Trial · NCT07491159
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | RP2D | From enrollment to the end of treatment at 4 week | Recommended phase 2 dose |
| Primary | Overall Survival (OS) | Up to 36 months | Time from randomization/enrollment to death from any cause |
| Secondary | Progress-free Survival (PFS) | Assessed every 8 weeks, up to 12 months | Time from randomization/enrollment to first documented disease progression (per RECIST v1.1) or death from any cause, whichever occurs first |
| Secondary | Objective Response Rate (ORR) | Tumor assessments performed at baseline, then every 8 weeks (±7 days) from the date of first dose until radiographic disease progression or death, assessed up to approximately 12 months | The proportion of patients who achieve a confirmed complete response (CR) or partial response (PR) as their best overall response, as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 |
| Secondary | Duration of Response (DoR) | Up to 12 months | Time from first documented response (CR/PR) to disease progression or death |
| Secondary | Incidence of AEs | by NCI-CTCAE v5.0. From first dose up to 30 days after last dose | Number and percentage of participants experiencing adverse events graded by NCI-CTCAE v5.0 |
| Secondary | Incidence of SAEs | From informed consent up to 30 days after last dose | Number and percentage of participants experiencing serious adverse events |
| Secondary | Number of participants with Laboratory abnormalities | From baseline up to 30 days after last dose | Incidence of clinically significant laboratory parameter changes per NCI-CTCAE v5.0 |
| Other | Biomarker Analysis for Efficacy Prediction | Baseline, during treatment (every 8 weeks), and at disease progression, up to 24 months | To explore potential predictive biomarkers associated with treatment efficacy, including: Blood-based biomarkers (CEA, CTCs, VEGF) |
| Other | Tumor tissue biomarkers (TMB, DNA methylation status) | Baseline, during treatment (every 8 weeks), and at disease progression, up to 24 months | Biomarker Analysis for Efficacy Prediction |
| Other | Clinical characteristics (sex, metastatic sites) | Baseline, during treatment (every 8 weeks), and at disease progression, up to 24 months |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT07491159/registered