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.
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. The study was terminated during phase 1 and thus, recruitment into phase 2 was not started.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
46
PRS-344/S095012 Monotherapy or with pretreatment by obinutuzumab
Carolina Bio Oncology
Huntersville, North Carolina, United States
NEXT Oncology
San Antonio, Texas, United States
Cabrini Oncology Research
Malvern, Victoria, Australia
Chris O'Brian Lifehouse
Safety Measurements: Number of Participants With at Least One DLT in the First 28-days of Treatment
Phase 1: Dose-limiting toxicities (DLTs) over the first 28-days of study treatment
Time frame: 28 days
Safety Measurements: Number of Participants With at Least One AE
Phase 1: Adverse events (AEs), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0
Time frame: Through study termination, approximately 3.5 years
Safety Measurements: Number of Participants With at Least One AE Leading to Treatment Discontinuation
Phase 1: Discontinuation of study treatment due to an AE
Time frame: Through study termination, approximately 3.5 years
Mean PRS-344/S095012 Concentrations at the End of the Infusion
Phase 1
Time frame: Cycle 1 Day 1 and Cycle 2 Day 1 (each cycle was 28 days)
Mean PRS-344/S095012 Trough Concentrations (Ctrough)
Phase 1
Time frame: Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Cycle 3 Day 1, Cycle 3 Day 15, Cycle 4 Day 1, Cycle 4 Day 15, Cycle 5 Day 1, Cycle 5 Day 15, Cycle 6 Day 1 (each cycle was up to 28 days)
Number of Participants With at Least One Positive Anti-drug Antibody (ADA) Titer Result PRS-344/S095012
Phase 1
Time frame: Through study termination, approximately 3.5 years
Objective Response Rate (ORR)
Phase 1: Defined as Complete Response (CR) plus Partial Response (PR), per investigator assessment
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Camperdown, Australia
The Queen Elizabeth Hospital
Woodville South, Australia
Institute Jules Bordet
Brussels, Belgium
Universitair Ziekenhuis
Edegem, Belgium
U.Z. Gent Medical Oncology
Ghent, Belgium
Hospital Vall d'Hebron
Barcelona, Spain
START
Madrid, Spain
...and 1 more locations
Time frame: Through study termination, approximately 3.5 years
Best Overall Response (BOR)
Phase 1: The best response across visits as; 1) partial response (PR): At least 2 PR or better (PR followed by PR or PR followed by CR) at least 4 weeks apart and not qualifying for a complete response (CR), 2) stable disease (SD): At least 1 SD assessment (or better) ≥ 43 days (assuming an 8-week scan interval with a 14-day visit window) after start of study treatment and not qualifying for CR or PR, 4) progressive disease (PD): Documentation of PD after start of study treatment (and not qualifying for CR, PR, or SD), 5) non-evaluable (NE): All other cases.
Time frame: Through study termination, approximately 3.5 years
Best Tumor Shrinkage From Baseline
Phase 1: The best shrinkage value for the target lesion from baseline
Time frame: Through study termination, approximately 3.5 years