A Study of PRS-344/S095012 (PD-L1x4-1BB Bispecific Antibody-Anticalin Fusion) in Patients With Solid Tumors
- Registration Number
- NCT05159388
- Lead Sponsor
- Servier Bio-Innovation LLC
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
- 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 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.
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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.
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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.
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Patients who have received 4-1BB agonists in the past.
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Patients who had a major surgery within 4 weeks prior to first administration of IMP.
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History of progressive multifocal leukoencephalopathy.
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Active tuberculosis requiring treatment within 3 years prior to the start of treatment or a suspicion of latent tuberculosis by the investigator.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description PRS-344/S095012 PRS-344/S095012 PRS-344/S095012
- Primary Outcome Measures
Name Time Method Safety measurements 28 days Phase 1: Incidence of dose-limiting toxicities (DLTs) over the first 28-days of study treatment
Safety Measurements time on trial, average of 6 months Phase 1: Discontinuation of study treatment due to an AE
Objective Response (OR) 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 Outcome Measures
Name Time Method Mean PRS-344/S095012 concentrations at the end of the infusion Through study completion up to 24 months Phase 1
Mean PRS-344/S095012 trough concentrations (Ctrough) Through study completion up to 24 months Phase 1
Detection of anti-drug antibodies (ADA) against PRS-344/S095012 Through study completion up to 24 months Phase 1 and 2
Objective Response (OR) Through study completion up to 24 months Phase 1 and 2: Defined as Complete Response (CR) plus Partial Response (PR), per investigator assessment
Duration of Response (DoR) Through study completion up to 24 months Phase 1 and 2: Defined as the time from first demonstration of response to progression or death, whichever occurs first
Progression-free Survival (PFS) Through study completion up to 24 months Phase 1 and 2: Defined as the time from the first dose of treatment to first documented disease progression or death due to any cause, whichever occurs first
Overall Survival (OS) Through study completion up to 24 months Phase 1 and 2: Defined as the time from first dose of study drug to death due to any cause
Disease Control (DC) Through study completion up to 24 months Phase 2: The proportion of patients who achieved SD, PR, or CR (based on patient's best response)
Time to Response (TTR) Through study completion up to 24 months Phase 2: The time from the first dose of PRS-344/S095012 to the first documentation of CR or PR
Serum concentrations of PRS-344/S095012 Through study completion up to 24 months Phase 2
Safety measurements time on trial, average of 6 months Phase 2: Incidence of serious adverse events (AEs)
Trial Locations
- Locations (11)
Hospital Universitario Gregorio
🇪🇸Madrid, Spain
Chris O'Brian Lifehouse
🇦🇺Camperdown, Australia
START
🇪🇸Madrid, Spain
Carolina Bio Oncology
🇺🇸Huntersville, North Carolina, United States
NEXT Oncology
🇺🇸San Antonio, Texas, United States
The Queen Elizabeth Hospital
🇦🇺Woodville South, Australia
Hospital Vall d'Hebron
🇪🇸Barcelona, Spain
Institute Jules Bordet
🇧🇪Brussels, Belgium
Universitair Ziekenhuis
🇧🇪Edegem, Belgium
U.Z. Gent Medical Oncology
🇧🇪Gent, Belgium
Cabrini Oncology Research
🇦🇺Malvern, Victoria, Australia