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

• Sponsor: Pieris Pharmaceuticals, Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05159388
• Collaborator: Institut de Recherches Internationales Servier (I.R.I.S.) (Other)
• Enrollment: 130
• Locations: 11
• Arm: 1
• Anticipated Duration (Months): 38.2
• Patients Per Site: 11.8
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Solid Tumor	Drug: PRS-344/S095012	Phase 1/Phase 2

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 130 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Sep 8, 2021
• Anticipated Primary Completion Date: Nov 15, 2024
• Anticipated Study Completion Date: Nov 15, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PRS-344/S095012 PRS-344/S095012	Drug: PRS-344/S095012; PRS-344/S095012 Monotherapy

Outcome Measures

Primary Outcome Measures

1. Safety measurements [28 days]

   Incidence of dose-limiting toxicities (DLTs) over the first 28-days of study treatment

2. Safety Measurements [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

3. Anti-tumor activity [Through study completion up to 24 months]

   Overall Response Rate (ORR)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

3. Small molecule inhibitors, and/or other similar investigational agent: ≤ 2 weeks or 5 half-lives, whichever is shorter.

4. Chemotherapy, other monoclonal antibodies, antibody-drug conjugates, or other similar experimental therapies: ≤3 weeks or 5 half-lives, whichever is shorter.

5. Radioimmunoconjugates or other similar experimental therapies ≤6 weeks or 5 half-lives, whichever is shorter.

6. Patients who have received 4-1BB agonists in the past.

7. Patients who had a major surgery within 4 weeks prior to first administration of IMP.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Carolina Bio Oncology	Huntersville	North Carolina	United States	28078
2	NEXT Oncology	San Antonio	Texas	United States	78229
3	Cabrini Oncology Research	Malvern	Victoria	Australia
4	Chris O'Brian Lifehouse	Camperdown		Australia
5	The Queen Elizabeth Hospital	Woodville South		Australia
6	Institute Jules Bordet	Brussels		Belgium
7	Universitair Ziekenhuis	Edegem		Belgium
8	U.Z. Gent Medical Oncology	Gent		Belgium
9	Hospital Vall d'Hebron	Barcelona		Spain
10	START	Madrid		Spain	28050
11	Hospital Universitario Gregorio	Madrid		Spain

Sponsors and Collaborators

• Pieris Pharmaceuticals, Inc.
• Institut de Recherches Internationales Servier (I.R.I.S.)

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Pieris Pharmaceuticals, Inc.
• ClinicalTrials.gov Identifier: NCT05159388
• Other Study ID Numbers: CL1-95012-001; 2019-003456-36
• First Posted: Dec 16, 2021
• Last Update Posted: Jun 30, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Pieris Pharmaceuticals, Inc.: 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: Neoplasms

Study Results

No Results Posted as of Jun 30, 2022