Trial · NCT06172478
A Study of HER3-DXd in Subjects With Locally Advanced or Metastatic Solid Tumors
NCT06172478, Phase 2, Recruiting, Daiichi Sankyo
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of HER3-DXd in Subjects With Locally Advanced or Metastatic Solid Tumors. Trials, record NCT06172478. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06172478
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of HER3-DXd in Subjects With Locally Advanced or Metastatic Solid Tumors
- NCT number
- NCT06172478
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 740 participants, estimated
- Lead sponsor
- Daiichi Sankyo
- Conditions
Advanced Solid Tumor, Melanoma, Head and Neck Cancer, Gastric Cancer, Ovarian Carcinoma, Cervical Cancer, Endometrial Cancer, Bladder Cancer, Esophageal Cancer, Pancreatic Carcinoma, Prostate Cancer, Non-small Cell Lung Cancer (NSCLC), Lung Cancer, Breast Cancer
- Interventions
- HER3-DXd
- First posted
- 2023-12-15
- Last updated
- 2026-10-26
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Objective Response Rate Assessed by Investigator Following HER3-DXd Monotherapy (All Cohorts Except Prostate Cancer Cohort) | Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 27 months | Confirmed objective response rate (ORR) is defined as the sum of the complete response (CR) rate and partial response (PR) rate based on investigator by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. |
| Primary | Proportion of Participants Achieving a ≥50% Decrease in PSA (Prostate Cancer Cohort Only) | Baseline, each cycle before infusion (each cycle is 21 days), and end of treatment, up to approximately 27 months | |
| Secondary | Overall Number of Participants With Treatment-emergent Adverse Events Following HER3-DXd Monotherapy (All Cohorts) | Baseline up to 27 months | Adverse events (AEs) will be coded using MedDRA and AEs and will be graded by using NCI-CTCAE v5.0. |
| Secondary | Duration of Response As Assessed by Investigator Following HER3-DXd Monotherapy (All Cohorts Except Prostate Cancer Cohort) | From the date of first documentation of confirmed response (CR or PR) to the first documentation of objective progression or to death due to any cause, whichever occurs first, up to approximately 27 months | Duration of response (DoR) is defined as the time from the date of the first documentation of objective response (complete response \[CR\] or partial response \[PR\]) to the date of the first documentation of progressive disease (PD) or death. The DoR will be calculated for responding participants (PR or CR) only. |
| Secondary | Clinical Benefit Rate As Assessed by Investigator Following HER3-DXd Monotherapy (All Cohorts Except Prostate Cancer Cohort) | Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 27 months | Clinical benefit rate (CBR) is the proportion of participants with a best overall response of confirmed CR, confirmed PR, or SD lasting ≥183 days. |
| Secondary | Disease Control Rate As Assessed by Investigator Following HER3-DXd Monotherapy (All Cohorts Except Prostate Cancer Cohort) | Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 27 months | Disease control rate is defined as the proportion of participants who have achieved a best overall response of confirmed CR, confirmed PR, or SD (or non-CR/non-PD) by investigator assessment per RECIST v1.1. |
| Secondary | Time to Response As Assessed by Investigator Following HER3-DXd Monotherapy (All Cohorts Except Prostate Cancer Cohort) | From the start date of study drug to the date of the first documentation of response (CR or PR) that is subsequently confirmed, up to approximately 27 months | Time to response (TTR) will be calculated for confirmed responders only. |
| Secondary | Progression-free Survival As Assessed by Investigator Following HER3-DXd Monotherapy (All Cohorts Except Prostate Cancer Cohort) | From the start date of study drug to the earlier date of the first objective documentation of radiographic disease progression as assessed by investigator per RECIST v1.1 or death due to any cause, whichever occurs first, up to approximately 27 months | |
| Secondary | Overall Survival Following HER3-DXd Monotherapy (All Cohorts) | From the start date of study drug to the date of death due to any cause, whichever occurs first, up to approximately 27 months | |
| Secondary | Pharmacokinetic Parameter Maximum Serum Concentration for HER3-DXd (All Cohorts) | Cycles 1-4, 6, 8: Day 1, predose and postdose; Cycles 1 and 3: Day 1, 2 hours and 4 hours postdose; Cycles 1 and 3: Day 8, Day 15 (each cycle is 21 days) | Maximum serum concentration (Cmax) will be assessed using non-compartmental methods. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41088723 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06172478
GET https://conductscience.org/api/trials/v1/NCT06172478/registered