The purpose of the study is to investigate the safety, tolerability, and preliminary anti-neoplastic activity of S095029 alone and in combination with Sym021 in patients with advanced solid tumor malignancies followed by an expansion phase of triple combinations. \*The study sponsor has made the decision not to move forward to the expansion part of the study due to strategic considerations, unrelated to any safety issues or concerns. The study will be stopped after completion of dose escalation parts 1a and 1b of the study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
51
S095029 will be administered via IV infusion every 2 weeks. Once the DLT evaluations period at the second dose level is completed and it is deemed as safe, the dose escalation part 1b will be initiated.
Sym021 will be administered at a fixed dose of 200mg. S095029 will be administered via IV infusion every 2 weeks. Once the RP2D dose of S95029 in combination with Sym21 is defined, dose expansion will begin.
START Midwest
Grand Rapids, Michigan, United States
Mary Crowley Cancer Research
Dallas, Texas, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
The START Center for Cancer Care
San Antonio, Texas, United States
Princess Margaret Cancer Centre
Toronto, Canada
Adverse Events (AEs) (Dose escalation part)
Incidence, severity, and relationship of AEs
Time frame: Through study completion, up to 2 years
Incidence of dose limiting toxicities (DLTs) (Dose escalation part)
DLTs observed during a 28-day period
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Objective Response Rate
Time frame: Through study completion, up to 2 years
Clinical Benefit Rate (CBR)
Assessment based on complete response, partial response and stable disease ≥ 6 months
Time frame: Through study completion, up to 2 years
Duration of response (DOR)
Time frame: Through study completion, up to 2 years
Progression Free Survival (PFS)
Time frame: Through study completion, up to 2 years
Overall Survival (OS)
Time frame: Through study completion, up to 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.