Trial · NCT05867251
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| 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) | |
| Secondary | PK Parameters: Area under the plasma concentration-time curve from time 0 to last measurable concentration (AUC 0-tau) (monotherapy and combination) | Cycle 1 days 1, 2, 8, 14, and 15 (each cycle is 28 days) | |
| Secondary | PK Parameters: Minimum observed plasma concentration at steady state (Cmin, ss) (monotherapy and combination) | Cycle 1 days 1, 2, 8, 14, and 15 (each cycle is 28 days) | |
| Secondary | PK Parameters: Accumulation ration (Rac) (monotherapy and combination) | Cycle 1 days 1, 2, 8, 14, and 15 (each cycle is 28 days) | |
| Secondary | PK Parameters: Elimination half-life (t1/2) (monotherapy and combination) | Cycle 1 days 1, 2, 8, 14, and 15 (each cycle is 28 days) | |
| Secondary | PK Parameters: Apparent clearance (CL/F) (monotherapy and combination) | Cycle 1 days 1, 2, 8, 14, and 15 (each cycle is 28 days) | |
| Secondary | PK Parameters: Apparent volume of distribution during terminal phase (Vz/F) (monotherapy and combination) | Cycle 1 days 1, 2, 8, 14, and 15 (each cycle is 28 days) | |
| Secondary | Evaluate the effect of a high-fat meal on the PK of AVZO-021 (Phase 1) | 5 days |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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