RECRUITING

Study of AVZO-021 in Patients With Advanced Solid Tumors

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

A Phase 1/2, First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of AVZO-021 as a Single Agent and in Combination Therapy in Patients With Advanced Solid Tumors

Quick Facts

Study Start:2023-08-30

Study Completion:2030-01-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05867251

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Male or female aged ≥18 years old at screening with Eastern Cooperative Oncology Group (ECOG) 0-1. 2. Disease-related inclusion criteria by study phase and part: 3. No more than 2 prior cytotoxic chemotherapy regimens for locally advanced/metastatic disease (prior chemotherapy in the adjuvant or neoadjuvant setting allowed if \>12 months prior to starting AVZO-021 treatment and is not considered a prior line). 4. Measurable disease as determined by RECIST version 1.1. 5. Adequate bone marrow and organ function. 6. Ability to swallow capsules or tablets.	1. Received an investigational agent or anticancer therapy within 2 weeks, or 5 half-lives of the drug, whichever is shorter, prior to planned start of AVZO-021. 2. Received any CDK2 inhibitor, protein kinase membrane associated tyrosine/threonine 1 (PKMYT1) inhibitor, or WEE1 inhibitor anticancer therapy. 3. Undergone major surgery within 4 weeks prior to planned start of AVZO-021. 4. Received radiotherapy for palliation within 7 days of the first dose of study treatment, unless specified otherwise in the protocol. 5. Active CNS metastases or confirmed leptomeningeal disease are not eligible. 6. Unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grade \>1 at the time of starting study treatment. 7. Clinically unstable cardiac function as described in the protocol. 8. Any active or chronic infection/disease that compromises the immune system. 9. Current treatment with strong or moderate cytochrome P450 (CYP)3A4 inhibitors or inducers. 10. Active second malignancy unless in remission with life expectancy \> 2 years and with documented sponsor approval. 11. Pregnancy, lactation, or plans to breastfeed during the study or within 6 months of the last dose of study intervention.

Inclusion Criteria

Exclusion Criteria

1. Male or female aged ≥18 years old at screening with Eastern Cooperative Oncology Group (ECOG) 0-1.
2. Disease-related inclusion criteria by study phase and part:
3. No more than 2 prior cytotoxic chemotherapy regimens for locally advanced/metastatic disease (prior chemotherapy in the adjuvant or neoadjuvant setting allowed if \>12 months prior to starting AVZO-021 treatment and is not considered a prior line).
4. Measurable disease as determined by RECIST version 1.1.
5. Adequate bone marrow and organ function.
6. Ability to swallow capsules or tablets.

1. Received an investigational agent or anticancer therapy within 2 weeks, or 5 half-lives of the drug, whichever is shorter, prior to planned start of AVZO-021.
2. Received any CDK2 inhibitor, protein kinase membrane associated tyrosine/threonine 1 (PKMYT1) inhibitor, or WEE1 inhibitor anticancer therapy.
3. Undergone major surgery within 4 weeks prior to planned start of AVZO-021.
4. Received radiotherapy for palliation within 7 days of the first dose of study treatment, unless specified otherwise in the protocol.
5. Active CNS metastases or confirmed leptomeningeal disease are not eligible.
6. Unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grade \>1 at the time of starting study treatment.
7. Clinically unstable cardiac function as described in the protocol.
8. Any active or chronic infection/disease that compromises the immune system.
9. Current treatment with strong or moderate cytochrome P450 (CYP)3A4 inhibitors or inducers.
10. Active second malignancy unless in remission with life expectancy \> 2 years and with documented sponsor approval.
11. Pregnancy, lactation, or plans to breastfeed during the study or within 6 months of the last dose of study intervention.

Contacts and Locations

Study Contact

Medical Information

CONTACT

(858) 239-2944

ClinicalTrials@avenzotx.com

Study Locations (Sites)

Yale Cancer Center

New Haven, Connecticut, 06520

United States

Florida Cancer Specialists

Sarasota, Florida, 34232

United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106

United States

Oklahoma University

Oklahoma City, Oklahoma, 73117

United States

Sidney Kimmel Cancer Center (SKCC) at Jefferson Health

Philadelphia, Pennsylvania, 19107

United States

NEXT Virginia

Fairfax, Virginia, 22031

United States

Collaborators and Investigators

Sponsor: Avenzo Therapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-30

Study Completion Date2030-01-31

Study Record Updates

Study Start Date2023-08-30

Study Completion Date2030-01-31

Terms related to this study

Additional Relevant MeSH Terms

Advanced Solid Tumor