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

• ClinicalTrials.gov Identifier: NCT05159388
• Recruitment Status: Recruiting
• First Posted: December 16, 2021
• Last Update Posted: December 19, 2023
• Sponsor: Servier Bio-Innovation LLC
• Collaborator: Institut de Recherches Internationales Servier
• Information provided by (Responsible Party): Servier ( Servier Bio-Innovation LLC )

Tracking Information

• First Submitted Date: November 15, 2021
• First Posted Date: December 16, 2021
• Last Update Posted Date: December 19, 2023
• Actual Study Start Date: September 8, 2021
• Estimated Primary Completion Date: October 31, 2027 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 2, 2021)

• Safety measurements [ Time Frame: 28 days ]
  Incidence of dose-limiting toxicities (DLTs) over the first 28-days of study treatment
• Safety Measurements [ Time Frame: time on trial, average of 6 months ]
  Incidence of adverse events (AEs), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0
• Anti-tumor activity [ Time Frame: Through study completion up to 24 months ]
  Overall Response Rate (ORR)

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study of PRS-344/S095012 (PD-L1x4-1BB Bispecific Antibody-Anticalin Fusion) in Patients With Solid Tumors
• 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
• Brief 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.
• Detailed 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.
• Study Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Solid Tumor

Intervention

Drug: PRS-344/S095012

PRS-344/S095012 Monotherapy

Study Arms

Experimental: PRS-344/S095012

PRS-344/S095012

Intervention: Drug: PRS-344/S095012

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: May 12, 2022): 130
• Original Estimated Enrollment (submitted: December 2, 2021): 45
• Estimated Study Completion Date: October 31, 2027
• Estimated Primary Completion Date: October 31, 2027 (Final data collection date for primary outcome measure)

Eligibility 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:

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Kayti Aviano; 781-605-8632; aviano@pieris.com

Contact: Onyeka Ogbonnaya; ogbonnaya@pieris.com

• Listed Location Countries: Australia, Belgium, Spain, United States

Administrative Information

• NCT Number: NCT05159388
• Other Study ID Numbers: CL1-95012-001; 2019-003456-36 ( EudraCT Number )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Servier ( Servier Bio-Innovation LLC )
• Original Responsible Party: Pieris Pharmaceuticals, Inc.
• Current Study Sponsor: Servier Bio-Innovation LLC
• Original Study Sponsor: Pieris Pharmaceuticals, Inc.
• Collaborators: Institut de Recherches Internationales Servier

Investigators

• Study Director: Tim Demuth, MD, PhD; Pieris Pharmaceuticals

• PRS Account: Servier
• Verification Date: December 2023