This is a Phase1, open-label, sequential dose-escalation and dose-expansion study of KD033 (SAR445710) in adult participants with advanced or metastatic solid tumors. The main purpose of this study is to test KD033 (SAR445710) at different dose levels to see if it is safe and well tolerated when given once every 2 weeks and when given weekly. Additional purposes of the study are to find out whether the study drug has anti-cancer effects and how the study drug is processed by the body.
The foreseen treatment duration is until disease progression, unacceptable toxicity, criterion for withdrawal or for a maximum of 2 years.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Pharmaceutical form: Solution for infusion Route of administration: intravenous (IV)
UCLA Hematology/Oncology, 2020 Santa Monica Boulevard, Suite 600 - Site 042
Santa Monica, California, United States
Moffitt Cancer Center - Site 102
Tampa, Florida, United States
Roswell Park Cancer Institute - 665 Elm St - Site 062
Buffalo, New York, United States
Fox Chase Cancer Center - 333 Cottman Avenue - Site 141
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center - Hillman Cancer Center - 5150 Centre Avenue, Suite 301 - Site 132
Pittsburgh, Pennsylvania, United States
Occurrence of Dose Limiting Toxicities (DLTs)
To evaluate the number of participants who experienced DLTs during the dose escalation phase
Time frame: Up to 28 days
Treatment Emergent Adverse Events (TEAEs) and Treatment-related AEs by Severity
To evaluate the number of TEAEs and treatment-related AEs by severity for all dose groups/cohorts according to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0)
Time frame: Up to 30 days after last treatment
Best Overall Response (BOR)
To evaluate the best overall response from study treatment according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) and Immune Response Evaluation Criteria in Solid Tumors (iRECIST) criteria per Investigator assessment
Time frame: Through study completion, an expected average of 1 year
Duration Of Response (DOR)
To evaluate the duration of response from study treatment according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) and Immune Response Evaluation Criteria in Solid Tumors (iRECIST) criteria per Investigator assessment
Time frame: Through study completion, an expected average of 1 year
Exploration of KD033 (SAR445710) Pharmacokinetic (PK) Profile - AUC
Area under the concentration versus time curve (AUC)
Time frame: Through study completion, an expected average of 1 year
Exploration of KD033 (SAR445710) Pharmacokinetic (PK) Profile - Cmax
Maximum plasma concentration observed (Cmax)
Time frame: Through study completion, an expected average of 1 year
Exploration of Anti-KD033 (SAR445710) Antibodies
To evaluate serum titers and assessment of neutralization of anti-KD033 (SAR445710) antibodies using blood samples collected during the dose escalation and dose expansion phases
Time frame: Through study completion, an expected average of 1 year
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