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Clinical Trial 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).

Clinical Trial Description

Subjects are to spend Cycle 1/Day 1 (C1D1) in the clinic followed by an overnight stay for safety monitoring and PK sampling. Subjects will be hospitalized for administration of the first 2 doses: C1D1 and Cycle 1/Day 2 (C1D2) (as local coronavirus disease 19 restrictions allow). After the initial hospital stay at the start of study, subjects will be seen in outpatient clinic on Days 8, 15, and 21 of Cycle 1 and thereafter, on the first day of each cycle for physical and laboratory assessments, adverse event (AE) and dosing compliance monitoring, and PK C3-C6; the End of Treatment visit will also be in person in outpatient clinic. An overnight stay for Cycle 1/Day 21 (C1D21) to C2D1 is optional. Subjects who discontinue before the first postbaseline CT scan for reasons other than disease progression, a treatment-related AE, or dose limiting toxicity (DLT) prior to completion of the DLT evaluation period will be replaced to ensure an adequate safety assessment at each dose level. Each subject will be treated for a maximum of 2 years and followed for a maximum of 2 years. Six dose-escalation levels are planned starting with 10 mg QD, escalating to 20, 40, 75, 125, and 150 mg QD. Dose escalation will follow a traditional 3+3 design. A minimum of 3 subjects will be enrolled in each cohort sequentially, with expansion to 6 subjects in each cohort as needed to determine the DLT. For each cohort, the first subject is a sentinel subject. Sentinel subjects will be dosed and followed for 4 days to assess safety and tolerability. If deemed safe and well tolerated, the remainder of the cohort (N=2) will be enrolled. If none of the first 3 subjects in a cohort experiences a study treatment related DLT during the first 21 days (DLT evaluation period), the next cohort may be enrolled. Before applying the dose escalation rules, 3 subjects in a given dose level must have received a minimum of 75% of the planned dose and have been evaluated for toxicity, unless one or more subjects experiences a DLT within the first 21 days. If the first 3 DLT evaluable subjects within a cohort experience no DLTs during the DLT evaluation period, the next cohort may enroll. In the case a subject does not receive a minimum of 75% of the planned dose, for any reason other than a DLT (ie, lost to follow-up), the subject may be replaced. DLT's will be reviewed by the Safety Monitoring Committee (SMC) when the planned number of subjects complete their DLT observation period using the dose-escalation rules. If the MTD is not reached even at the maximum dose level (150 mg QD is well tolerated), a higher dose level may be evaluated based on the SMC recommendations after a comprehensive review of the safety, PK, and efficacy data generated from the study. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05121948
Study type Interventional
Source HiberCell, Inc.
Contact Viviana Cecinato, MPharm
Phone 708-295-1226
Email [email protected]
Status Not yet recruiting
Phase Phase 1
Start date January 2022
Completion date October 2024

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