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

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedSIR

About this trial

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.

Eligibility criteria

Qualifiers

Participant, or legal representative (if applicable), must be capable to understand the purpose of the Study and have signed written informed consent form (ICF) prior to beginning specific protocol procedures.

Female or male participants ≥ 18 years of age at the time of signing ICF.

Histologically documented metastatic STS with no more than 3 lines of treatment.

Participant has not received doxorubicin, but doxorubicin could be indicated for metastatic disease as per institutional guidelines.

Disqualifiers

Participation in another clinical trial, interventional or observational, until the Study's safety visit. Note: participation in retrospective studies or data analysis is allowed.

Treatment with approved or investigational cancer therapy within 14 days prior to initiation of Study drug.

Prior treatment with anthracyclines for localized or advanced disease.

Prior treatment with immunocheckpoint inhibitors for localized or advanced disease.

Trial design

Treatments tested in this trial

  • bexmarilimab
  • Doxorubicin

Treatment groups

278 Participants
are divided into 4 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

MedSIR

Lead sponsor

Faron Pharmaceuticals Ltd

Collaborator