BENITIONSClinical Trial Intelligence

A Study of PRS-344/S095012 (PD-L1x4-1BB Bispecific Antibody) in Patients With Solid Tumors

Phase 1/2 Terminated NCT05159388

ConditionSolid Tumor
PhasePhase 1/2
SponsorServier Bio-Innovation LLC
StatusTerminated
Enrollment46 participants
InterventionsPRS-344/S095012
Start dateSep 8, 2021
Completion dateApr 1, 2025
Results postedJun 16, 2026

Summary

This is a first-in-human (FIH), phase 1/2, multi center, open-label, dose escalation and cohort expansion study designed to determine the safety and tolerability of PRS-344/S095012 in patients with advanced and/or metastatic solid tumors.

Safety Measurements: Number of Participants With at Least One DLT in the First 28-days of Treatment

28 days · Participants

PRS-344/S095012 12mg0 Participants
PRS-344/S095012 36mg1 Participants
PRS-344/S095012 60mg3 Participants
PRS-344/S095012 80mg1 Participants
PRS-344/S095012 36mg and Obinutuzumab3 Participants

Safety Measurements: Number of Participants With at Least One AE

Through study termination, approximately 3.5 years · Participants

PRS-344/S095012 12mg4 Participants
PRS-344/S095012 36mg9 Participants
PRS-344/S095012 60mg14 Participants
PRS-344/S095012 80mg6 Participants
PRS-344/S095012 36mg and Obinutuzumab12 Participants

Safety Measurements: Number of Participants With at Least One AE Leading to Treatment Discontinuation

Through study termination, approximately 3.5 years · Participants

PRS-344/S095012 12mg1 Participants
PRS-344/S095012 36mg4 Participants
PRS-344/S095012 60mg7 Participants
PRS-344/S095012 80mg2 Participants
PRS-344/S095012 36mg and Obinutuzumab7 Participants

Open in BENITIONS View on ClinicalTrials.gov

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