A Phase I/II, First-in-human Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of AVZO-023 as a Single Agent, and in Combination With AVZO-021 and/or Endocrine Therapy in Patients With Advanced Solid Tumors

Study Identifier:
AVZO-023-1001
CT.gov Identifier:
NCT06998407
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Recruiting

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Study Summary

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).

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Breast Cancers
  • Solid Tumor
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I/II
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: Phase 1, monotherapy (Part 1A) and food effect
    • Read More
  • Drug: Drug: AVZO-023
  • Drug: Experimental: Phase 1, combination (Parts 1B)
  • Drug: Drug: Fulvestrant
  • Drug: Experimental: Phase 1, combination (Parts 1C)
  • Drug: Drug: Letrozole
  • Drug: Experimental: Phase 2, combination (Cohorts 2A, 2B, 2C, and 2D)
  • Drug: 2A) letrozole
  • Drug: 2B) fulvestrant
  • Drug: 2C) AVZO-021 plus fulvestrant
  • Drug: 2D) AVZO-021 plus letrozole
  • Drug: Drug: AVZO-021
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    Inclusion criteria
    • Inclusion criteria
    • * Male or female aged ≥ 18 years old at screening with Eastern Cooperative Oncology Group (ECOG) 0-1 and life expectancy \> 3 months
    • * Patients with histologically or cytologically proven advanced malignancies of preferred indications
    • * Measurable disease (as assessed by investigator using RECIST v1.1) is preferred in Phase 1 dose escalation, unless otherwise specified in the protocol, and in all patients in Phase 2. For patients with HR+/HER2- breast cancer enrolled in dose escalation, bone only disease is allowed
    • * Agree to provide molecular test report results to confirm eligibility and archival tumor samples and/or fresh biopsy, as applicable
    • * Adequate renal, liver, and bone marrow function
    Exclusion criteria
    • * Patients should not have received prior selective CDK (CDK2, CDK4, CDK2/4, CDK2/4/6) inhibitors
    • * Has known active brain metastasis (have either previously untreated intracranial CNS metastasis or previously treated intracranial central nervous system (CNS) metastasis with radiologically documented new or progressing CNS lesions) or leptomeningeal disease
    • * Other concurrent invasive malignancy or a prior invasive malignancy for which treatment was completed within 3 years before the first dose on study except for adequately treated basal cell or squamous cell skin cancer, carcinoma in situ, or colorectal adenomatous polyps
    • * Last anticancer treatment within 2 weeks (4 weeks for biologic, immunotherapy or ADC) or 5 half-lives of the drug, whichever is shorter, prior to first dose on study
    • * Major surgery within 4 weeks prior to first dose on study
    • * Have received radiotherapy with a limited field of radiation for palliation within 7 days of the first dose of study treatment, except for patients receiving whole brain radiotherapy, which must be completed at least 4 weeks prior to the first dose of study treatment. Patients must have recovered from all radiation-related toxicities, not require corticosteroids, and not have active radiation pneumonitis
    • * Strong or moderate CYP3A4 inhibitors or inducers within 2 weeks or 5 half-lives of the drug, whichever is shorter, prior to first dose on study
    • * History of serious cardiovascular conditions within 6 months prior to first dose on study
    • * Unresolved toxicities from prior therapy greater than Grade 1 (per CTCAE version 5.0) (with exceptions of alopecia, vitiligo, and ≤ Grade 2 peripheral neuropathy) prior to the first dose on study
    • * History of drug-induced pneumonitis/interstitial lung disease

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Dallas Fort Worth
    Fort Worth, TX, United States, 76104
    Investigator
    Henry Xiong
    Status
    Will Be Recruiting
    Condition(s) Treated at Site
    Breast Cancers
    Solid Tumor
    Location
    START San Antonio
    San Antonio, TX, United States, 78229
    Investigator
    Amita Patnaik
    Status
    Will Be Recruiting
    Condition(s) Treated at Site
    Breast Cancers
    Solid Tumor