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

NCT05159388 | Terminated Phase 1 Results FDA Drug

• 2 other identifiers: CL1-95012-0012023-510046-25-00
• Study Type: interventional
• Target: 46
• Locations: 4 countries
• Sites: 11

Brief 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.

Conditions

Solid Tumor

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

Outcome Measures

Primary Outcomes (3)

• 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

  28 days

• 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

  Through study termination, approximately 3.5 years

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

  Phase 1: Discontinuation of study treatment due to an AE

  Through study termination, approximately 3.5 years

Secondary Outcomes (6)

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

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

• Mean PRS-344/S095012 Trough Concentrations (Ctrough)

  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)

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

  Through study termination, approximately 3.5 years

• Objective Response Rate (ORR)

  Through study termination, approximately 3.5 years

• Best Overall Response (BOR)

  Through study termination, approximately 3.5 years

Study Arms (1)

PRS-344/S095012

EXPERIMENTAL

PRS-344/S095012

Drug: PRS-344/S095012

Interventions

PRS-344/S095012 DRUG

PRS-344/S095012 Monotherapy or with pretreatment by obinutuzumab

PRS-344/S095012

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Servier Bio-Innovation LLC: lead
• Institut de Recherches Internationales Servier: collaborator

Study Sites (11)

Carolina Bio Oncology

Huntersville, North Carolina, 28078, United States

Location

NEXT Oncology

San Antonio, Texas, 78229, United States

Location

Cabrini Oncology Research

Malvern, Victoria, Australia

Location

Chris O'Brian Lifehouse

Camperdown, Australia

Location

The Queen Elizabeth Hospital

Woodville South, Australia

Location

Institute Jules Bordet

Brussels, Belgium

Location

Universitair Ziekenhuis

Edegem, Belgium

Location

U.Z. Gent Medical Oncology

Ghent, Belgium

Location

Hospital Vall d'Hebron

Barcelona, Spain

Location

START

Madrid, 28050, Spain

Location

Hospital Universitario Gregorio

Madrid, Spain

Location

Related Publications (1)

• 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

  BACKGROUND

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The Sponsor decided to prematurely discontinue recruitment to the CL1-95012-001 study because the overall benefit-risk balance of PRS-344/S095012 was unfavorable. The participants in Phase 1 were allowed to continue the FU until disease progression or any other reason to discontinue study treatment. The Phase 2 dose expansion of the study was not initiated.

Results Point of Contact

• Title: Institut de Recherches Internationales Servier (I.R.I.S.)
• Organization: Clinical Studies Department

scientificinformation@servier.com

+33 1 55 72 60 00

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2021
• First Posted: December 16, 2021
• Study Start: September 8, 2021
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: June 16, 2026
• Results First Posted: June 16, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: After Marketing Authorization in EEA or US if the study is used for the approval.
• Access Criteria: Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.

Locations

US (2); BE (3); ES (3); AU (3)