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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- Breast Cancer and HR+, HER2-, Advanced Breast Cancer, sponsored by Avenzo Therapeutics.

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

NCT06998407: Recruiting Phase 1 study of HR+ HER2- Breast Cancer and HR+, HER2-, Advanced Breast Cancer, sponsored by Avenzo Therapeutics.

NCT06998407 is a Phase 1 study of HR+ HER2- Breast Cancer and HR+, HER2-, Advanced Breast Cancer that is actively recruiting participants, run by Avenzo Therapeutics. The registered enrollment target is 380 participants, above the 245-participant average among 3 other HR+ HER2- Breast Cancer trials with a reported enrollment target (55% higher). The trial reports 9 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06998407, a Phase 1 study of HR+ HER2- Breast Cancer and HR+, HER2-, Advanced 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).

Primary Outcome

Number of participants with DLTs assessed for severity using CTCAE v5.0 criteria will be summarized by dose level.

Conditions Studied

HR+ HER2- Breast Cancer HR+, HER2-, Advanced 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
Avenzo Therapeutics

4 total trials

What NCT06998407 shows while recruiting

NCT06998407 is an interventional study that assigns participants to a tested intervention. The registered 380 participants enrollment target is mid-sized for trials with a published cap, above the 245-participant average among 3 other HR+ HER2- Breast Cancer trials with a reported enrollment target (55% higher).

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

NCT06998407 lists 9 locations in 8 states (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- Breast Cancer, HR+, HER2-, Advanced 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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More recruiting context for NCT06998407

Source: ClinicalTrials.gov NCT06998407, the US trial registry maintained by the National Library of Medicine. NCT06998407 (mid enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.