Trial · NCT07908667
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 and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to approximately 24 months | Number of participants with AEs and SAEs, including changes in laboratory values, vital signs and echocardiograms (ECGs) qualifying and reported as AEs. |
| Primary | Incidence of Dose Limiting Toxicities (DLTs) | 21 days | Number of participants with DLTs. A DLT is defined as an adverse event or abnormal laboratory value of Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or higher, unless clearly and incontrovertibly assessed as due to underlying disease, disease progression, or intercurrent illness, that occurs within the first 21 days of treatment with TRB191. Other clinically significant toxicities may be considered DLTs, even if not CTCAE grade 3 or higher. |
| Primary | Frequency of dose interruptions and reductions | Up to approximately 24 months | Number of participants with dose adjustments (interruptions and reductions as a measure of tolerability. |
| Primary | Dose intensity | Up to approximately 24 months | Dose intensity defined as the ratio of actual cumulative dose received and actual duration of exposure. |
| Secondary | Maximum serum concentration (Cmax) of TRB191 | From pre-dose up to 120 or 240 hours post-dose | Pharmacokinetic (PK) parameters based on serum concentrations of TRB191. Cmax will be determined using non-compartmental method(s). |
| Secondary | Time to reach maximum serum concentration (Tmax) of TRB191 | From pre-dose up to 120 or 240 hours post-dose | PK parameters based on serum concentrations of TRB191. Tmax will be determined using non-compartmental method(s). |
| Secondary | Arean under the serum concentration-time curve (AUC) of TRB191 | From pre-dose up to 120 or 240 hours post-dose | PK parameters based on serum concentrations of TRB191. AUC will be determined using non-compartmental method(s). |
| Secondary | Number of participants with anti-drug antibodies (ADA) | From baseline (pre-dose) up to approximately 24 months | Number of participants with anti-TRB191 antibodies during treatment. |
| Secondary | Overall Response Rate (ORR) per RECIST v1.1 | Up to approximately 24 months | ORR is defined as the proportion of patients with a best overall response (BOR) of Complete response (CR) or Partial response (PR) as per local review and according to Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST v1.1). |
| Secondary | Disease Control Rate (DCR) per RECIST v1.1 | Up to approximately 24 months | DCR is defined as the proportion of patients with a BOR of CR, PR, or stable disease as per local review and according to RECIST v1.1. |
| Secondary | Duration of Response (DOR) per RECIST v1.1 | Up to approximately 24 months | DOR is the time between the first documented response (CR or PR) and the date of progression as per local review and according to RECIST v 1.1, or death due to any cause. |
| Secondary | Progression-Free Survival (PFS) per RECIST v1.1 | Up to approximately 24 months | PFS is defined as the time from the date of start of treatment to the date of the first documented progression as per local review and according to RECIST v1.1 or 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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT07908667/registered