials.gov ID: NCT07308886

A Phase 1 Study of the Safety and Efficacy of CRX100 as Monotherapy and in Combination With Pembrolizumab in Advanced Solid Malignancies

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

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 targets adult patients with advanced solid malignancies and evaluates the safety and efficacy of CRX100, an investigational immunotherapy combining autologous T cells and oncolytic vaccinia virus, as monotherapy and in combination with Pembrolizumab.

ClinicalTrials.gov ID: NCT04282044

A Phase 1/2, Open-label, Dose-escalation, and Expansion Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Therapeutic Activity of GI-101 As a Single Agent and in Combination with Pembrolizumab, Lenvatinib or Local Radiotherapy in Patients with Advanced or Metastatic Solid Tumors (Keynote B59)

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

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 involves adult patients with advanced or metastatic solid tumors and evaluates the safety and therapeutic activity of GI-101, a bispecific fusion protein targeting CTLA-4 and the IL-2 pathway, as a single agent and in combination with pembrolizumab, lenvatinib, or radiotherapy.

ClinicalTrials.gov ID: NCT04977453

A Pilot Study of Spatially Fractionated Radiation Therapy in Patients with Extra-Cranial Soft Tissue Metastases

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: This trial enrolls adults with advanced or metastatic solid tumors and at least two extracranial soft tissue metastases (one ≥4 cm) requiring palliative radiation, comparing lattice radiation therapy (LRT)—a spatially fractionated radiotherapy technique that may enhance immune effects—to standard SBRT, with each patient receiving both treatments at different sites.

ClinicalTrials.gov ID: NCT05837767

A Phase 1, Open Label, Dose-Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics and Initial Therapeutic Activity of AVA6000, a Novel FAP-activated Doxorubicin Prodrug Administered Intravenously in Patients With Locally Advanced or Metastatic Selected Solid Tumours

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

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: Eligible patients are adults with locally advanced or metastatic FAP-positive solid tumors, including high-grade soft-tissue sarcoma, salivary gland carcinoma, and triple-negative breast cancer, who have progressed on or are ineligible for standard therapies. Patients receive intravenous AVA6000, a FAP-activated doxorubicin prodrug designed to deliver doxorubicin selectively to tumor tissue in order to minimize systemic toxicity.

ClinicalTrials.gov ID: NCT04969835

A Phase 1 Multiple Expansion Cohort Trial of MRTX1719 in Patients With Advanced Solid Tumors With Homozygous MTAP Deletion

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

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: Adults with unresectable or metastatic solid tumors harboring homozygous MTAP deletion (biopsy-amenable, ECOG 0-1) are eligible to receive MRTX1719, a selective PRMT5 inhibitor targeting the PRMT5-MTA complex, as monotherapy or in combination with standard therapies in expansion cohorts. Prior PRMT5 or MAT2A inhibitor therapy is excluded.

ClinicalTrials.gov ID: NCT05245500

Locally AblatiVe TherApy in OLigO-pRogressive SOlid TUmorS (VALOROUS)

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: This trial enrolls adults with various solid tumors (including breast, gynecologic, head and neck cancers, and sarcomas) who have oligo-progressive disease (≤5 progressing metastatic lesions) despite ongoing benefit from systemic therapy; patients continue their current systemic treatment and receive locally ablative therapy (via stereotactic ablative radiotherapy or image-guided ablation) to all progressing sites.

ClinicalTrials.gov ID: NCT06103669