Trial · NCT07756593
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 | Frequency of dose-limiting toxicities (Cohort 1 only) | Start of treatment (day 1 dose of Sip-T) through 14 days following the last dose of N-803 (total time up to 44 days) | As assessed via CTCAE v6.0. Dose limiting toxicities will be evaluated according to protocol. |
| Primary | Recommended Phase II Dose (RP2D) (Cohort 1 only) | Start of treatment (day 1 dose of Sip-T) through 14 days following the last dose of N-803 for all participants in Cohort 1 (total time up to 44 days) | RP2D is defined as the highest dose of N-803 that has an overall DLT rate of less than 33% in total of 6 patients. |
| Primary | Number of severe (grade 3+) adverse events measured via CTCAE v6.0 | Start of treatment through 100 days after last dose of N-803 (total time up to 137 days) | |
| Primary | Number and type of adverse events measured via CTCAE v6.0 | Start of treatment through 100 days after last dose of N-803 (total time up to 137 days) | |
| Secondary | PSA30 Response | Start of treatment to completion of follow-up (up to 26 months) | PSA response rate is defined as the proportion of subjects who have PSA response as defined by at least 30% reduction in PSA level from baseline measured twice at least 3 weeks apart. PSA response is measured per PCWG3 criteria. |
| Secondary | PSA50 Response | Start of treatment to completion of follow-up (up to 26 months) | PSA response rate is defined as the proportion of subjects who have PSA response as defined by at least 50% reduction in PSA level from baseline measured twice at least 3 weeks apart. PSA response is measured per PCWG3 criteria. |
| Secondary | PSA90 Response | Start of treatment to completion of follow-up (up to 26 months) | PSA response rate is defined as the proportion of subjects who have PSA response as defined by at least 90% reduction in PSA level from baseline measured twice at least 3 weeks apart. PSA response is measured per PCWG3 criteria. |
| Secondary | Radiographic progression-free survival (PFS) | Start of treatment to date of progression or death or last follow-up (up to 26 months) | rPFS is defined as the duration of time from start of treatment to time of radiographic progression by PCWG3 or time of death or last follow-up, the event that occurs first. Patients who have not experienced either event at the time of analysis will be censored at their last radiographic scan date. All radiographic response criteria are assessed per PCWG3 criteria. |
| Secondary | Failure-free survival (FFS) | Start of treatment to date of any progression events or last follow-up (up to 26 months) | Failure-free survival which is defined from date of treatment start to date of any progression events (radiographic progression, biochemical recurrence, or death, whichever is earlier) or date of last follow-up if experiencing no events |
| Secondary | Time to next therapy (TTNT) | Through completion of follow-up (up to 26 months) | |
| Secondary | Overall survival (OS) | Start of treatment to death or last follow-up (up to 26 months) | Overall survival is defined as the date of treatment start to date of death or date of last follow-up. |
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.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT07756593/registered