Ignite Creation Date:
2024-05-06 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06172478
Status:
RECRUITING
Last Update Posted:
2024-05-31
First Post:
2023-12-07
Brief Title:
A Study of HER3-DXd in Subjects With Locally Advanced or Metastatic Solid Tumors
Sponsor:
Daiichi Sankyo
Organization:
Daiichi Sankyo
Study Overview
Official Title:
HERTHENA-PanTumor01 U31402-277 A Phase 2 Multicenter Multicohort Open-Label Proof of Concept Study of Patritumab Deruxtecan HER3-DXd U3-1402 in Subjects With Locally Advanced or Metastatic Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a proof-of-concept study designed to investigate HER3-DXd monotherapy in locally advanced or metastatic solid tumors The study is enrolling cohorts of participants with melanoma cutaneousacral squamous cell carcinomas of the head and neck SCCHN and HER2-negative gastric cancerovarian carcinoma cervical cancer endometrial cancer bladder cancer esophageal carcinoma pancreatic carcinoma and prostate cancer
Detailed Description:
This study is designed to assess the safety and efficacy of HER3-DXd monotherapy in subjects with refractory locally advanced or metastatic solid tumors who have been previously treated with 1 prior line of systemic anticancer therapy
The primary objective of the study is to assess the efficacy of HER3-DXd monotherapy for each type of indicated locally advanced or metastatic tumor Secondary objectives include the assessment of safety and tolerability efficacy and pharmacokinetics of HER3-DXd monotherapy for each type of indicated locally advanced or metastatic tumor HER3 protein expression in tumor tissue and its relationship with HER3-DXd efficacy will also be evaluated
The primary objective of the study is to assess the efficacy of HER3-DXd monotherapy for each type of indicated locally advanced or metastatic tumor Secondary objectives include the assessment of safety and tolerability efficacy and pharmacokinetics of HER3-DXd monotherapy for each type of indicated locally advanced or metastatic tumor HER3 protein expression in tumor tissue and its relationship with HER3-DXd efficacy will also be evaluated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| jRCT2031230575 | OTHER | jRCT | None |
| 2023-507641-29-00 | OTHER | None | None |