A First in Human Phase 1-2 Open-Label, Multicenter, Dose Escalation and Expansion Study of PRS-344/S095012 in Patients With Solid Tumors

Servier Bio-Innovation LLC11 sites in 4 countries45 target enrollmentSeptember 8, 2021

ConditionsSolid Tumor

InterventionsPRS-344/S095012

DrugsPRS-344/S095012

Overview

Phase: Phase 1
Intervention: PRS-344/S095012
Conditions: Solid Tumor
Sponsor: Servier Bio-Innovation LLC
Enrollment: 45
Locations: 11
Primary Endpoint: Safety measurements
Status: Completed
Last Updated: 9 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

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.

Registry

clinicaltrials.gov

Start Date

September 8, 2021

End Date

April 8, 2025

Last Updated

9 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Servier Bio-Innovation LLC

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.
•Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
•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 7 days prior to pretreatment with obinutuzumab.
•A female patient must use a highly effective method of birth control during study treatment and for 120 days after last dose of PRS-344/S095012, or 18 months after the last obinutuzumab infusion, whichever comes the latest.

Exclusion Criteria

•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.
•History of progressive multifocal leukoencephalopathy.
•Active tuberculosis requiring treatment within 3 years prior to the start of treatment or a suspicion of latent tuberculosis by the investigator.

Arms & Interventions

PRS-344/S095012

Intervention: PRS-344/S095012

Outcomes

Primary Outcomes

Safety measurements

Time Frame: 28 days

Phase 1: 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

Phase 1: Discontinuation of study treatment due to an AE

Objective Response (OR)

Time Frame: Through study completion up to 24 months

Phase 2: Defined as Complete Response (CR) plus Partial Response (PR). For arms 1 and 2, per central assessment according to RECIST v1.1 criteria. For Arm 3, per central assessment and composite response criteria (digital medical photography and/or imaging as per RECIST v1.1)

Secondary Outcomes

Mean PRS-344/S095012 concentrations at the end of the infusion(Through study completion up to 24 months)
Mean PRS-344/S095012 trough concentrations (Ctrough)(Through study completion up to 24 months)
Detection of anti-drug antibodies (ADA) against PRS-344/S095012(Through study completion up to 24 months)
Objective Response (OR)(Through study completion up to 24 months)
Duration of Response (DoR)(Through study completion up to 24 months)
Progression-free Survival (PFS)(Through study completion up to 24 months)
Overall Survival (OS)(Through study completion up to 24 months)
Disease Control (DC)(Through study completion up to 24 months)
Time to Response (TTR)(Through study completion up to 24 months)
Serum concentrations of PRS-344/S095012(Through study completion up to 24 months)
Safety measurements(time on trial, average of 6 months)