Clinical Trials in the USA / NCT07538804
Recruiting
Phase 1/2
A Study to Investigate ANS02 in Participants With EGFR Mutation-Positive Non-Small Cell Lung Cancer
NCT07538804 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Non-Small Cell Lung Cancer
Investigational drug(s) / intervention(s)
ANS02
ANS02: 4 dose levels would be explored during the study.
Study summary
This is a first-in-human (FIH) Phase I/II, multi-center, open-label, study of ANS02, in patients with advanced NSCLC. The study evaluates the safety, tolerability, preliminary efficay, pharmacokinetics, anti-tumor activity of ANS02 as monotherapy.
Eligibility
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 documentation of EGFR 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 outcome measure(s)
- Incidence of Adverse Events (AEs) — From the time of first dose to 28 days post last dose of ANS02
Number of patients with adverse events by system organ class and preferred term - Incidence of Serious Adverse Events (SAEs) — From time of first dose to 28 days post last dose of ANS02
Number of patients with serious adverse events by system organ class and preferred term - Incidence of dose-limiting toxicities (DLT) as defined in the protocol — From time of first dose of ANS02 to end of DLT period (approximately 28 days)
Number of patients with at least 1 dose-limiting toxicity (DLT), which is any toxicity defined as a DLT in the Clinical Study Protocol - Incidence of baseline laboratory finding, ECG and vital signs changes — From time of first dose to 28 days post last dose of ANS02
Measured by laboratory and vital sign variables over time including change from baseline
Trial sites (5)
| Facility | City | Region | Status |
|---|---|---|---|
| Research Site | Fairfax | Virginia | Recruiting |
| Research Site | Guangzhou | Guangdong | Not Yet Recruiting |
| Research Site | Harbin | Heilongjiang | Recruiting |
| Research Site | Zhengzhou | Henan | Not Yet Recruiting |
| Study Site | Chengdu | Sichuan | Not Yet Recruiting |
More Avistone Biotechnology Co., Ltd. trials in the USA
Other trials for the same condition
A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-6036 Alone or in Combination in Participants With Advanced or Metastatic Solid Tumors With a KRAS G12C Mutation
Active, not recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07538804 on ClinicalTrials.gov ↗ ← All trials in the USA