This is a multicenter, open-label Phase 1 trial to investigate the safety, PK, and pharmacodynamics of the Polθ inhibitor RP-3467 alone or in combination with the poly-ADP ribose polymerase inhibitor (PARPi) olaparib in adults with molecularly selected advanced solid tumors.
This is a first-in-human Phase 1, multi-center, open-label, dose-escalation study to: * Evaluate the safety profile of RP-3467 when administered orally alone and in combination with olaparib and to define the MTD or MAD for RP-3467 monotherapy and the RP2D for the combination * Characterize the PK profile of RP-3467 alone and in combination with olaparib
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Eligible participants will be treated with escalating doses of RP-3467 monotherapy
Eligible participants will be treated with escalating doses of RP-3467 in combination with Olaparib
# 1025, The University of California
San Francisco, California, United States
# 1011, The Washington University
St Louis, Missouri, United States
# 1008, Columbia University
New York, New York, United States
# 1004, Memorial Sloan-Kettering Cancer Center
New York, New York, United States
The Number of Participants Who Experienced Dose-limiting Toxicities (DLT) During the Study Treatment
The assessment of DLTs was conducted to evaluate the safety and tolerability of RP-3467 administered as monotherapy and in combination with olaparib in participants with advanced solid tumors.
Time frame: Start of treatment to 30 days post last dose, up to 13 months
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# 1001, The University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States