For Healthcare Professionals

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

clipboard-pencil

About the study

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.
user-3

Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

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

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.
  4. Patients who have received 4-1BB agonists in the past.
  5. Patients who had a major surgery within 4 weeks prior to first administration of IMP.
pin location

Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 781-605-8632Email iconEmail Study Center

Study Details


Contition

Solid Tumor

Age

18+

Phase

PHASE1/PHASE2

Participants Needed

130

Est. Completion Date

Oct 31, 2027

Treatment Type

INTERVENTIONAL


Sponsor

Servier

ClinicalTrials.gov NCT Identifier

NCT05159388

Study Number

CL1-95012-001

Understanding Clinical Trials


Get answers to your questions about clinical trials.What is clinical research?What does taking part in clinical trials involve?What should I ask the trial doctor?
Vector

Interested?

Sign up to create a personal profile and 
receive news, resources, and alerts 
about clinical trials related to your conditions of interest.