A Study to Investigate ANS014004 in Participants With Locally Advanced or Metastatic Solid Tumors

Part of paid clinical trials in San Diego, California.

Sponsor
Avistone Biotechnology Co., Ltd.
Study ID
NCT06307795
Phase
PHASE1
Status
Recruiting

Conditions

  • Locally Advanced or Metastatic Solid Tumors

Eligibility Criteria

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

Interventions

  • ANS014004 — DRUG
    Varying doses of ANS014004

Study Details

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.

Key Dates

Start date
Jun 24, 2024
Status verified
Apr 2026
Primary completion
Apr 30, 2027
Completion
Oct 31, 2027

Study Design

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

Arms

  • Experimental: ANS014004 Monotherapy
    Part 1 aims to determine the safety, tolerability, maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of ANS014004. Part 2 aims to determine the safety, tolerability and evaluate anti-tumor activity of ANS014004 as monotherapy in select solid tumors.

Primary Outcome Measure

Incidence of Adverse Events (AEs) [ Time Frame: From the time of first dose to 28 days post last dose of ANS014004 ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
University of California, San DiegoSan DiegoCalifornia92093-
Sarah Cannon Research InstituteDenverColorado80218-
Advent HealthOrlandoFlorida32804-
Henry Ford Health CancerDetroitMichigan48202-
NYU Langone HealthNew YorkNew York10003-
The University of Texas - MD Anderson Cancer CenterHoustonTexas77030-
NEXT Oncology, VirginiaFairfaxVirginia22031-
Swedish Cancer InstituteSeattleWashington98195-

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