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.
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.
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.
Parallel
bexmarilimab
DrugRP2D of bexmarilimab administered as IV infusion on D1 of 21-day cycle for 6 cycles.
Doxorubicin
Drug75 mg/m2 doxorubicin administered as IV infusion on D1 of 21-day cycle for 6 cycles.
Phase Ib: MTD and RP2D
The MTD and RP2D of bexmarilimab when used in combination with doxorubicin will be reported based upon evaluation of dose-limiting toxicities (DLTs) and adverse events (AEs) and other available data from secondary endpoints.
Phase II: PFS
PFS, defined as the period from treatment randomization to the first occurrence of disease progression or death from any cause, whichever occurs first, as determined locally by the Investigator using RECIST v1.1.
Phase Ib: 6-months PFS
PFS rate at 6 months (6-month PFS), defined as the rate of participants with absence of disease progression or death from any cause after the treatment initiation, as determined locally by the investigator using RECIST v.1.1.
ORR
ORR, defined as the rate of participants with complete response (CR) or partial response (PR), as determined locally by the investigator using RECIST v.1.1.
CBR
CBR, defined as the rate of participants with objective response (CR or PR), or stable disease for at least 24 weeks, as determined locally by the investigator using RECIST v.1.1.
TTR
TTR, defined as the period from treatment randomization to the first objective tumor response (tumor shrinkage of ≥ 30%) observed for participants who achieved a CR or PR, as determined locally by the investigator using RECIST v.1.1.
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MedSIR
Lead sponsor
Faron Pharmaceuticals Ltd
Collaborator
