ORION-1: Study of AVZO-023 as a Single Agent and in Combination With AVZO-021, and/or Endocrine Therapy in Advanced Solid Tumors

Part of paid clinical trials in Los Angeles, California.

Sponsor
Avenzo Therapeutics, Inc.
Study ID
NCT06998407
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • HR+, HER2-, Advanced Breast Cancer
  • HR+/HER2- Breast Cancer

Eligibility Criteria

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

Interventions

  • AVZO-021 — DRUG
    AVZO-021 is an oral selective CDK2 inhibitor
  • Fulvestrant — DRUG
    Antineoplastic agent, estrogen receptor antagonist
  • Letrozole — DRUG
    Antineoplastic agent, aromatase inhibitor
  • AVZO-023 — DRUG
    AVZO-023 is an oral selective CDK4 inhibitor

Study Details

This study, the first clinical trial of AVZO-023, aims to determine the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, maximum tolerated dose, and anti-tumor effects of AVZO-023 in patients with advanced solid tumors. AVZO-023 is an oral medication that inhibits cyclin-dependent kinase 4 (CDK4).

Key Dates

Start date
Aug 20, 2025
Status verified
Feb 2026
Primary completion
Aug 31, 2028
Completion
Aug 31, 2030

Study Design

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

Arms

  • Experimental: Phase 1, monotherapy (Part 1A) and food effect
    Escalating doses of twice daily, oral AVZO-023 in 28-day cycles, with addition of fulvestrant
  • Experimental: Phase 1, combination (Parts 1B)
    Escalating doses of twice daily, oral AVZO-023 in combination with once daily, oral AVZO-021 in 28-day cycles, with addition of fulvestrant
  • Experimental: Phase 1, combination (Parts 1C)
    Escalating doses of twice daily, oral AVZO-023 in combination with once daily, oral AVZO-021, with once daily, oral letrozole in 28-day cycles
  • Experimental: Phase 2, combination (Cohorts 2A, 2B, 2C, and 2D)
    Oral doses of AVZO-023 in 28-day cycles at the RP2D determined in Part 1B/1C, in combination with: 2A) letrozole 2B) fulvestrant 2C) AVZO-021 plus fulvestrant 2D) AVZO-021 plus letrozole

Primary Outcome Measure

Occurrence of Dose Limiting Toxicities (DLTs) during the first cycle (Phase 1) [ Time Frame: Cycle 1 (28 Days) ]

Central Contacts

Locations (14)

FacilityCityStateZIPSite coordinators
Avenzo Therapeutics Recruiting SiteLos AngelesCalifornia90025
Avenzo Therapeutics
Avenzo Therapeutics Recruiting SiteLos AngelesCalifornia90095
Avenzo Therapeutics
Avenzo Therapeutics Recruiting SiteNew HavenConnecticut06519
Avenzo Therapeutics
Avenzo Therapeutics Recruiting SiteOrlandoFlorida32827
Avenzo Therapeutics
Avenzo Therapeutics Recruiting SiteSarasotaFlorida34232
Avenzo Therapeutics
Avenzo Therapeutics Recruiting SiteBostonMassachusetts02215
Avenzo Therapeutics
Avenzo Therapeutics Recruiting SiteNew YorkNew York10016
Avenzo Therapeutics
Avenzo Therapeutics Recruiting SiteClevelandOhio44106
Avenzo Therapeutics
Avenzo Therapeutics Recruiting SiteColumbusOhio43221
Avenzo Therapeutics
Avenzo Therapeutics Recruiting SiteNashvilleTennessee37203
Avenzo Therapeutics
Avenzo Therapeutics Recruiting SiteFort WorthTexas76104
Avenzo Therapeutics
Avenzo Therapeutics Recruiting SiteHoustonTexas77030
Avenzo Therapeutics
Avenzo Therapeutics Recruiting SiteSan AntonioTexas78229
Avenzo Therapeutics
Avenzo Therapeutics Recruiting SiteFairfaxVirginia22031
Avenzo Therapeutics

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