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Solid TumorPhase 1/2NCT05159388

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

A Phase 1/2 study testing PRS-344/S095012 in people with Solid Tumor, run by Servier Bio-Innovation LLC at 11 sites in 4 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumor
What is being tested?
PRS-344/S095012
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
11 sitesin 4 countries
Study dates
8 Sep 2021to 1 Apr 2025
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥18 years on the day the consent is signed.
  • Patients with histologically confirmed diagnosis of unresectable, locally advanced or metastatic solid tumor for which standard treatment options are not available, no longer effective, or not tolerated.
  • Patient should have a documented disease progression on prior therapy before entry into this study.
  • Patients must have at least one measurable target lesion as per RECIST 1.1.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Patient with no available archived material must have one or more tumor lesions amenable to biopsy.
  • Adequate organ function as assessed by laboratory tests within 7 days prior to pretreatment with obinutuzumab.
  • A female patient must use a highly effective method of birth control during study treatment and for 120 days after last dose of PRS-344/S095012, or 18 months after the last obinutuzumab infusion, whichever comes the latest.

Who cannot join

  • Patients with previously treated brain metastases may participate provided they are radiologically stable, clinically asymptomatic and are off immunosuppressive therapies for at least 4 weeks. Low dose of steroid <10 mg/day prednisone or equivalent) is allowed.
  • Patients who have received prior:
  • Small molecule inhibitors, and/or other similar investigational agent: ≤ 2 weeks or 5 half-lives, whichever is shorter.
  • Chemotherapy, other monoclonal antibodies, antibody-drug conjugates, or other similar experimental therapies: ≤3 weeks or 5 half-lives, whichever is shorter.
  • Radioimmunoconjugates or other similar experimental therapies ≤6 weeks or 5 half-lives, whichever is shorter.
  • Patients who have received 4-1BB agonists in the past.
Show all 9Show fewer
  • Patients who had a major surgery within 4 weeks prior to first administration of IMP.
  • History of progressive multifocal leukoencephalopathy.
  • Active tuberculosis requiring treatment within 3 years prior to the start of treatment or a suspicion of latent tuberculosis by the investigator.

Trial locations and contacts

11 sites in 4 countries.

11 sites in 4 countries

Australia3 sites

  • Chris O'Brian Lifehouse

    Camperdown

  • Cabrini Oncology Research

    Malvern, Victoria

  • The Queen Elizabeth Hospital

    Woodville South

Other trials in Australia

Belgium3 sites

  • Institute Jules Bordet

    Brussels

  • Universitair Ziekenhuis

    Edegem

  • U.Z. Gent Medical Oncology

    Ghent

Other trials in Belgium

Spain3 sites

  • Hospital Vall d'Hebron

    Barcelona

  • START

    Madrid, 28050

  • Hospital Universitario Gregorio

    Madrid

Other trials in Spain

United States2 sites

  • Carolina Bio Oncology

    Huntersville, North Carolina, 28078

  • NEXT Oncology

    San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: A First in Human Phase 1-2 Open-Label, Multicenter, Dose Escalation and Expansion Study of PRS-344/S095012 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.

Read the detailed description

The trial is an open-label, multi-center safety trial of PRS-344/S095012. The trial consists of two parts, a dose escalation part (phase 1, first-in-human (FIH) and an expansion part (phase 2)). The expansion part of the trial will be initiated once the optimal biological dose (OBD) has been determined. The study was terminated during phase 1 and thus, recruitment into phase 2 was not started.

Conditions
Solid Tumor
Being tested
PRS-344/S095012
Keywords
Solid Tumor = Phase 1/2, Open-label, Dose escalation, Metastatic, PRS-344, S095012, PRS-344/S095012, Anticalin protein, Bi-specific, 4-1BB, CD137, PD-L1
Medical subject headings
Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PRS-344/S095012Drug

    PRS-344/S095012 Monotherapy or with pretreatment by obinutuzumab

Study groups in NCT05159388
Study groupRoleWhat they receive
PRS-344/S095012ExperimentalPRS-344/S095012
Receives: Drug: PRS-344/S095012

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: 28 days

  2. Safety Measurements: Number of Participants With at Least One AE

    Phase 1: Adverse events (AEs), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0

    Measured: Through study termination, approximately 3.5 years

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

    Phase 1: Discontinuation of study treatment due to an AE

    Measured: Through study termination, approximately 3.5 years

Secondary outcomes (6)

  1. Mean PRS-344/S095012 Concentrations at the End of the Infusion

    Phase 1

    Measured: Cycle 1 Day 1 and Cycle 2 Day 1 (each cycle was 28 days)

  2. Mean PRS-344/S095012 Trough Concentrations (Ctrough)

    Phase 1

    Measured: Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Cycle 3 Day 1, Cycle 3 Day 15, Cycle 4 Day 1, Cycle 4 Day 15, Cycle 5 Day 1, Cycle 5 Day 15, Cycle 6 Day 1 (each cycle was up to 28 days)

  3. Number of Participants With at Least One Positive Anti-drug Antibody (ADA) Titer Result PRS-344/S095012

    Phase 1

    Measured: Through study termination, approximately 3.5 years

  4. Objective Response Rate (ORR)

    Phase 1: Defined as Complete Response (CR) plus Partial Response (PR), per investigator assessment

    Measured: Through study termination, approximately 3.5 years

  5. Best Overall Response (BOR)

    Phase 1: The best response across visits as; 1) partial response (PR): At least 2 PR or better (PR followed by PR or PR followed by CR) at least 4 weeks apart and not qualifying for a complete response (CR), 2) stable disease (SD): At least 1 SD assessment (or better)

    ≥ 43 days (assuming an 8-week scan interval with a 14-day visit window) after start of study treatment and not qualifying for CR or PR, 4) progressive disease (PD): Documentation of PD after start of study treatment (and not qualifying for CR, PR, or SD), 5) non-evaluable (NE): All other cases.

    Measured: Through study termination, approximately 3.5 years

  6. Best Tumor Shrinkage From Baseline

    Phase 1: The best shrinkage value for the target lesion from baseline

    Measured: Through study termination, approximately 3.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2021
  2. Study start8 Sep 2021
  3. Primary completion1 Apr 2025
  4. Study completion1 Apr 2025

Why it stopped: Sponsor decision to terminate during Phase 1

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05159388
Sponsor's protocol ID
CL1-95012-001
Other IDs
2023-510046-25-00, 2023
Status last verified
Jun 2026
First submitted
15 Nov 2021
Last updated
16 Jun 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data. Access can be requested for all interventional clinical studies: * used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US). * where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope. In addition, access can be requested for all interventional clinical studies in patients: * sponsored by Servier * with a first patient enrolled as of 1 January 2004 onwards * for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.

Publications

  • Jungels C, Kotecki N, Calvo E, Garralda E, Price T, Zahn X, Abbas A, Mahnke L, Rauschning W, Morales-Kastresana A, Lucia Pattarini L, Bossenmaier B, Scholer-Dahirel A, Demuth T, Legrande J. Abstract CT255: Study of PRS-344/S095012 a PD-L1/4-1BB bispecific antibody-Anticalin®-fusion in patients with solid tumors. Canc Res. 2022 Jun 15;82(12_Supplement):CT255. doi: https://doi.org/10.1158/1538-7445.AM2022-CT255

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing PRS-344/S095012 in people with Solid Tumor, run by Servier Bio-Innovation LLC at 11 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Australia, Belgium, Spain, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety Measurements: Number of Participants With at Least One DLT in the First 28-days of Treatment (time frame: 28 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05159388, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.

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Clinical Trial NCT05159388 | AzTrials