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

Trial Summary

What is the purpose of this trial?

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).

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+