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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05159388
Other study ID # CL1-95012-001
Secondary ID 2019-003456-36
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date September 8, 2021
Est. completion date October 31, 2027

Study information

Verified date December 2023
Source Servier
Contact Kayti Aviano
Phone 781-605-8632
Email aviano@pieris.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 130
Est. completion date October 31, 2027
Est. primary completion date October 31, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
PRS-344/S095012
PRS-344/S095012 Monotherapy

Locations

Country Name City State
Australia Chris O'Brian Lifehouse Camperdown
Australia Cabrini Oncology Research Malvern Victoria
Australia The Queen Elizabeth Hospital Woodville South
Belgium Institute Jules Bordet Brussels
Belgium Universitair Ziekenhuis Edegem
Belgium U.Z. Gent Medical Oncology Gent
Spain Hospital Vall d'Hebron Barcelona
Spain Hospital Universitario Gregorio Madrid
Spain START Madrid
United States Carolina Bio Oncology Huntersville North Carolina
United States NEXT Oncology San Antonio Texas

Sponsors (2)

Lead Sponsor Collaborator
Servier Bio-Innovation LLC Institut de Recherches Internationales Servier

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Spain, 

Outcome

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