OncoMatch/Clinical Trials/NCT05867251

Study of AVZO-021 in Patients With Advanced Solid Tumors

Is NCT05867251 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments for advanced solid tumor.

Phase 1/2RecruitingAvenzo Therapeutics, Inc.NCT05867251Data as of May 2026

Treatment: AVZO-021 · Palbociclib · Fulvestrant · Letrozole · Ribociclib · Abemaciclib · Carboplatin · Sacituzumab Govitecan-hziy — This study, the first clinical trial of AVZO-021, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and anti-tumor effects of AVZO-021 in patients with advanced solid tumors. AVZO-021 is an oral medication that inhibits cyclin-dependent kinase 2 (CDK 2).

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Extracted eligibility criteria

Cancer type

Tumor Agnostic

Breast Carcinoma

Ovarian Cancer

Endometrial Cancer

Triple-Negative Breast Cancer

Biomarker criteria

Required: CCNE1 amplification

CCNE1-amplified tumors ... CCNE1 amplification

Disease stage

Metastatic disease required

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Max 2 prior lines

Must have received: CDK4/6 inhibitor

previously treated with inhibitor of CDK4/6

Must have received: endocrine therapy

previously treated with ... endocrine therapy

Cannot have received: CDK2 inhibitor

Received any CDK2 inhibitor

Cannot have received: PKMYT1 inhibitor

Received any ... PKMYT1 inhibitor

Cannot have received: WEE1 inhibitor

Received any ... WEE1 inhibitor

Cannot have received: topoisomerase inhibitor

Exception: Cohort B5 only

For cohort B5, prior therapy with topoisomerase inhibitors is not permitted

Lab requirements

Blood counts

Adequate bone marrow function

Kidney function

Adequate organ function

Liver function

Adequate organ function

Adequate bone marrow and organ function.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

Yale Cancer Center · New Haven, Connecticut
Florida Cancer Specialists · Sarasota, Florida
Moffitt Cancer Center · Tampa, Florida
Perlmutter Cancer Center at NYU Langone Hospital - Long Island · Mineola, New York
NYU Langone Medical Center (Tisch Hospital) · New York, New York

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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