Trial · NCT07012031
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Dose-limiting toxicities of combined trastuzumab deruxtecan (DS-8201a) and sotorasib (AMG-510) treatment (Phase I) | Within the first 21 days of treatment initiation | Will be defined as an adverse event (AE) that is at least possibly related to the study treatment. Severity will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. |
| Primary | Overall response rate (ORR) (Phase II) | Up to 5 years | Will be defined as the proportion of patients with a confirmed response as per investigator assessment according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. Will be plotted using Kaplan-Meier method. |
| Secondary | Maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of trastuzumab deruxtecan (DS-8201a) and sotorasib (AMG-510) combination (Phase I) | Up to 5 years | Will be determined based on the totality of safety, tolerability, and clinical activity data as appropriate. RP2D nay be determined to be the highest dose level, the MTD, or it may be a lower dose based on the consensus of the investigators, Cancer Therapy Evaluation Program, and pharmaceutical company collaborators. |
| Secondary | ORR (Phase I) | Up to 5 years | Will be defined as the proportion of patients with a confirmed response (i.e., response confirmed by a second radiographic evaluation) as per investigator assessment according to RECIST v 1.1. Will be summarized using both a point estimate and its exact 95% confidence interval based on the binomial distribution. |
| Secondary | Progression-free survival (PFS) (Phase II) | From start of treatment to disease progression or death due to any cause, assessed up to 5 years | Will be plotted using Kaplan-Meier method. |
| Secondary | Duration of response (Phase II) | From the time measurement criteria are first met for complete response or partial response until the first date that recurrent or progressive disease is objectively documented, assessed up to 5 years | Will be plotted using Kaplan-Meier method. |
| Secondary | Overall survival (OS) (Phase II) | From first treatment to time of death due to any cause, assessed up to 5 years | Will be plotted using Kaplan-Meier method. |
| Secondary | Incidence of AEs (Phase II) | Up to 30 days after the last dose of study drug | Will be tabulated by grade. AEs will be described and graded using NCI CTCAE v 5.0. |
| Secondary | Rate of ERBB2/ERBB3 gene overexpression (Phase II) | At pre-treatment | Gene expression levels will be measured by counts (i.e., by the number of reads mapped on each gene). Data analysis will be descriptive statistics in nature (e.g., proportion of ERBB2/ERBB3 gene expression in each response group). |
| Secondary | Correlation between ERBB2 gene expression in pre-treatment specimens and the treatment response (Phase II) | Up to 5 years | Will be measured by ribonucleic acid (RNA)-Sequencing. |
| Other | Correlation between HER2 immunohistochemistry (IHC) archival and pre-treatment (study biopsy) results and ORR, PFS, and OS (Phase II) | Up to 5 years | Data analysis will be descriptive statistics in nature (e.g., proportion of IHC+ or proportion of overexpressed in each response group). |
| Other | Correlation between ERBB2 gene expression and ORR, PFS, and OS (Phase II) | Up to 5 years | Will be measured by RNA Salah Targeted Expression Panel and mass spectrometry. |
| Other | Correlation between circulating tumor deoxyribonucleic acid (ctDNA) clearance and ORR, PFS, and OS (Phase II) | Up to 5 years | Kaplan Meier method will be used to estimate the median PFS and OS for the ctDNA clearance and non-clearance groups. |
| Other | Whole exome sequencing (WES) (Phase II) | Up to 5 years | |
| Other | Correlation between WES and response rate, PFS, and OS (Phase II) | Up to 5 years | |
| Other | Pharmacokinetics of trastuzumab deruxtecan (DS-8201a) (Phase II) | Before trastuzumab deruxtecan (DS-8201a) infusion and within 30 minutes of the end of infusion on cycle (c) 1 day (d) 1, C2D1, C4D1, and C6D1 | |
| Other | Pharmacokinetics of sotorasib (AMG-510) (Phase II) | Before sotorasib dose and trastuzumab deruxtecan (DS-8201a) infusion on C1D1, C2D1, C6D1 and within 30 minutes of the end of DS-8201a (T-DXd) infusion on C1D1 and C2D1 | |
| Other | Antidrug antibodies against trastuzumab deruxtecan (DS-8201a) (Phase II) | Before trastuzumab deruxtecan (DS-8201a) infusion on C1D1, C2D1, C4D1, C6D1 and at the end of treatment visit |
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
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GET https://conductscience.org/api/trials/v1/NCT07012031/registered