Study of AVZO-021 in Patients With Advanced Solid Tumors

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• AVZO-021 — DRUG
  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)
• Palbociclib — DRUG
  Antineoplastic agent, cyclin-dependent kinase 4/6 inhibitor
• Fulvestrant — DRUG
  Antineoplastic agent, estrogen receptor antagonist
• Letrozole — DRUG
  Antineoplastic agent, aromatase inhibitor
• Ribociclib — DRUG
  Antineoplastic CDK4/6 inhibitor
• Abemaciclib — DRUG
  Antineoplastic CDK4/6 inhibitor
• Carboplatin — DRUG
  Alkylating agent
• Sacituzumab Govitecan-hziy — DRUG
  Trop-2 antibody and topoisomerase inhibitor

Study Details

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).

Key Dates

Start date

Aug 30, 2023

Status verified

Apr 2025

Primary completion

Jan 31, 2028

Completion

Jan 31, 2030

Study Design

Enrollment

430 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Phase 1, monotherapy (Part 1A)
  Escalating doses of once daily, oral AVZO-021 in 28-day cycles.
• Experimental: Phase 1, combination (Parts 1B and 1C)
  Escalating doses of once daily, oral AVZO-021 in 28-day cycles starting at least 1 DL below the monotherapy MTD/RP2D dose in combination with: 1B1) fulvestrant 1B2) palbociclib plus either fulvestrant or letrozole 1B3) ribociclib plus either fulvestrant or letrozole 1B4) abemaciclib plus either fulvestrant or letrozole 1B5) sacituzumab govitecan-hziy 1C) carboplatin
• Experimental: Phase 2, monotherapy (Part 2A)
  Oral doses of AVZO-021 in 28-day cycles at the RP2D determined in Part 1A.
• Experimental: Phase 2, combination (Parts 2B and 2C)
  Oral doses of AVZO-021 in 28-day cycles at the RP2D determined in Parts 1B/1C, in combination with: 2B1) fulvestrant 2B2) palbociclib plus either fulvestrant or letrozole 2B3) ribociclib plus either fulvestrant or letrozole 2B4) abemaciclib plus either fulvestrant or letrozole 2B5) sacituzumab govitecan-hziy 2C) carboplatin

Primary Outcome Measure

Occurrence of Dose Limiting Toxicities (DLTs) during the first cycle (Phase 1) [ Time Frame: 28 Days ]

Central Contacts

• Medical Information
  (858) 239-2944
  [email protected]

Locations (11)

Find similar trials in New Haven, CT

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