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

Study Overview
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Brief Summary
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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.

Detailed Description
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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
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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
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Solid Tumor

Intervention / Treatment
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* Drug: PRS-344/S095012


Participation Criteria
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Eligibility Criteria
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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: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRS-344/S095012<br>PRS-344/S095012 | Drug: PRS-344/S095012<br>* PRS-344/S095012 Monotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety measurements | Incidence of dose-limiting toxicities (DLTs) over the first 28-days of study treatment | 28 days | 
| Safety Measurements | 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 | Overall Response Rate (ORR) | Through study completion up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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