A Study to Investigate ANS03 in Participants With Locally Advanced or Metastatic Solid Tumors

Part of paid clinical trials in New York, New York.

Sponsor
Avistone Biotechnology Co., Ltd.
Study ID
NCT06716138
Phase
PHASE1
Status
Recruiting

Conditions

  • Locally Advanced or Metastatic Solid Tumors Harboring a ROS1 or NTRK Alteration

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ANS03 — DRUG
    ANS03 is a rationally next generation TKI targeting both ROS1 and NTRK developed by Shenzhen Avistone Biotechnology (the sponsor).

Study Details

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.

Key Dates

Start date
Mar 6, 2025
Status verified
Mar 2026
Primary completion
Dec 30, 2027
Completion
Mar 30, 2029

Study Design

Enrollment
96 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: ANS03 monotherapy

Primary Outcome Measure

Incidence of Adverse Events (AEs) [ Time Frame: From the time of first dose to 28 days post last dose of ANS03 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Cancer CenterNew YorkNew York10022-

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