Recruiting PHASE1/PHASE2 INTERVENTIONAL 4-arm NCT05867251

Study of AVZO-021 in Patients With Advanced Solid Tumors

A Phase 1/2, First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of AVZO-021 as a Single Agent and in Combination Therapy in Patients With Advanced Solid Tumors

Sponsor: Avenzo Therapeutics, Inc.

Conditions Advanced Solid Tumor CCNE1 Amplification Endometrial Cancer Epithelial Ovarian Cancer Fallopian Tube Cancer HR+, HER2-, Advanced Breast Cancer HR+/HER2- Breast Cancer Primary Peritoneal Cancer TNBC - Triple-Negative Breast Cancer

Interventions AVZO-021 Abemaciclib Carboplatin Fulvestrant Letrozole Palbociclib Ribociclib Sacituzumab Govitecan-hziy

Updated 14 times since 2023 Last updated: Nov 17, 2025 Started: Aug 30, 2023 Primary completion: Jan 31, 2028 Completion: Jan 31, 2030

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE1/PHASE2 clinical study on Advanced Solid Tumor and CCNE1 Amplification, this trial is actively recruiting participants. The trial is conducted by Avenzo Therapeutics, Inc. and has accumulated 14 data snapshots since 2023. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

Change History

14 versions recorded

Dec 2025 — Present [monthly]

Recruiting PHASE1/PHASE2
Oct 2025 — Dec 2025 [monthly]

Recruiting PHASE1/PHASE2
Jun 2025 — Oct 2025 [monthly]

Recruiting PHASE1/PHASE2
May 2025 — Jun 2025 [monthly]

Recruiting PHASE1/PHASE2
Mar 2025 — May 2025 [monthly]

Recruiting PHASE1/PHASE2

▶ Show 9 earlier versions

Jan 2025 — Mar 2025 [monthly]

Recruiting PHASE1/PHASE2
Sep 2024 — Jan 2025 [monthly]

Recruiting PHASE1/PHASE2
Jul 2024 — Sep 2024 [monthly]

Recruiting PHASE1/PHASE2

Phase: PHASE1_PHASE2 → PHASE1/PHASE2
Jun 2024 — Jul 2024 [monthly]

Recruiting PHASE1_PHASE2
Mar 2024 — Jun 2024 [monthly]

Recruiting PHASE1_PHASE2
Jan 2024 — Mar 2024 [monthly]

Recruiting PHASE1_PHASE2
Nov 2023 — Jan 2024 [monthly]

Recruiting PHASE1_PHASE2
Oct 2023 — Nov 2023 [monthly]

Recruiting PHASE1_PHASE2

Status: Not Yet Recruiting → Recruiting
Jun 2023 — Oct 2023 [monthly]

Not Yet Recruiting PHASE1_PHASE2

First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Avenzo Therapeutics, Inc.

Data source: Avenzo Therapeutics, Inc.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Cleveland, United States , Dallas, United States , Fairfax, United States , Macquarie University, Australia , Mineola, United States , New Haven, United States , New York, United States , Oklahoma City, United States , Philadelphia, United States , Portland, United States and 3 more locations