A Study of HC-7366 to Establish the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D)
Status:
Not yet recruiting
Trial end date:
2024-10-01
Target enrollment:
Participant gender:
Summary
This is a first in human, multicenter, open label, Phase 1a/b dose escalation and dose
expansion study to establish the maximum tolerated dose (MTD), recommended Phase 2 dose
(RP2D), and evaluate the safety and tolerability of QD oral dosing of HC 7366 in a dose
escalating fashion in subjects with advanced solid tumors. Up to 36 subjects will be enrolled
into the Phase 1a dose escalation part of the study. Every effort will be made to ensure
approximately 50% of all subjects enrolled in this study will be subjects with the tumors of
special interest such as squamous cell carcinoma of the head and neck (SCCHN), colorectal
cancer (CRC), non-small cell lung cancer (NSCLC), and transitional cell carcinoma of the
bladder (TCC). Subjects with other solid tumor types are also eligible provided study
selection criteria are met and they do not exceed 50% of all enrolled subjects. The study
will be conducted in the United States at approximately 3 to 5 sites. This Phase 1a/b study
will follow a traditional 3+3 design. The starting dose level will be 10 mg QD, escalating to
20, 40, 75, 125, and 150 mg QD as safety allows. All doses are to be administered in the
fasting state with water at least 1 hour before food or at least 2 hours after food. The
Phase 1b dose expansion part will involve cohort expansion at up to 2 dose levels selected
from the dose escalation data by the safety monitoring committee (SMC), to obtain additional
safety and preliminary efficacy information. Each cohort in Phase 1b will enroll 15 subjects.
The study will be expanded into a Phase 2 study via protocol amendment which will then assess
the dose and tumor type(s) selected in Phase 1a/b as the most appropriate for further
clinical development. Subjects will be dosed until unacceptable toxicity, disease progression
per immune-related Response Evaluation Criteria in Solid Tumors (iRECIST), discontinuation of
treatment for other protocol allowed reason (eg, subject refusal), any other administrative
reasons, or after 2 years of treatment, whichever occurs first. For scheduling purposes,
dosing will occur in 3 week cycles and computed tomography (CT) scans will be conducted once
every 6 weeks with the first postbaseline scan after 6 weeks of dosing (precycle 3).