AVENTINE-1: Study of AVZO-1418 as a Single Agent and in Combination Therapy in Patients With Locally Advanced or Metastatic Solid Tumors (AVZO-1418-1001)

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
Avenzo Therapeutics, Inc.
Study ID
NCT07038343
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Biliary Tract Cancer (BTC)
  • Epithelial Tumor
  • Locally Advanced
  • Lung Cancers
  • Metastatic Solid Tumors
  • Nasopharyngeal Cancers
  • Solid Tumor Cancer
  • Urothelial Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • AVZO-1418 — DRUG
    Specific dose in protocol specified schedule
  • Combination Agent 1 — DRUG
    Per label based on combination agent used
  • Combination Agent 2 — DRUG
    Per label based on combination agent used

Study Details

This study, the first clinical trial of AVZO-1418, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and antitumor activity of AVZO-1418 when administered intravenously as a monotherapy and potentially in combination therapy to patients with locally advanced or metastatic epithelial solid tumors.

Key Dates

Start date
Jun 4, 2025
Status verified
Jan 2026
Primary completion
Jun 30, 2030
Completion
Dec 31, 2030

Study Design

Enrollment
480 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1, monotherapy
    Group A
  • Experimental: Phase 1, combination
    Group B
  • Experimental: Phase 2, monotherapy
    Part A
  • Experimental: Phase 2, combination
    Part B

Primary Outcome Measure

Occurrence of Dose Limiting Toxicities (DLTs) during the first cycle (Phase 1) [ Time Frame: Approximately 2 years ]

Central Contacts

Locations (18)

FacilityCityStateZIPSite coordinators
Avenzo Therapeutics Recruiting SiteGilbertArizona85234
Avenzo Therapeutics
Avenzo Therapeutics Recruiting SiteLos AngelesCalifornia90048
Avenzo Therapeutics
Avenzo Therapeutics Recruiting SiteDenverColorado80218
Avenzo Therapeutics
Avenzo Therapeutics Recruiting SiteNew HavenConnecticut06510
Avenzo Therapeutics
Avenzo Therapeutics Recruiting SiteWashington D.C.District of Columbia20007
Avenzo Therapeutics
Avenzo Therapeutics Recruiting SiteOrlandoFlorida32827
Avenzo Therapeutics
Avenzo Therapeutics Recruiting SiteSarasotaFlorida34232
Avenzo Therapeutics
Avenzo Therapeutics Recruiting SiteTampaFlorida33612
Avenzo Therapeutics
Avenzo Therapeutics Recruiting SiteAtlantaGeorgia30322
Avenzo Therapeutics
Avenzo Therapeutics Recruiting SiteBostonMassachusetts02215
Avenzo Therapeutics
Avenzo Therapeutics Recruiting SiteNew YorkNew York10029
Avenzo Therapeutics
Avenzo Therapeutics Recruiting SitePhiladelphiaPennsylvania19107
Avenzo Therapeutics
Avenzo Therapeutics Recruiting SiteDallasTexas75039
Avenzo Therapeutics
Avenzo Therapeutics Recruiting SiteHoustonTexas77054
Avenzo Therapeutics
Avenzo Therapeutics Recruiting SiteSan AntonioTexas78229
Avenzo Therapeutics
Avenzo Therapeutics Recruiting SiteWest Valley CityUtah84119
Avenzo Therapeutics
Avenzo Therapeutics Recruiting SiteFairfaxVirginia22031
Avenzo Therapeutics
Avenzo Therapeutics Recruiting SiteSeattleWashington98109
Avenzo Therapeutics

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