Clinical trial NCT06307795: A Study to Investigate ANS014004 in Participants With Locally Advanced or Metastatic Solid Tumors
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Locally Advanced or Metastatic Solid Tumors
Lead sponsor: Avistone Biotechnology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-03-13
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


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 (including MET mutation, MET amplification, MET overexpression, MET fusion)

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

Primary outcomes:
measure: Incidence of Adverse Events (AEs)
timeFrame: From the time of first dose to 28 days post last dose of ANS014004
measure: Incidence of Serious Adverse Events (SAEs)
timeFrame: From time of first dose to 28 days post last dose of ANS014004
measure: Incidence of dose-limiting toxicities (DLT) as defined in the protocol
timeFrame: From time of first dose of ANS014004 to end of DLT period (approximately 30 days)
measure: Incidence of baseline laboratory finding, ECG and vital signs changes
timeFrame: From time of first dose to 28 days post last dose of ANS014004
measure: Proportion of patients with radiological response (ORR)
timeFrame: From date of first dose of ANS014004 until progression, or the last evaluable assessment in the absence of progression （approximately 2 years)）
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: From date of first dose of ANS014004 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years)
measure: Duration of Response (DoR)
timeFrame: From date of first dose of ANS014004 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years)
measure: Disease Control Rate (DCR)
timeFrame: From date of first dose of ANS014004 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years)
measure: Progression free Survival (PFS)
timeFrame: rom date of first dose of ANS014004 up until date of progression or death due to any cause (approximately 2 years)
measure: Overall Survival (OS)
timeFrame: From date of first dose of ANS014004 up until the date of death due to any cause (approximately 2 years)
measure: Pharmacokinetics of ANS014004: Plasma PK concentrations
timeFrame: From date of first dose up until 28 days post last dose
measure: Pharmacokinetics of ANS014004: Area under the concentration time curve (AUC)
timeFrame: From date of first dose up until 28 days post last dose
measure: Pharmacokinetics of ANS014004: Maximum plasma concentration of the study drug (C-max)
timeFrame: From date of first dose up until 28 days post last dose
measure: Pharmacokinetics of ANS014004: Time to maximum plasma concentration of the study drug (T-max)
timeFrame: From date of first dose up until 28 days post last dose
measure: Pharmacokinetics of ANS014004: Clearance
timeFrame: From date of first dose up until 28 days post last dose
measure: Pharmacokinetics of ANS014004: Half-life
timeFrame: From date of first dose up until 28 days post last dose
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Research Site
state: California
city: Denver
country: United States
facility: Sarah Cannon Research Institute
state: Colorado
city: Orlando
country: United States
facility: Advent Health
state: Florida
city: Detroit
country: United States
facility: Research Site
state: Michigan
city: New York
country: United States
facility: Resarch Site
state: New York
city: Houston
country: United States
facility: The University of Texas - MD Anderson Cancer Center
state: Texas
city: Fairfax
country: United States
facility: NEXT Oncology, Virginia
state: Virginia
city: Seattle
country: United States
facility: Research Site
state: Washington
Study officials:
affiliation: Beijing Avistone Biotechnology Co., Ltd.
name: Medical Director Clinical Science
role: STUDY_DIRECTOR
References: