Clinical Trials for Sarcoma

A Phase 1/2 Single-Center Trial Combining Venetoclax With G-CSF, Cladribine, Cytarabine, and Mitoxantrone (CLAG-M) for Patients With AML and High-Grade Myeloid Neoplasms

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 AML or high-grade myeloid neoplasms (≥10% blasts), including newly diagnosed adverse-risk disease (ELN 2022) and relapsed/refractory AML in phase I, receive intensive CLAG-M chemotherapy combined with venetoclax, an oral BCL‑2 inhibitor that promotes apoptosis. Induction includes G-CSF, cladribine, cytarabine, mitoxantrone plus venetoclax, with consolidation using CLAG (no mitoxantrone) plus venetoclax; key exclusions include APL, CML blast crisis, active CNS disease, uncontrolled infection, and need for strong CYP3A inhibitors (voriconazole allowed).

ClinicalTrials.gov ID: NCT04797767

A Phase 1/2, Open-Label, Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity Study of Repotrectinib in Pediatric and Young Adult Subjects With Advanced or Metastatic Malignancies Harboring ALK, ROS1, NTRK1-3 Alterations

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: Open-label, single-arm study of oral repotrectinib, a next-generation macrocyclic TKI targeting ROS1, ALK, and TRK (NTRK1/2/3) with CNS penetration, in children <12 with ALK/ROS1/NTRK-altered advanced malignancies (dose-finding) and adolescents/young adults (12–25) with NTRK fusion–positive (TKI-naïve or pretreated) or ROS1-altered advanced solid tumors/ALCL. Eligible patients require measurable disease and prior progression/intolerance or lack of standard therapy; endpoints include safety/PK in pediatrics and confirmed ORR by BICR in expansion cohorts.

ClinicalTrials.gov ID: NCT04094610

TAGGED: A Phase 2 Study Using Low Dose/Metronomic Trabectedin, Gemcitabine, and Dacarbazine as 2nd/3rd/4th Line Therapy for Advanced Soft Tissue Sarcoma

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 previously treated, locally advanced or metastatic leiomyosarcoma receive a metronomic regimen of trabectedin (DNA minor-groove binder affecting transcription/repair), gemcitabine (nucleoside analog), and dacarbazine (alkylating agent) on Days 1 and 8 of 21-day cycles. Single-arm study aims to assess disease control and tolerability as later-line therapy, treating until progression or toxicity for up to 1 year.

ClinicalTrials.gov ID: NCT04535271

Phase I Trial of TURALIO (Pexidartinib, PLX3397) in Children and Young Adults With Refractory Leukemias and Refractory Solid Tumors Including Neurofibromatosis Type 1 (NF1) Associated Plexiform Neurofibromas (PN) and Tenosynovial Giant Cell Tumor (TGCT)

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: Enrolls children and young adults (3–35 years) with refractory/recurrent solid tumors (including CNS tumors, NF1-associated plexiform neurofibromas/MPNST, TGCT) or refractory AML/ALL to receive oral pexidartinib daily in 28-day cycles. Pexidartinib is a small-molecule inhibitor of CSF1R (with KIT and FLT3 activity) targeting tumor-associated macrophages and relevant oncogenic kinases.

ClinicalTrials.gov ID: NCT02390752

Open-Label, Multicenter, Phase 1 Study to Assess the Safety of P-CD19CD20-ALLO1 in Subjects With Selected Relapsed/Refractory B Cell 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: Adults with relapsed/refractory aggressive B‑cell lymphomas (DLBCL, high‑grade B‑cell lymphoma, PMBCL, transformed FL/FL3B) after prior anti‑CD20/anthracycline therapy—including those previously treated with CD19‑directed therapy or autologous CAR‑T—receive a single infusion of P‑CD19CD20‑ALLO1 after cyclophosphamide/fludarabine lymphodepletion. P‑CD19CD20‑ALLO1 is an off‑the‑shelf allogeneic dual‑target (CD19/CD20) CAR‑T engineered to reduce alloreactivity and HLA‑I expression with an inducible rimiducid safety switch.

ClinicalTrials.gov ID: NCT06014762

A First-in-human, Phase I, Multi-center, Open-label, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Evidence of Antitumor Activity of IDOV-Immune in Adult 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: Adults with advanced solid tumors refractory to standard therapy (ECOG 0–1, measurable disease) receive a single intravenous infusion of IDOV-Immune (VM-002), a genetically engineered oncolytic vaccinia virus designed for tumor-selective replication and lysis with immune-stimulating transgenes to enhance antitumor immunity. Key exclusions include prior oncolytic virus therapy, recent vaccinia/smallpox vaccination, active autoimmune disease requiring systemic therapy, significant cardiopulmonary disease, uncontrolled infection, and unstable/untreated CNS metastases.

ClinicalTrials.gov ID: NCT06910657

A First-In-Human Phase 1 Trial of T-Cell Membrane-Anchored Tumor Targeted Il12 (Attil12)- T-Cell Therapy in Subjects With Advanced/Metastatic Soft Tissue and Bone 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: Adolescents and adults (≥12) with advanced/metastatic soft tissue or bone sarcoma after ≥1 prior systemic therapy (ECOG 0–1); dose‑expansion focuses on unresectable recurrent/metastatic osteosarcoma. Treatment is cyclophosphamide lymphodepletion followed by a single infusion of autologous T cells engineered to display tumor‑targeted, membrane‑anchored IL‑12 that binds cell‑surface vimentin to localize IL‑12 activity and boost intratumoral IFN‑γ–mediated immunity.

ClinicalTrials.gov ID: NCT05621668

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

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

A Phase 1/2a, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of BMS-986523 As Monotherapy and in Combination With Anti-Cancer Agents in Participants 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: Adults with locally advanced unresectable or metastatic solid tumors harboring a KRAS alteration (mutation or amplification) who have progressed on, are ineligible for, or declined standard-of-care therapy (Arm D additionally requires PD-L1 TPS ≥50%; excludes untreated CNS metastases and ILD/pneumonitis). Participants receive the first-in-human agent BMS-986523 (target/mechanism not publicly described) as monotherapy or combined with pembrolizumab (anti–PD-1), cetuximab (anti-EGFR), or gemcitabine plus nab-paclitaxel.

ClinicalTrials.gov ID: NCT07223047

A Randomized Phase I/II Study of Talazoparib or Temozolomide in Combination With Onivyde in Children With Recurrent Solid Malignancies and Ewing Sarcoma

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: Enrolls children/AYA age >12 months to <30 years with recurrent/refractory non-CNS solid tumors (dose-finding/expansion, including an HRR-altered cohort) and randomizes patients with first-relapse, EWSR1-rearranged Ewing sarcoma to compare efficacy. Treatment is nanoliposomal irinotecan (Onivyde; topoisomerase I–mediated DNA damage) on days 1 and 8 of 21-day cycles combined with either talazoparib (PARP1/2 inhibitor with PARP-trapping) or temozolomide (oral DNA-alkylating agent).

ClinicalTrials.gov ID: NCT04901702