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NCT05159388 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by Servier Bio-Innovation.

Terminated
Registry status
Phase 1
Development phase
46
Enrollment target

NCT05159388: Clinical Trial Phase 1 study, sponsored by Servier Bio-Innovation.

NCT05159388 is a Phase 1 study that was terminated before completion, run by Servier Bio-Innovation. The registered enrollment target is 46 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05159388, a Phase 1 study, was terminated before completion, sponsored by Servier Bio-Innovation.

TERMINATED
Registry status
Phase 1
Development phase
46 participants
Enrollment target

Study 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.

Primary Outcome

Phase 1: Dose-limiting toxicities (DLTs) over the first 28-days of study treatment

Interventions

  • DRUG PRS-344/S095012

Trial Details

FieldValue
Enrollment Target 46 participants
Start Date 2021-09-08
Est. Completion 2025-04-01
Phase Phase 1
Servier Bio-Innovation

9 total trials

Why NCT05159388 stopped before completion

NCT05159388 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% lower).

The record links to 0 conditions, and to 1 intervention - of which PRS-344/S095012 is the first listed.

NCT05159388 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05159388 about?

NCT05159388 is a clinical study titled "A Study of PRS-344/S095012 (PD-L1x4-1BB Bispecific Antibody) in Patients With Solid Tumors". 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.

What is the current status of trial NCT05159388?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 46 participants. The study started on 2021-09-08. Estimated completion is 2025-04-01.

What interventions are being tested in trial NCT05159388?

The interventions under investigation include: PRS-344/S095012 (DRUG).

Who is sponsoring clinical trial NCT05159388?

This trial is sponsored by Servier Bio-Innovation, which has 9 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05159388's enrollment target sits among peer trials

46 1058th of 2000 higher than 935 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05159388, the US trial registry maintained by the National Library of Medicine. NCT05159388 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.