A Study of PRS-344/S095012 (PD-L1x4-1BB Bispecific Antibody-Anticalin Fusion) in Patients With Solid Tumors
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
- 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 72 hours prior to the start of treatment.
- 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:
- 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.
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.
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
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