Dosage: 1. Dose-escalation participants receive ANS014004 single dose on Day 1, if DLT does not occur within the 7-day elution period, subjects will begin multiple doses on Day 8 and receive ANS014004 QD (once daily) for a 28-day cycle. 2, Backfill, Dose Extension Subjects, who go directly to multiple dosing, will receive ANS014004 QD (once daily) for 28 days as a cycle.

Dosing Schedule: 1. Dose-escalation subjects, single dosing + multiple dosing, 35-day cycle. 2, Backfill, dose-expansion subjects, direct access to multiple dosing, 28 days to a cycle.

ANS014004

Weizhe Xue, Ph.D Weizhe Xue

Shun Lu, Ph.D

Shun Lu, Ph.D Shun Lu

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.

Cohort1: 7.5mg Cohort2: 15mg Cohort3: 30mg Cohort4: 45mg Cohort5: 60mg

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

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

Number of patients with adverse events by system organ class and preferred term

Number of patients with serious adverse events by system organ class and preferred term

Number of patients with at least 1 dose-limiting toxicity (DLT), which is any toxicity defined as a DLT in the Clinical Study Protocol

measured by laboratory and vital sign variables over time including change from

Assessed by overall response rate (ORR) defined as the proportion of patients who have a confirmed complete or partial radiological response by the Investigator according to RECIST v1.1

The percentage or number of patients with a confirmed investigator assessed complete or partial response according to response criteria in solid tumours (RECIST v1.1)

The percentage of patients with confirmed CR or PR or having SD maintained (RECIST v1.1)

From date of first dose of ANS014004 up until progression, or the last evaluable assessment in the absence of progression

The time from first dose until RECIST 1.1 defined disease progression or death due to any cause

The time from the date of the first dose of study treatment until death due to any cause

Measurement of plasma concentrations of ANS014004, total antibody and total unconjugated warhead

Measurement of PK parameters: Area under the concentration time curve (AUC)

Measurement of PK parameters: Maximum observed plasma concentration of the study drug (C-max)

Measurement of PK parameters: Time to maximum observed plasma concentration of the study drug (T-max)

Measurement of PK parameters: the volume of plasma from which the study drug is completely removed per unit time (Clearance)

Spots Global Cancer Trial Database for ans014004

Every month we try and update this database with for ans014004 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ans014004

Every month we try and update this database with for ans014004 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ans014004 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.