NCT05818917

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Evidence of Antitumor Activity of FHND5071 as a Single Agent in Adult Patients With Advanced Solid Tumors

A Phase 1, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Evidence of Antitumor Activity of FHND5071 as a Single Agent in Adult Patients With Advanced Solid Tumors

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1, first-in-human, open-label dose-escalation study to determine the MTD and/or recommended Phase 2 dose (RP2D) and assess the DLT of FHND5071. The safety, tolerability, and PK of FHND5071 will be assessed in adult patients with advanced solid tumors. The total number of evaluable subjects in the study will depend upon the number of dose-escalations necessary. It is estimated that approximately 24 evaluable subjects will be enrolled in the dose-escalation part of this study. This multicenter study will be conducted in the United States. Dose-escalation of FHND5071 will follow two sequential parts: 1. a modified accelerated titration design in single subject cohorts with a starting dose level of 40 mg, where the FHND5071 dose would be doubled in each dose cohort until the subject in a current cohort experience a Grade ≥2 adverse event that is at least possibly related to FHND5071 in the opinion of the Investigator and the Medical Monitor; 2. a modified 3+3 escalation design in cohort of 3-6 subjects, where the FHND5071 dose would be escalated in ≤100% increments determined by the Safety Review Committee (SRC) until 2 of 3 or 2 of 6 subjects experience a DLT. In both parts of dose escalation, FHND5071 will be administered orally once daily (QD) in 28-day treatment cycles. Escalation cohorts may explore alternative doses or different schedules, if deemed appropriate by the Safety Review Committee.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	FHND5071	The proposed starting dose is 40 mg FHND5071 once daily (QD) orally (PO). For the purposes of this study treatment cycles will be 28 days or 4 weeks. FHND5071 will be administered orally in the morning following a fast of approximately 10 hours before dosing on PK collection days. Subjects will continue to fast for approximately 4 hours after the administration of FHND5071. On non-PK days the subjects will fast approximately 2 hours before FHND5071 and continue to fast for approximately 2 hours afterwards. Other dosing regimens may be considered based on the analysis of emerging PK, progressive disease, and/or safety data.

Timeline

• Start date: 2022-07-07
• Primary completion: 2023-12-31
• Completion: 2024-07-31
• First posted: 2023-04-19
• Last updated: 2023-04-19

Locations

2 sites across 1 country: China