Skip to content
Find Clinical Trials

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

Servier Protocol Code: CL1-95012-001 Sponsor: Servier Bio-Innovation LLC Clinicaltrials.gov Identifier: NCT05159388 EudraCT Number: 2019-003456-36

Find a recruiting site

How to participate to the study?
If you think you are eligible for this study (see
eligibility criteria
below), you can identify the location closest to you and contact them directly. If you don’t find a location close to you, please contact Institut de Recherches Internationales Servier (I.R.I.S.)
Name: Institut de Recherches Internationales Servier, Département des études cliniques
Phone number: +33 1 55 72 60 00
The study has 11 locations

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.
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
Conditions
Solid Tumor
Interventions / Treatments
  • PRS-344/S095012
Other study id numbers
  • CL1-95012-001

Eligibility Criteria

Eligible age for the study

18 years and older (Adult, Older Adult)

Sexes

Male/Female

Accepts Healthy Volunteers

No

  • 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 7 days prior to pretreatment with obinutuzumab.
  • 8. 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.

  • 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.
  • 5. History of progressive multifocal leukoencephalopathy.
  • 6. Active tuberculosis requiring treatment within 3 years prior to the start of treatment or a suspicion of latent tuberculosis by the investigator.

How is the study designed?

Allocation
N/A
Interventional study model
Single Group
Participant Group / Arm
Experimental: PRS-344/S095012
PRS-344/S095012
Intervention / Treatment
Drug: PRS-344/S095012
PRS-344/S095012 Monotherapy

Keywords

Provided by Servier
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
Additional Relevant MeSH Terms Glioma
Neoplasm Metastasis