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

Advanced Solid Tumors Clinical Trial

Official title: 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 Enrolling by invitation

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Neoplasms

• NCT number: NCT05818917
• Study type: Interventional
• Source: Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd.
• Status: Enrolling by invitation
• Phase: Phase 1
• Start date: July 7, 2022
• Completion date: July 31, 2024