Trial · NCT04379596
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 25
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part 1: Occurrence of adverse events (AEs) and serious adverse events (SAEs), graded according to NCI CTCAE v5.0 | Safety will be assessed up to the follow-up period, approximately 24 months. | Occurrence of AEs and SAEs graded according to NCI CTCAE v5.0 |
| Primary | Part 1: Ocurrence of dose-limiting toxicities (DLTs) | Safety will be assessed up to the follow-up period, approximately 24 months. | Occurrence of dose limiting toxicities |
| Primary | Part 1: Changes from baseline in laboratory parameters | Safety will be assessed up to the follow-up period, approximately 24 months. | Changes in laboratory parameters (every in appropriate units) compared to baseline results. |
| Primary | Part 1: Changes from baseline in vital signs | Safety will be assessed up to the follow-up period, approximately 24 months. | Changes in vital signs results compared to baseline results. |
| Primary | Part 1: Changes from baseline in electrocardiogram (ECG) results | Safety will be assessed up to the follow-up period, approximately 24 months. | Changes in ECG results compared to baseline results. |
| Primary | Part 2, Part 3, Part 4 and Part 5: Endpoint assessed by Investigator per RECIST v1.1: Confirmed Objective Response Rate (ORR) | (Endpoint: ORR) Efficacy will be assessed at an average of approximately 12 months | Confirmed ORR per RECIST 1.1 is the percentage of patients with Complete Response or Partial Response that is subsequently confirmed. |
| Secondary | Part 1: Objective Response Rate (ORR) | Efficacy will be assessed at an average of approximately 12 months | Confirmed ORR per RECIST 1.1 is the percentage of patients with Complete Response or Partial Response that is subsequently confirmed. |
| Secondary | Part 2, Part 3, Part 4 and Part 5: Occurrence of adverse events (AEs) and serious adverse events (SAEs) | Safety will be assessed up to follow-up period, approximately 24 months | Occurrence of AEs and SAEs graded according to NCI CTCAE v5.0 |
| Secondary | Part 2, Part 3, Part 4 and Part 5: Changes from baseline in laboratory parameters | Safety will be assessed up to follow-up period, approximately 24 months | Changes in laboratory parameters (every in appropriate units) compared to baseline results. |
| Secondary | Part 2, Part 3, Part 4 and Part 5: Changes from baseline in vital signs | Safety will be assessed up to follow-up period, approximately 24 months | Changes in vital signs results compared to baseline results. |
| Secondary | Part 2, Part 3 , Part 4 and Part 5: Changes from baseline in body weight | Safety will be assessed up to follow-up period, approximately 24 months | Changes in body weight in kilograms compared to baseline results. |
| Secondary | Part 2, Part 3, Part 4 and Part 5: Changes from baseline in electrocardiogram (ECG) results | Safety will be assessed up to follow-up period, approximately 24 months | Changes in ECG results compared to baseline results. |
| Secondary | Duration of Response (DoR) | Until progression or death, efficacy (DoR) will be assessed up to approximately 24 months | DOR is defined as the time from the date of first documented response until the date of documented progression or death |
| Secondary | Disease Control Rate (DCR) | Efficacy will be assessed at an average of approximately 12 months | DCR is the percentage of subjects who have a best overall response of complete response (CR) or partial response (PR) or stable disease (SD) |
| Secondary | Progression Free Survival (PFS) | Until progression or death, efficacy (PFS) will be assessed up to approximately 24 months | PFS is the time from date of first dose until the date of objective disease progression or death |
| Secondary | Overall survival (OS) | Until death, efficacy (OS) will be assessed up to approximately 24 months | OS is the time from date of first dose until death due to any cause |
| Secondary | Serum concentration of T-DXd, total anti-HER2 antibody, and MAAA-1181a in all arms | While on study drug up to study completion, approximately 24 months | Individual participant data and descriptive statistics will be provided for serum concentration data at each time point for each dose level for T-DXd, total anti-HER2 antibody, MAAA-1181a |
| Secondary | Serum concentration of durvalumab in study arms including T-DXd in combination with durvalumab | While on study drug up to study completion, approximately 24 months | Individual participant data and descriptive statistics will be provided for serum concentration data at each time point for durvalumab. |
| Secondary | Presence of ADAs for T-DXD, durvalumab, volrustomig and rilvegostomig (in study arms including T-DXd and durvalumab, and T-DXd and volrustomig, and T-DXd and rilvegostomig respectively) | While on study drug up to study completion, approximately 24 months | Individual participant data and descriptive statistics will be provided for data at each time point for each dose level for T-DXd and durvalumab. |
| Secondary | Serum concentrations of volrustomig and rilvegostomig in study arms including T-DXd in combination with volrustomig and T-DXd in combination with rilvegostomig | While on study drug up to study completion, approximately 24 months | Individual participant data and descriptive statistics will be provided for data at each time point for rilvegostomig and volrustomig |
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.
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