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NCT06998407 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of HR+, HER2-, Advanced Breast Cancer and HR+/HER2- Breast Cancer, sponsored by Avenzo Therapeutics.

Recruiting
Registry status
Phase 1
Development phase
380
Enrollment target
9
Study locations

NCT06998407 is a Phase 1 study of HR+, HER2-, Advanced Breast Cancer and HR+/HER2- Breast Cancer that is actively recruiting participants, run by Avenzo Therapeutics. The registered enrollment target is 380 participants. The trial reports 9 study locations across 8 states.

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The verdict

NCT06998407, a Phase 1 study of HR+, HER2-, Advanced Breast Cancer and HR+/HER2- Breast Cancer, is actively recruiting participants, sponsored by Avenzo Therapeutics.

RECRUITING
Registry status
Phase 1
Development phase
380 participants
Enrollment target
9
Study locations

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).

Conditions Studied

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

Interventions

  • DRUG Letrozole
  • DRUG Fulvestrant
  • DRUG AVZO-021
  • DRUG AVZO-023

Study Locations (9)

Texas

  • Avenzo Therapeutics Recruiting Site - Houston
  • Avenzo Therapeutics Recruiting Site - San Antonio

California

  • Avenzo Therapeutics Recruiting Site - Los Angeles

Connecticut

  • Avenzo Therapeutics Recruiting Site - New Haven

Massachusetts

  • Avenzo Therapeutics Recruiting Site - Boston

New York

  • Avenzo Therapeutics Recruiting Site - New York

Ohio

  • Avenzo Therapeutics Recruiting Site - Cleveland

Tennessee

  • Avenzo Therapeutics Recruiting Site - Nashville

Virginia

  • Avenzo Therapeutics Recruiting Site - Fairfax

Trial Details

FieldValue
Enrollment Target 380 participants
Start Date 2025-08-20
Est. Completion 2030-08
Phase Phase 1

Sponsor

Avenzo Therapeutics

4 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06998407

The ClinicalTrials.gov registry entry for NCT06998407 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 380 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Avenzo Therapeutics, which has 4 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with HR+, HER2-, Advanced Breast Cancer appearing as the primary indexed condition, and to 4 interventions - of which Letrozole is the first listed.

NCT06998407 reports 9 study locations spanning 8 distinct geographic areas - top geographies include Texas, California, Connecticut.

Frequently Asked Questions

What is clinical trial NCT06998407 about?

NCT06998407 is a clinical study titled "ORION-1: Study of AVZO-023 as a Single Agent and in Combination With AVZO-021, and/or Endocrine Therapy in Advanced Solid Tumors". 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 kina...

What is the current status of trial NCT06998407?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 380 participants. The study started on 2025-08-20. Estimated completion is 2030-08.

What conditions does trial NCT06998407 study?

This clinical trial studies the following conditions: HR+, HER2-, Advanced Breast Cancer, HR+/HER2- Breast Cancer.

What interventions are being tested in trial NCT06998407?

The interventions under investigation include: Letrozole (DRUG), Fulvestrant (DRUG), AVZO-021 (DRUG), AVZO-023 (DRUG).

Who is sponsoring clinical trial NCT06998407?

This trial is sponsored by Avenzo Therapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06998407 being conducted?

This trial has 9 study locations across California, Connecticut, Massachusetts, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.