Recruiting NCT06307795
A Study to Investigate ANS014004 in Participants With Locally Advanced or Metastatic Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ANS014004.
- Who it may be relevant to
- Registry conditions: Locally Advanced or Metastatic Solid Tumors. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Canada, China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ANS014004 as a Single Agent in Participants With Locally Advanced or Metastatic Solid Tumors
Overview
This is a Phase 1, first-in-human, open-label, multi-center study with the aim of exploring the safety, tolerability, PK, and preliminary anti-tumor activity of ANS014004 as a single agent in participants with locally advanced or metastatic solid tumors.
Interventions
- Drug ANS014004
Varying doses of ANS014004
Primary outcome measures
- Incidence of Adverse Events (AEs) [Time frame: From the time of first dose to 28 days post last dose of ANS014004]
- Incidence of Serious Adverse Events (SAEs) [Time frame: From time of first dose to 28 days post last dose of ANS014004]
- Incidence of dose-limiting toxicities (DLT) as defined in the protocol [Time frame: From time of first dose of ANS014004 to end of DLT period (approximately 30 days)]
- Incidence of baseline laboratory finding, ECG and vital signs changes [Time frame: From time of first dose to 28 days post last dose of ANS014004]
- Proportion of patients with radiological response (ORR) [Time frame: From date of first dose of ANS014004 until progression, or the last evaluable assessment in the absence of progression （approximately 2 years)）]
Secondary outcome measures (11)
- Objective Response Rate (ORR) [Time frame: From date of first dose of ANS014004 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years)]
- Duration of Response (DoR) [Time frame: From date of first dose of ANS014004 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years)]
- Disease Control Rate (DCR) [Time frame: From date of first dose of ANS014004 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years)]
- Progression free Survival (PFS) [Time frame: rom date of first dose of ANS014004 up until date of progression or death due to any cause (approximately 2 years)]
- Overall Survival (OS) [Time frame: From date of first dose of ANS014004 up until the date of death due to any cause (approximately 2 years)]
- Pharmacokinetics of ANS014004: Plasma PK concentrations [Time frame: From date of first dose up until 28 days post last dose]
- Pharmacokinetics of ANS014004: Area under the concentration time curve (AUC) [Time frame: From date of first dose up until 28 days post last dose]
- Pharmacokinetics of ANS014004: Maximum plasma concentration of the study drug (C-max) [Time frame: From date of first dose up until 28 days post last dose]
- Pharmacokinetics of ANS014004: Time to maximum plasma concentration of the study drug (T-max) [Time frame: From date of first dose up until 28 days post last dose]
- Pharmacokinetics of ANS014004: Clearance [Time frame: From date of first dose up until 28 days post last dose]
- Pharmacokinetics of ANS014004: Half-life [Time frame: From date of first dose up until 28 days post last dose]
Eligibility criteria
Inclusion criteria
- Age ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1
- Life expectancy ≥ 12 weeks
- Measurable disease per RECIST v1.1
- Adequate organ and marrow function as defined in the protocol
- With a pathogenetic MET alteration or ROS1 alteration or NTRK alternation
Exclusion criteria
- Active infection including tuberculosis and HBV, HCV or HIV
- Known active or untreated CNS metastases
- Participants with carcinomatous meningitis or meningeal metastases, or spinal cord compression
- Participants with serious cardiovascular or cerebrovascular diseases
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 8 centers
- University of California, San Diego — San Diego
- Sarah Cannon Research Institute — Denver
- Advent Health — Orlando
- Henry Ford Health Cancer — Detroit
- NYU Langone Health — New York
- The University of Texas - MD Anderson Cancer Center — Houston
- NEXT Oncology, Virginia — Fairfax
- Swedish Cancer Institute — Seattle
China · 5 centers
- Beijing Chest Hospital — Beijing
- Harbin Medical University Cancer Hospital — Harbin
- Henan Cancer Hospital — Zhengzhou
- Shandong Cancer Hospital — Jinan
- Shanghai Chest Hospital — Shanghai
Canada · 2 centers
- BC Cancer Vancouver Centre — Vancouver
- Princess Margaret Cancer Centre — Toronto
Identifiers
NCT: NCT06307795 · ANS014004-I-US-01