A Study to Evaluate ANS014004 in Subjects With Locally Advanced or Metastatic Solid Tumors

Locally Advanced or Metastatic Solid Tumors Clinical Trial

Official title: A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ANS014004 Monotherapy in Subjects With Locally Advanced or Metastatic Solid Tumors

Status Recruiting

Clinical Trial Summary

Brief Summary: This is a Phase I, first-in-human, open-label, multi-center study designed to explore the safety, tolerability, PK, and anti-tumor antitumor activity of ANS014004 monotherapy in subjects with locally advanced or metastatic solid tumors.

• The study consists of two parts: a dose-escalation part (Part 1) and a dose-expansion part (Part 2). For each subject, the study will consist of a screening period (Day -28 to Day -1), a treatment period (until discontinuation of treatment) and a follow-up period (including safety follow-up and survival follow-up).

• During the Treatment Period, subjects will receive ANS014004 single-agent oral administration until the subject meets any treatment termination criteria.

1, The dose-escalation part (Part 1) will consist of a single-dose period and a multiple-dose period (28 days per cycle), participants during dose escalation will receive a single dose of ANS014004 on Day 1 of the single-dose period in order to obtain complete PK parameters for the single dose. There will be a 7-day washout period between the single dosing period and the multiple dosing period at the same dose level. If no dose-limiting toxicity (DLT) occurs during the 7-day washout period, participants will begin Cycle 1 (28 days per cycle) multiple dosing treatment on Day 8, receiving ANS014004 once daily (QD). participants in the backfill cohort will enter the multiple dosing period directly. The specific dose which participant receives will depend on the different cohort assignments. The dose-escalation part (Part 1) will use the initial accelerated titration design (ATD) and the traditional "3 + 3" design to determine the MTD of ANS014004 in subjects with locally advanced or metastatic solid tumors.

2. In the Dose Expansion (Part 2), participants, will receive oral administration of ANS014004 QD at each treatment cycle (28 days per cycle). An end-of-treatment (EOT) visit will be conducted within 7 days of the final dose or investigator decision to discontinue.

All subjects will undergo imaging evaluations of their tumors every 8 weeks until disease progression is confirmed by the investigator, the subject begins new antitumor therapy, dies, is lost to follow-up, or withdraws from the study, whichever occurs first.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Locally Advanced or Metastatic Solid Tumors
• Neoplasms

• NCT number: NCT06328439
• Study type: Interventional
• Source: Avistone Biotechnology Co., Ltd.
• Contact: Weizhe Xue, Ph.D Weizhe Xue
• Phone: +86-10-84148931
• Email: xueweizhe@pearlbio.cn
• Status: Recruiting
• Phase: Phase 1
• Start date: March 19, 2024
• Completion date: January 31, 2028