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

December 18, 2023 updated by: Servier Bio-Innovation LLC

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

130

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
      • Camperdown, Australia
        • Recruiting
        • Chris O'Brian Lifehouse
        • Contact:
          • Lisa Horvath
        • Principal Investigator:
          • Sara Wahlroos
      • Woodville South, Australia
        • Recruiting
        • The Queen Elizabeth Hospital
        • Contact:
          • Kiddki Tran
        • Principal Investigator:
          • Tim Price
    • Victoria
      • Malvern, Victoria, Australia
        • Recruiting
        • Cabrini Oncology Research
        • Principal Investigator:
          • Gary Richardson
  • Belgium
      • Brussels, Belgium
        • Recruiting
        • Institute Jules Bordet
        • Principal Investigator:
          • Christiane Jungles, MD
      • Edegem, Belgium
        • Recruiting
        • Universitair Ziekenhuis
        • Principal Investigator:
          • Hans Prenen
      • Gent, Belgium
        • Recruiting
        • U.Z. Gent Medical Oncology
        • Principal Investigator:
          • Sylvie Rottey
  • Spain
      • Barcelona, Spain
        • Recruiting
        • Hospital Vall d'Hebron
        • Contact:
          • Montserrat Moreno
        • Principal Investigator:
          • Elena Garralda Cabanas, MD
      • Madrid, Spain, 28050
        • Recruiting
        • START
        • Principal Investigator:
          • Emiliano Calvo, MD
        • Contact:
          • Isabel Serna
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario Gregorio
        • Principal Investigator:
          • Atiana Calvo Ferrandiz
  • United States
    • North Carolina
      • Huntersville, North Carolina, United States, 28078
        • Terminated
        • Carolina Bio Oncology
    • Texas
      • San Antonio, Texas, United States, 78229
        • Terminated
        • NEXT Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥18 years on the day the consent is signed.
  2. 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.
  3. Patient should have a documented disease progression on prior therapy before entry into this study.
  4. Patients must have at least one measurable target lesion as per RECIST 1.1.
  5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  6. Patient with no available archived material must have one or more tumor lesions amenable to biopsy.
  7. Adequate organ function as assessed by laboratory tests within 72 hours prior to the start of treatment.
  8. A female patient must use a highly effective method of birth control during study treatment and until 120 days after last dose of study treatment.

Exclusion Criteria:

  1. 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.

  2. Patients who have received prior:

    1. Small molecule inhibitors, and/or other similar investigational agent: ≤ 2 weeks or 5 half-lives, whichever is shorter.
    2. Chemotherapy, other monoclonal antibodies, antibody-drug conjugates, or other similar experimental therapies: ≤3 weeks or 5 half-lives, whichever is shorter.
    3. Radioimmunoconjugates or other similar experimental therapies ≤6 weeks or 5 half-lives, whichever is shorter.
  3. Patients who have received 4-1BB agonists in the past.
  4. Patients who had a major surgery within 4 weeks prior to first administration of IMP.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PRS-344/S095012
Drug: PRS-344/S095012
PRS-344/S095012 Monotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety measurements
Time Frame: 28 days
Incidence of dose-limiting toxicities (DLTs) over the first 28-days of study treatment
28 days
Safety Measurements
Time Frame: time on trial, average of 6 months
Incidence of adverse events (AEs), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0
time on trial, average of 6 months
Anti-tumor activity
Time Frame: Through study completion up to 24 months
Overall Response Rate (ORR)
Through study completion up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Servier Bio-Innovation LLC

Collaborators

Institut de Recherches Internationales Servier

Investigators

  • Study Director: Tim Demuth, MD, PhD, Pieris Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 8, 2021

Primary Completion (Estimated)

October 31, 2027

Study Completion (Estimated)

October 31, 2027

Study Registration Dates

First Submitted

November 15, 2021

First Submitted That Met QC Criteria

December 2, 2021

First Posted (Actual)

December 16, 2021

Study Record Updates

Last Update Posted (Estimated)

December 19, 2023

Last Update Submitted That Met QC Criteria

December 18, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL1-95012-001
  • 2019-003456-36 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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