Trial · NCT06873763
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of DLT | up to 6 months | Status of DLT will be presented with frequency, percentage and its 95% confidence interval (CI). |
| Primary | RP2D(Recommended Phase 2 Dose) | up to 2 years | The recommended phase 2 dose (RP2D) of nelmastobart in combination with trifluridine/tipiracil and bevacizumab |
| Primary | MTD(Maximum Tolerated Dose) | up to 2 years | To find the maximum tolerated dose (MTD) |
| Primary | Progression Free Survival (PFS) rate | up to 2 years | Time from the start of treatment to objective tumor progression or all-cause death will be presented with survival curve, median survival time and its 95% CI using the Kaplan-Meier estimation. |
| Secondary | Phase 2 study; Overall Survival (OS) | up to 2 years | Time from the start of treatment to all cause death |
| Secondary | Phase 2 study; Objective Response Rate (ORR) | up to 2 years | Investigator assessed ORR defined by RECIST 1.1 or iRECIST |
| Secondary | Maximum plasma concentration (Cmax) | up to 6 months | Maximum plasma concentration of Nelmastobart to evaluate PK parameters |
| Secondary | Phase 2 study; Disease Control Rate (DCR) | up to 2 years | Investigator assessed DCR at 16 weeks defined by RECIST 1.1 or iRECIST |
| Secondary | PFS(Progression free survival) | up to 2 years | Time from first dose until the date of objective disease progression or death |
| Secondary | Phase 2 study; Duration of Response (DOR) | up to 2 years | Time from the date of first confirmed objective response (CR or PR) after investigational drug administration to the first documented disease progression (PD) or death from any cause, with documentation of disease progression status and cause of death |
| Secondary | AEs(Adverse Events) | up to 2 years | Status of AEs will be presented with frequency, percentage and its 95% CI. AEs will be classified by SOC and PT of MedDRA (latest version) and presented with frequency, percentage and its 95% CI. |
| Secondary | Tmax(Time to Maximum Plasma Concentration) | up to 2 years | Time to reach Tmax of Nelmastobart to evaluate the PK parameters. |
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/NCT06873763/registered