NCT07460986

A PHASE IB/II STUDY TO EVALUATE SAFETY AND EFFICACY OF BEXMARILIMAB IN COMBINATION WITH DOXORUBICIN IN METASTATIC SOFT-TISSUE SARCOMA

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 278 (estimated)
• Sponsor: MedSIR · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial will Study a type of sarcoma defined metastatic soft-tissue sarcoma (STS). Participants will be treated with bexmarilimab, a CLEVER-1 antibody plus doxorubicin, a chemotherapy. The main purpose of the Study is to analyze the safety (to find out how safe or toxic a treatment is to appropriately manage the risks) and efficacy (to find out how effective a treatment is) of bexmarilimab combined with doxorubicin in participants who have STS.

Detailed description

The main purpose of the Study is to analyze the safety and efficacy of bexmarilimab combined with doxorubicin in participants who have STS. The safety of bexmarilimab and doxorubicin will be determined by assessing the safe dose of bexmarilimab when administered with doxorubicin, defined as the dose-limiting toxicities and adverse events. Bexmarilimab plus doxorubicin treatment efficacy will be determined by assessing the PFS, defined as the period from treatment initiation/randomization to the first occurrence of disease progression or death from any cause.

Conditions

• Sarcoma of Soft Tissue

Interventions

Type	Name	Description
DRUG	bexmarilimab	RP2D of bexmarilimab administered as IV infusion on D1 of 21-day cycle for 6 cycles.
DRUG	Doxorubicin	75 mg/m2 doxorubicin administered as IV infusion on D1 of 21-day cycle for 6 cycles.

Timeline

• Start date: 2026-07-01
• Primary completion: 2028-07-01
• Completion: 2028-10-01
• First posted: 2026-03-10
• Last updated: 2026-03-10