Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT05867251 · ClinicalTrials.gov registry record · Phase 1

Study of AVZO-021 in Patients With Advanced Solid Tumors

A Phase 1 study of Advanced Solid Tumor and Endometrial Cancer, sponsored by Avenzo Therapeutics.

Recruiting
Registry status
Phase 1
Development phase
430
Enrollment target
13
Study locations

NCT05867251: Recruiting Phase 1 study of Advanced Solid Tumor and Endometrial Cancer, sponsored by Avenzo Therapeutics.

NCT05867251 is a Phase 1 study of Advanced Solid Tumor and Endometrial Cancer that is actively recruiting participants, run by Avenzo Therapeutics. The registered enrollment target is 430 participants, above the 191-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (125% higher). The trial reports 13 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT05867251, a Phase 1 study of Advanced Solid Tumor and Endometrial Cancer, is actively recruiting participants, sponsored by Avenzo Therapeutics.

RECRUITING
Registry status
Phase 1
Development phase
430 participants
Enrollment target
13
Study locations

Study Summary

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).

Primary Outcome

Number of participants with DLTs assessed for severity using CTCAE v5.0 criteria will be summarized by dose level.

Conditions Studied

Advanced Solid Tumor Endometrial Cancer Fallopian Tube Cancer Epithelial Ovarian Cancer Primary Peritoneal Cancer TNBC - Triple-Negative Breast Cancer HR+ HER2- Breast Cancer HR+, HER2-, Advanced Breast Cancer CCNE1 Amplification

Interventions

  • DRUG Letrozole
  • DRUG Fulvestrant
  • DRUG Palbociclib
  • DRUG AVZO-021
  • DRUG Ribociclib

Study Locations (13)

Florida

  • Florida Cancer Specialists - Sarasota
  • Moffitt Cancer Center - Tampa

New York

  • Perlmutter Cancer Center at NYU Langone Hospital - Long Island - Mineola
  • NYU Langone Medical Center (Tisch Hospital) - New York

New South Wales

  • Macquarie University Hospital - Macquarie University
  • Cancer Care Wollongong - Wollongong

Connecticut

  • Yale Cancer Center - New Haven

Ohio

  • University Hospitals Cleveland Medical Center - Cleveland

Oklahoma

  • Oklahoma University - Oklahoma City

Oregon

  • Providence Cancer Institute - Portland

Pennsylvania

  • Sidney Kimmel Cancer Center (SKCC) at Jefferson Health - Philadelphia

Trial Details

FieldValue
Enrollment Target 430 participants
Start Date 2023-08-30
Est. Completion 2030-01-31
Phase Phase 1
Avenzo Therapeutics

4 total trials

What NCT05867251 shows while recruiting

NCT05867251 is an interventional study that assigns participants to a tested intervention. The registered 430 participants enrollment target is mid-sized for trials with a published cap, above the 191-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (125% higher).

The record links to 9 conditions, with Advanced Solid Tumor appearing as the primary indexed condition, and to 5 interventions - of which Letrozole is the first listed.

NCT05867251 lists 13 locations in 10 states (Florida, New York, New South Wales).

Frequently Asked Questions

What is clinical trial NCT05867251 about?

NCT05867251 is a clinical study titled "Study of AVZO-021 in Patients With Advanced Solid Tumors". 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 ...

What is the current status of trial NCT05867251?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 430 participants. The study started on 2023-08-30. Estimated completion is 2030-01-31.

What conditions does trial NCT05867251 study?

This clinical trial studies the following conditions: Advanced Solid Tumor, Endometrial Cancer, Fallopian Tube Cancer, Epithelial Ovarian Cancer, Primary Peritoneal Cancer.

What interventions are being tested in trial NCT05867251?

The interventions under investigation include: Letrozole (DRUG), Fulvestrant (DRUG), Palbociclib (DRUG), AVZO-021 (DRUG), Ribociclib (DRUG).

Who is sponsoring clinical trial NCT05867251?

This trial is sponsored by Avenzo Therapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05867251 being conducted?

This trial has 13 study locations across Connecticut, Florida, New York, Ohio, Oklahoma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Advanced Solid Tumor

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05867251's enrollment target sits among peer trials

430 15th of 189 higher than 175 of 189 other Advanced Solid Tumor trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Advanced Solid Tumor trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT05327023 · 430 participants · Phase 1

    Donor Lymphocyte Infusion After Allogeneic Hematopoietic Cell Transplantation for High-Risk Hematologic Malignancies

  • NCT05457985 · 430 participants · NA

    Testing Adaptive Interventions to Improve Posttraumatic Stress Disorder Treatment Outcomes in Federally Qualified Health Centers

  • NCT05532982 · 430 participants

    Parkinson's Disease in Asian Americans

  • NCT05844891 · 430 participants · NA

    Telehealth-Enhanced Asthma Care for Home After the Emergency Room

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

More recruiting context for NCT05867251

Source: ClinicalTrials.gov NCT05867251, the US trial registry maintained by the National Library of Medicine. NCT05867251 (mid enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.