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.|
|ClinicalTrials.gov Identifier: NCT05159388|
Recruitment Status : Recruiting
First Posted : December 16, 2021
Last Update Posted : June 30, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor||Drug: PRS-344/S095012||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||130 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
- 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)
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
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
|Contact: Kayti Avianoemail@example.com|
|Contact: Onyeka Ogbonnayafirstname.lastname@example.org|
|United States, North Carolina|
|Carolina Bio Oncology||Recruiting|
|Huntersville, North Carolina, United States, 28078|
|Principal Investigator: John Powderly|
|United States, Texas|
|San Antonio, Texas, United States, 78229|
|Contact: Amanda Betancourt|
|Principal Investigator: Anthony Tolcher|
|Cabrini Oncology Research||Recruiting|
|Malvern, Victoria, Australia|
|Principal Investigator: Gary Richardson|
|Chris O'Brian Lifehouse||Recruiting|
|Contact: Lisa Horvath|
|Principal Investigator: Sara Wahlroos|
|The Queen Elizabeth Hospital||Recruiting|
|Woodville South, Australia|
|Contact: Kiddki Tran|
|Principal Investigator: Tim Price|
|Institute Jules Bordet||Recruiting|
|Principal Investigator: Christiane Jungles, MD|
|Principal Investigator: Hans Prenen|
|U.Z. Gent Medical Oncology||Recruiting|
|Principal Investigator: Sylvie Rottey|
|Hospital Vall d'Hebron||Recruiting|
|Contact: Montserrat Moreno|
|Principal Investigator: Elena Garralda Cabanas, MD|
|Madrid, Spain, 28050|
|Contact: Isabel Serna|
|Principal Investigator: Emiliano Calvo, MD|
|Hospital Universitario Gregorio||Recruiting|
|Principal Investigator: Atiana Calvo Ferrandiz|
|Study Director:||Tim Demuth, MD, PhD||Pieris Pharmaceuticals|
|Responsible Party:||Pieris Pharmaceuticals, Inc.|
|Other Study ID Numbers:||
2019-003456-36 ( EudraCT Number )
|First Posted:||December 16, 2021 Key Record Dates|
|Last Update Posted:||June 30, 2022|
|Last Verified:||June 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Solid Tumor = Phase 1/2