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

Last updated: February 17, 2025
Sponsor: Servier Bio-Innovation LLC
Overall Status: Active - Not Recruiting

Phase

1/2

Condition

Neoplasms

Neuroblastoma

Treatment

PRS-344/S095012

Clinical Study ID

NCT05159388
CL1-95012-001
2019-003456-36
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥18 years on the day the consent is signed.

  2. Patients with histologically confirmed diagnosis of unresectable, locally advancedor metastatic solid tumor for which standard treatment options are not available, nolonger effective, or not tolerated.

  3. Patient should have a documented disease progression on prior therapy before entryinto 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 lesionsamenable to biopsy.

  7. Adequate organ function as assessed by laboratory tests within 7 days prior topretreatment with obinutuzumab.

  8. A female patient must use a highly effective method of birth control during studytreatment and for 120 days after last dose of PRS-344/S095012, or 18 months afterthe last obinutuzumab infusion, whichever comes the latest.

Exclusion

Exclusion Criteria:

  1. Patients with previously treated brain metastases may participate provided they areradiologically stable, clinically asymptomatic and are off immunosuppressivetherapies for at least 4 weeks. Low dose of steroid <10 mg/day prednisone orequivalent) is allowed.

  2. Patients who have received prior:

  3. Small molecule inhibitors, and/or other similar investigational agent: ≤ 2weeks or 5 half-lives, whichever is shorter.

  4. Chemotherapy, other monoclonal antibodies, antibody-drug conjugates, or othersimilar experimental therapies: ≤3 weeks or 5 half-lives, whichever is shorter.

  5. Radioimmunoconjugates or other similar experimental therapies ≤6 weeks or 5half-lives, whichever is shorter.

  6. Patients who have received 4-1BB agonists in the past.

  7. Patients who had a major surgery within 4 weeks prior to first administration ofIMP.

  8. History of progressive multifocal leukoencephalopathy.

  9. Active tuberculosis requiring treatment within 3 years prior to the start oftreatment or a suspicion of latent tuberculosis by the investigator.

Study Design

Total Participants: 45
Treatment Group(s): 1
Primary Treatment: PRS-344/S095012
Phase: 1/2
Study Start date:
September 08, 2021
Estimated Completion Date:
April 30, 2026

Study 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.

Connect with a study center

  • Cabrini Oncology Research

    Malvern, Victoria
    Australia

    Site Not Available

  • Chris O'Brian Lifehouse

    Camperdown,
    Australia

    Site Not Available

  • The Queen Elizabeth Hospital

    Woodville South,
    Australia

    Site Not Available

  • Institute Jules Bordet

    Brussels,
    Belgium

    Site Not Available

  • Universitair Ziekenhuis

    Edegem,
    Belgium

    Site Not Available

  • U.Z. Gent Medical Oncology

    Gent,
    Belgium

    Site Not Available

  • Hospital Vall d'Hebron

    Barcelona,
    Spain

    Site Not Available

  • Hospital Universitario Gregorio

    Madrid,
    Spain

    Site Not Available

  • START

    Madrid, 28050
    Spain

    Site Not Available

  • Carolina Bio Oncology

    Huntersville, North Carolina 28078
    United States

    Site Not Available

  • NEXT Oncology

    San Antonio, Texas 78229
    United States

    Site Not Available

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