Clinical trial NCT06716138: A Study to Investigate ANS03 in Participants With Locally Advanced or Metastatic Solid Tumors
Official title: A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ANS03 as a Single Agent in Participants With Locally Advanced or Metastatic Solid Tumors Harboring a ROS1 or NTRK Alteration
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Locally Advanced or Metastatic Solid Tumors Harboring a ROS1 or NTRK Alteration
Keywords: ROS1/NTRK
ANS03
Lead sponsor: Avistone Biotechnology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-12-04
Enrollment: 96
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 first-in-human Phase I, multi-center, open-label study of ANS03 in patients with advanced solid tumors. The study evaluates the safety, tolerability, preliminary efficay, pharmacokinetics, anti-tumor activity of ANS03 as monotherapy.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-2
* Life expectancy ≥ 12 weeks
* Measurable disease per RECIST v1.1
* Adequate organ and marrow function as defined in the protocol
* With documentation of ROS1 or NTRK alteration

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 ANS03
measure: Incidence of Serious Adverse Events (SAEs)
timeFrame: From time of first dose to 28 days post last dose of ANS03
measure: Incidence of dose-limiting toxicities (DLT) as defined in the protocol
timeFrame: From time of first dose of ANS03 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 ANS03
measure: Proportion of patients with radiological response (ORR)
timeFrame: From date of first dose of ANS03 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 ANS03 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 ANS03 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 ANS03 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years)
measure: Progression free Survival (PFS)
timeFrame: From date of first dose of ANS03 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 ANS03 up until the date of death due to any cause (approximately 2 years)
measure: Pharmacokinetics of ANS03: Plasma PK concentrations
timeFrame: From date of first dose up until 28 days post last dose
measure: Pharmacokinetics of ANS03: Area under the concentration time curve (AUC)
timeFrame: From date of first dose up until 28 days post last dose
measure: Pharmacokinetics of ANS03: 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 ANS03: Time to maximum plasma concentration of the study drug (T-max)
timeFrame: Frame: From date of first dose up until 28 days post last dose
measure: Pharmacokinetics of ANS03: Clearance
timeFrame: From date of first dose up until 28 days post last dose
measure: Pharmacokinetics of ANS03: Half-life
timeFrame: From date of first dose up until 28 days post last dose
Other outcomes:
Locations:
city: New York
country: United States
facility: Research Site
state: New York
city: Fuzhou
country: China
facility: Research Site
state: Fujian
city: Guangzhou
country: China
facility: Research Site
state: Guangdong
city: Shanghai
country: China
facility: Research Site
state: Shanghai
city: Shanghai
country: China
facility: Research Site
state: Shanghai
city: Chengdu
country: China
facility: Research Site
state: Sichuan
Study officials:
References: