A Study of HC-5404-FU to Establish the Maximum Tolerated Dose (MTD)
Status:
Recruiting
Trial end date:
2022-04-01
Target enrollment:
Participant gender:
Summary
Study HC-404-FCP-2011 is a first in human, Phase 1a, multi-center, open-label study to
establish the maximum tolerated dose (MTD) and evaluate the safety and tolerability of oral
dosing of HC-5404-FU in a dose-escalating fashion. Up to 24 qualified subjects at 3 to 5 US
sites, who have specific tumor types of renal cell carcinoma (RCC), gastric cancer (GC),
metastatic breast cancer (MBC), small cell lung cancer (SCLC), and other solid tumors (e.g.,
non-small cell lung cancer, colorectal cancer, carcinoma of unknown primary) with the
exception of rapidly progressing neoplasms (e.g., pancreatic cancer, glioblastoma,
hepatocellular carcinoma) will receive HC-5404-FU. Every effort will be made to ensure
approximately 50% of all subjects enrolled will be subjects with RCC and GC. The starting
dose level is 25 mg twice daily (BID), escalating to 50, 100, and 200 mg BID as safety
allows, following the Bayesian Optimal Interval (BOIN) design. If MTD is not reached even at
the maximum dose level (200 mg BID is well tolerated), a higher dose level may be evaluated
based on the safety monitoring committee (SMC) recommendations after a comprehensive review
of the PK, safety, and efficacy data generated from the study. This Phase 1a will be expanded
into a Phase 1b/2a study through a protocol amendment and will then assess the dose and tumor
type(s) selected in Phase 1a 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), subject withdrawal, any other
administrative reasons, or after 2 years of treatment, whichever occurs first. Efficacy will
be assessed via Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1); computed
tomography (CT) scans will be conducted every 6 weeks. Safety, including occurrence of
dose-limiting toxicities (DLTs), pharmacokinetics (PK), and biomarker parameters will also be
assessed.