Trial · NCT05867251
Study of AVZO-021 in Patients With Advanced Solid Tumors
NCT05867251, Phase 1, Phase 2, Recruiting, Avenzo Therapeutics, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of AVZO-021 in Patients With Advanced Solid Tumors. Trials, record NCT05867251. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05867251
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of AVZO-021 in Patients With Advanced Solid Tumors
- NCT number
- NCT05867251
- Status
- Recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 430 participants, estimated
- Lead sponsor
- Avenzo Therapeutics, Inc.
- Conditions
Advanced Solid Tumor, HR+/HER2- Breast Cancer, HR+, HER2-, Advanced Breast Cancer, CCNE1 Amplification, Epithelial Ovarian Cancer, Primary Peritoneal Cancer, Fallopian Tube Cancer, Endometrial Cancer, TNBC - Triple-Negative Breast Cancer
- Interventions
- AVZO-021, Palbociclib, Fulvestrant, Letrozole, Ribociclib, Abemaciclib, Carboplatin, Sacituzumab Govitecan-hziy
- First posted
- 2023-05-19
- Last updated
- 2026-09-28
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Occurrence of Dose Limiting Toxicities (DLTs) during the first cycle (Phase 1) | 28 Days | Number of participants with DLTs assessed for severity using CTCAE v5.0 criteria will be summarized by dose level. |
| Primary | Number of Participants with Treatment Emergent Adverse Events (TEAEs) and lab abnormalities (Phase 1) | Approximately 22 months | To evaluate the type, incidence, severity, timing, seriousness, and relationship to study treatment of adverse events and any laboratory abnormalities summarized by dose level. |
| Primary | Determination of Recommended Phase 2 Dose (RP2D) (Phase 1) | Approximately 16 months | RP2D for AVZO-021 is less than or the same as the maximum tolerated dose (MTD) as defined by the occurrence of DLTs and TEAEs calculated using isotonic regression. |
| Primary | Objective Response Rate (ORR) (Phase 2) | Approximately 52 months | Defined as the proportion of patients with a confirmed Complete Response (CR) or Partial Response (PR), as determined by the investigator by radiographic disease assessment according to RECIST v1.1. |
| Primary | Progression Free Survival (PFS) (Phase 2) | Approximately 52 months | Defined as the time from study drug treatment to death or disease progression, as determined by the investigator by radiographic disease assessment according to RECIST v1.1. |
| Primary | Overall Survival (OS) (Phase 2) | Approximately 76 months | Defined as the time from study drug treatment initiation to death from any cause. |
| Primary | Duration of response (DOR) (Phase 2) | Approximately 52 months | Defined as the time from the first confirmed response to radiologic/objective progression. |
| Secondary | PK Parameters: Maximum plasma concentration (Cmax) (monotherapy and combination) | Cycle 1 days 1, 2, 8, 14, and 15 (each cycle is 28 days) | |
| Secondary | PK Parameters: Time to maximum plasma concentration (Tmax) (monotherapy and combination) | Cycle 1 days 1, 2, 8, 14, and 15 (each cycle is 28 days) | |
| Secondary | PK Parameters: Area under the plasma concentration-time curve from time 0 to last measurable concentration (AUC 0-last) (monotherapy and combination) | Cycle 1 days 1, 2, 8, 14, and 15 (each cycle is 28 days) |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05867251
GET https://conductscience.org/api/trials/v1/NCT05867251/registered