Study of AVZO-021 in Patients With Advanced Solid Tumors

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

430

Participants

Timeline

Start Date

August 30, 2023

Primary Completion Date

January 31, 2028

Study Completion Date

January 31, 2030

Conditions
Advanced Solid TumorHR+/HER2- Breast CancerHR+, HER2-, Advanced Breast CancerCCNE1 AmplificationEpithelial Ovarian CancerPrimary Peritoneal CancerFallopian Tube CancerEndometrial CancerTNBC - Triple-Negative Breast Cancer
Interventions
DRUG

AVZO-021

AVZO-021 is a selective and potent oral inhibitor of CDK2 being developed for the treatment of patients with advanced solid tumors with CDK2 dependency (1A), CCNE1 amplified solid tumors (2A), HR+/HER2- BC (1B1-1B5, 2B1-2B5) and CCNE1 amplified EOC (1C, 2C)

DRUG

Palbociclib

Antineoplastic agent, cyclin-dependent kinase 4/6 inhibitor

DRUG

Fulvestrant

Antineoplastic agent, estrogen receptor antagonist

DRUG

Letrozole

Antineoplastic agent, aromatase inhibitor

DRUG

Ribociclib

Antineoplastic CDK4/6 inhibitor

DRUG

Abemaciclib

Antineoplastic CDK4/6 inhibitor

DRUG

Carboplatin

Alkylating agent

DRUG

Sacituzumab Govitecan-hziy

Trop-2 antibody and topoisomerase inhibitor

Trial Locations (11)

19107

RECRUITING

Sidney Kimmel Cancer Center (SKCC) at Jefferson Health, Philadelphia

22031

RECRUITING

NEXT Virginia, Fairfax

33612

RECRUITING

Moffitt Cancer Center, Tampa

34232

RECRUITING

Florida Cancer Specialists, Sarasota

44106

RECRUITING

University Hospitals Cleveland Medical Center, Cleveland

73117

RECRUITING

Oklahoma University, Oklahoma City

75246

RECRUITING

Texas Oncology - DFW, Dallas

97213

RECRUITING

Providence Cancer Institute, Portland

06520

RECRUITING

Yale Cancer Center, New Haven

Unknown

RECRUITING

Macquarie University Hospital, Macquarie University

RECRUITING

Cancer Care Wollongong, Wollongong

Sponsors
All Listed Sponsors
lead

Avenzo Therapeutics, Inc.

INDUSTRY

NCT05867251 - Study of AVZO-021 in Patients With Advanced Solid Tumors | Biotech Hunter | Biotech Hunter