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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT05159388
Recruitment Status : Recruiting
First Posted : December 16, 2021
Last Update Posted : December 16, 2021
Institut de Recherches Internationales Servier (I.R.I.S.)
Information provided by (Responsible Party):
Pieris Pharmaceuticals, Inc.

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 2a)). The expansion part of the trial will be initiated once the optimal biological dose (OBD) has been determined.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 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 : September 8, 2021
Estimated Primary Completion Date : November 15, 2024
Estimated Study Completion Date : November 15, 2024

Arm Intervention/treatment
Experimental: PRS-344/S095012
Drug: PRS-344/S095012
PRS-344/S095012 Monotherapy

Primary Outcome Measures :
  1. Safety measurements [ Time Frame: 28 days ]
    Incidence of dose-limiting toxicities (DLTs) over the first 28-days of study treatment

  2. 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

  3. Anti-tumor activity [ Time Frame: Through study completion up to 24 months ]
    Overall Response Rate (ORR)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

    Dose Expansion

  9. Patients who have had prior checkpoint inhibitor (CPI) treatment in the past 6 months must have documented confirmed radiographic progression from it prior to study entry.
  10. Patients must have received and progressed on only one prior regimen in the metastatic setting comprising an PD-(L)1 plus chemotherapy.

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.

    Dose Expansion:

  5. Patient who received therapy with an irinotecan containing regimen.
  6. Patient must not be on warfarin, strong cytochrome P450 (CYP) 3A4 inducers, strong CYP3A4 inhibitors, or strong UGT1A1 inhibitors.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT05159388

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Contact: Kayti Aviano 781-605-8632
Contact: Saundra Kirven 984-364-0284

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Institute Jules Bordet Recruiting
Brussels, Belgium
Principal Investigator: Christiane Jungles, MD         
Sponsors and Collaborators
Pieris Pharmaceuticals, Inc.
Institut de Recherches Internationales Servier (I.R.I.S.)
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Study Director: Tim Demuth, MD, PhD Pieris Pharmaceuticals
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Responsible Party: Pieris Pharmaceuticals, Inc. Identifier: NCT05159388    
Other Study ID Numbers: CL1-95012-001
2019-003456-36 ( EudraCT Number )
First Posted: December 16, 2021    Key Record Dates
Last Update Posted: December 16, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Dose escalation
Anticalin protein
Additional relevant MeSH terms:
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