Trial · NCT07002177
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase Ib- Dose-Limiting Toxicity (DLT). | Approximately 1.5 years | |
| Primary | Phase Ib- Maximum Tolerated Dose (MTD). | Approximately 1.5 years | |
| Primary | Phase Ib- Recommended Phase II Dose (RP2D). | Approximately 1.5 years | |
| Primary | Incidence of Treatment-Emergent Adverse Events (TEAEs) | Approximately 2 years | Number and proportion of participants experiencing any treatment-emergent adverse event during the study period. Assessment criteria: Events will be categorized as "related" or "unrelated" to study drug based on investigator's causality assessment. Reporting format: Frequency counts and percentages stratified by severity grade (Grade 1-5 as per NCI-CTCAE v5.0). |
| Primary | Severity Grading of Adverse Events | Approximately 2 years | Maximum severity grade of treatment-emergent adverse events experienced by participants. Assessment tool: National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Reporting format: Proportion of participants with events in each severity category (Grade 1=mild; Grade 2=moderate; Grade 3=severe; Grade 4=life-threatening; Grade 5=death). |
| Primary | Clinically Significant Abnormalities in 12-Lead ECG Parameters | Approximately 2 years | Number of participants with clinically significant changes in electrocardiogram parameters from baseline. Assessed parameters: QTc interval, PR interval, QRS duration, heart rate. |
| Primary | Vital Sign Abnormalities | Approximately 2 years | Proportion of participants with clinically significant deviations in vital signs: Parameters: Systolic/diastolic blood pressure (mmHg), heart rate (bpm), respiratory rate (breaths/min), body temperature (°C). |
| Primary | Serious Adverse Events (SAEs) Incidence | Approximately 2 years | |
| Primary | Phase II- Investigator-assessed Objective Response Rate (ORR) based on RECIST v1.1. | Approximately 2 years | |
| Secondary | Phase Ib- PK Assessment-Tmax | Approximately 1.5 years | Time to Cmax (Tmax). |
| Secondary | Phase Ib- PK Assessment-Cmax | Approximately 1.5 years | Maximum plasma concentration (Cmax) |
| Secondary | Phase Ib- PK Assessment-AUC0-t | Approximately 1.5 years | Area under the concentration versus time curve from time 0 to the last measurable concentration (AUC0-t) |
| Secondary | Phase Ib- PK Assessment-AUC0-inf | Approximately 1.5 years | The area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC0-inf) |
| Secondary | Phase Ib- PK Assessment-t1/2 | Approximately 1.5 years | elimination half-life time (t1/2) |
| Secondary | Efficacy Assessment-ORR | Approximately 2 years | Tumor response assessments by the corresponding criteria by RECIST v1.1 to assess Objective response rate (ORR) |
| Secondary | Efficacy Assessment-CBR | Approximately 2 years | Clinical benefit rate (CBR) |
| Secondary | Efficacy Assessment-DOR | Approximately 2 years | Duration of response (DoR） |
| Secondary | Efficacy Assessment-DCR | Approximately 1.5 years | Disease control rate (DCR) |
| Secondary | Efficacy Assessment-PFS | Approximately 2 years | Progression-free survival (PFS) by IRC according to RECIST 1.1.PFS is defined as time from the first dose until disease progression or death from any cause, whichever occurs first. |
| Secondary | Efficacy Assessment-OS | Approximately 2 years | Overall survival (OS).OS is defined as time from date of the first dose to date of death due to any cause. |
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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