Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06330064
Status:
RECRUITING
Last Update Posted:
2024-04-16
First Post:
2024-03-19
Brief Title:
A Study To Evaluate The Efficacy And Safety Of Ifinatamab Deruxtecan I-DXd In Subjects With Recurrent Or Metastatic Solid Tumors IDeate-PanTumor02
Sponsor:
Daiichi Sankyo
Organization:
Daiichi Sankyo
Study Overview
Official Title:
A Phase 1B2 Pan-Tumor Open-Label Study To Evaluate The Efficacy And Safety Of Ifinatamab Deruxtecan I-DXd In Subjects With Recurrent Or Metastatic Solid Tumors IDeate-PanTumor02
Status:
RECRUITING
Status Verified Date:
2024-10
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 study is designed to assess the efficacy and safety of ifinatamab deruxtecan I-DXD in the following tumor types endometrial cancer EC head and neck squamous cell carcinoma HNSCC pancreatic ductal adenocarcinoma PDAC colorectal cancer CRC hepatocellular carcinoma HCC adenocarcinoma of esophagus gastroesophageal junction and stomach Ad-EsoGEJgastric urothelial carcinoma UC ovarian cancer OVC cervical cancer CC biliary tract cancer BTC human epidermal growth factor 2 HER2-low breast cancer BC HER2 immunohistochemistry IHC 0 BC and cutaneous melanoma
Detailed Description:
This study will evaluate the efficacy and safety of I-DXd in participants with recurrent or metastatic solid tumors previously treated with 1 or more systemic therapies for the selected tumor indication The study will be divided into 2 parts Stage 1 and Stage 2 Each cohort starts with Stage 1 and may continue to Stage 2 if sufficient safety and efficacy data are observed
The HCC Safety Run-In Phase 1 will assess the safety and tolerability of I-DXd and will assess the maximum tolerated dose MTD Once the MTD is established participants with HCC will be further treated with this dose of I-DXd
The HCC Safety Run-In Phase 1 will assess the safety and tolerability of I-DXd and will assess the maximum tolerated dose MTD Once the MTD is established participants with HCC will be further treated with this dose of I-DXd
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 |
|---|---|---|---|
| 2023-509632-26 | OTHER | EU CTR | None |