ANS-014004

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.

一、第1部分(剂量递增) 1、主要目的 评价 ANS014004 在局部晚期或转移性实体瘤受试者中的耐受性和安全性。 确定 ANS014004 在局部晚期或转移性实体瘤受试者中的最大耐受剂量 (MTD) 和/或 推荐的II 期剂量 (RP2D)。 2、次要目的 评估 ANS014004 及其经鉴定后的主要代谢物的药代动力学 (PK) 特征。 评价 ANS014004 在局部晚期或转移性实体瘤受试者中的临床疗效。 3、探索性研究 探索性评估肿瘤组织/ctDNA中与ANS014004 疗效相关的生物标志物。 二、第2部分(剂量扩展) 1、主要目的 评价 ANS014004 在局部晚期或转移性实体瘤受试者中的抗肿瘤活性。 2、次要目的 评价 ANS014004 在局部晚期或转移性实体瘤受试者中的临床疗效。 评价 ANS014004 的总体耐受性和安全性。 评估 ANS014004 的药代动力学 (PK) 特征。 3、探索性研究 探索性评估肿瘤组织/ctDNA中与ANS014004 疗效相关的生物标志物。