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Trial record 1 of 1 for:    CL1-95012-001
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A Study of PRS-344/S095012 (PD-L1x4-1BB Bispecific Antibody-Anticalin Fusion) in Patients With Solid Tumors

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

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : September 8, 2021
Estimated Primary Completion Date : October 31, 2027
Estimated Study Completion Date : October 31, 2027
Arms and Interventions
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Arm Intervention/treatment
Experimental: PRS-344/S095012
PRS-344/S095012
 Drug: PRS-344/S095012
PRS-344/S095012 Monotherapy


Outcome Measures
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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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT05159388


Contacts
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Contact: Kayti Aviano 781-605-8632 aviano@pieris.com
Contact: Onyeka Ogbonnaya ogbonnaya@pieris.com

Locations
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United States, North Carolina
Carolina Bio Oncology Terminated
Huntersville, North Carolina, United States, 28078
United States, Texas
NEXT Oncology Terminated
San Antonio, Texas, United States, 78229
Australia, Victoria
Cabrini Oncology Research Recruiting
Malvern, Victoria, Australia
Principal Investigator: Gary Richardson         
Australia
Chris O'Brian Lifehouse Recruiting
Camperdown, Australia
Contact: Lisa Horvath         
Principal Investigator: Sara Wahlroos         
The Queen Elizabeth Hospital Recruiting
Woodville South, Australia
Contact: Kiddki Tran         
Principal Investigator: Tim Price         
Belgium
Institute Jules Bordet Recruiting
Brussels, Belgium
Principal Investigator: Christiane Jungles, MD         
Universitair Ziekenhuis Recruiting
Edegem, Belgium
Principal Investigator: Hans Prenen         
U.Z. Gent Medical Oncology Recruiting
Gent, Belgium
Principal Investigator: Sylvie Rottey         
Spain
Hospital Vall d'Hebron Recruiting
Barcelona, Spain
Contact: Montserrat Moreno         
Principal Investigator: Elena Garralda Cabanas, MD         
START Recruiting
Madrid, Spain, 28050
Contact: Isabel Serna         
Principal Investigator: Emiliano Calvo, MD         
Hospital Universitario Gregorio Recruiting
Madrid, Spain
Principal Investigator: Atiana Calvo Ferrandiz         
Sponsors and Collaborators
Servier Bio-Innovation LLC
Institut de Recherches Internationales Servier
Investigators
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Study Director: Tim Demuth, MD, PhD Pieris Pharmaceuticals
More Information
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Responsible Party: Servier Bio-Innovation LLC
ClinicalTrials.gov 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 19, 2023
Last Verified: December 2023
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 Servier ( Servier Bio-Innovation LLC ):
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:
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Neoplasms