AVZO-023 for Breast Cancer

Recruiting at 7 trial locations

Overseen By Medical Information

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Avenzo Therapeutics, Inc.

Must not be taking: CYP3A4 inhibitors/inducers

Disqualifiers: Brain metastasis, Invasive malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

380 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new oral medication, AVZO-023, to evaluate its safety and effectiveness in treating advanced solid tumors, with a focus on HR+/HER2- breast cancer. Researchers aim to understand how the body processes and responds to AVZO-023 and to determine the optimal dose. Participants will take AVZO-023 in various combinations with other medications to identify the most effective regimen. Individuals with HR+/HER2- breast cancer who have not previously used similar CDK inhibitors may be suitable candidates. As a Phase 1 trial, this research seeks to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial requires that you stop taking any strong or moderate CYP3A4 inhibitors or inducers at least 2 weeks before starting the study. Additionally, you must not have had any anticancer treatment within 2 weeks or 5 half-lives of the drug, whichever is shorter, before the first dose.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that AVZO-023 is being tested independently to assess its safety and tolerability. This trial marks the first time the drug is being tested in humans. Although no previous studies confirm its safety, this early trial aims to identify any side effects and determine the optimal dose for patients.

For the combination of AVZO-023 and AVZO-021, the trial examines how these drugs interact. Specific safety information for this combination is not yet available. However, both drugs are tested in a controlled setting to ensure they do not cause serious side effects.

As this trial is in the early stages, it primarily focuses on evaluating the safety of these treatments for participants. Researchers will closely monitor participants for any adverse effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about AVZO-023 for breast cancer because it offers a novel approach compared to current treatment options. Unlike standard treatments like chemotherapy or hormone therapy, AVZO-023 is an oral medication taken twice daily, which could simplify the treatment regimen for patients. Additionally, AVZO-023 is being tested both alone and in combination with other drugs, like fulvestrant and letrozole, potentially enhancing its effectiveness for patients with hormone receptor-positive, HER2-negative metastatic breast cancer. This versatility and the possibility of a new mechanism of action make AVZO-023 a promising candidate in the fight against breast cancer.

What evidence suggests that AVZO-023 might be an effective treatment for breast cancer?

Research has shown that AVZO-023 is a new treatment designed to stop cancer cells from growing by targeting a protein called CDK4, which aids in cancer cell multiplication. Early lab studies suggest it could slow tumor growth. This trial examines AVZO-023 both as a monotherapy and in combination with other cancer treatments like fulvestrant or letrozole, specifically for breast cancer. Although this is the first trial in humans, the underlying research offers promise for those with advanced tumors. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with advanced solid tumors, including breast cancer, particularly those with genetic changes like Cyclin D1 or CDK4 gene amplification. Participants should be adults who have not responded to standard treatments.

Inclusion Criteria

My kidney, liver, and bone marrow are functioning well.

I am 18 or older, can care for myself, and expected to live more than 3 months.

My advanced cancer has been confirmed by lab tests.

Exclusion Criteria

History of drug-induced pneumonitis/interstitial lung disease

I have not taken any CDK inhibitor medications.

I have active brain metastasis or leptomeningeal disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1 Treatment

Escalating doses of AVZO-023 as monotherapy and in combination with AVZO-021 and/or endocrine therapy in 28-day cycles

28 days per cycle

Multiple visits per cycle

Phase 2 Treatment

AVZO-023 in combination therapy at RP2D in 28-day cycles with letrozole, fulvestrant, or AVZO-021

28 days per cycle

Multiple visits per cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

Approximately 2 years

What Are the Treatments Tested in This Trial?

Interventions

• AVZO-023

Trial Overview The study tests AVZO-023's safety and effectiveness alone or combined with AVZO-021 and/or endocrine therapies (like Letrozole or Fulvestrant) in treating advanced solid tumors. It will also determine the maximum dose patients can tolerate.

How Is the Trial Designed?

Group I: Phase 2, combination (Cohorts 2A, 2B, 2C, and 2D) Experimental Treatment 4 Interventions

Oral doses of AVZO-023 in 28-day cycles at the RP2D determined in Part 1B/1C, in combination with: 2A) letrozole 2B) fulvestrant 2C) AVZO-021 plus fulvestrant 2D) AVZO-021 plus letrozole

Group II: Phase 1, monotherapy (Part 1A) and food effect Experimental Treatment 2 Interventions

Escalating doses of twice daily, oral AVZO-023 in 28-day cycles, with addition of fulvestrant for patients with HR+/HER2- mBC

Group III: Phase 1, combination (Parts 1C) Experimental Treatment 3 Interventions

Escalating doses of twice daily, oral AVZO-023 in combination with once daily, oral AVZO-021, with once daily, oral letrozole in 28-day cycles

Group IV: Phase 1, combination (Parts 1B) Experimental Treatment 3 Interventions

Escalating doses of twice daily, oral AVZO-023 in combination with once daily, oral AVZO-021 in 28-day cycles, with addition of fulvestrant for patients with HR+/HER2- mBC

Who Is Running the Clinical Trial?

Avenzo Therapeutics, Inc.

Lead Sponsor

Trials

1

Recruited

430+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06998407

Study of AVZO-023 as a Single Agent and in Combination ... Phase 2 will assess the antitumor activity and confirm the RP2D of AVZO-023 in combination therapy in patients with HR+/HER2- locally advanced or mBC.

2. avenzotx.com avenzotx.com/press-releases/avenzo-therapeutics-initiates-phase-1-2-clinical-study-of-avzo-023-a-potential-best-in-class-novel-cdk4-selective-inhibitor/

Avenzo Therapeutics Initiates Phase 1/2 Clinical Study of ... AVZO-023 is being studied in a Phase 1/2 study for the treatment of advanced solid tumors and in combinations in HR+/HER2- metastatic breast cancer.

3. businesswire.com businesswire.com/news/home/20251030143206/en/Avenzo-Therapeutics-to-Present-Initial-Results-from-the-Phase-1-Study-of-AVZO-021-a-Potential-Best-in-Class-CDK2-Inhibitor-at-the-2025-San-Antonio-Breast-Cancer-Symposium

Avenzo Therapeutics to Present Initial Results from the ... AVZO-023 is being studied in a Phase 1/2 study for the treatment of advanced solid tumors and in combinations in HR+/HER2- metastatic breast ...

4. ctv.veeva.com ctv.veeva.com/study/a-phase-1-2-study-of-avzo-023-as-a-single-agent-and-in-combination-with-avzo-021-and-or-endocrine-t

Study of AVZO-023 as a Single Agent and in Combination ... This study, the first clinical trial of AVZO-023, aims to determine the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, ...

5. uclahealth.org uclahealth.org/clinical-trials/study-avzo-023-single-agent-and-combination-with-avzo-021

Study of AVZO-023 as a Single Agent and in Combination ... This study, the first clinical trial of AVZO-023, aims to determine the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, maximum tolerated ...

6. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2025-06541

Study of AVZO-023 as a Single Agent and in Combination ... This study, the first clinical trial of AVZO-023, aims to determine the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, maximum tolerated ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05867251

Study of AVZO-021 in Patients With Advanced Solid Tumors AVZO-021 is a compound being developed for the treatment of patients with advanced solid tumors, specifically, HR+/HER2- breast cancer and cyclin E1 (CCNE1) ...