Ignite Creation Date:
2024-05-06 @ 2:34 PM
Last Modification Date:
2024-10-26 @ 1:33 PM
Study NCT ID:
NCT04363801
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-22
First Post:
2020-04-23
Brief Title:
A Study of DKN-01 in Combination With Tislelizumab Chemotherapy in Patients With Gastric or Gastroesophageal Cancer
Sponsor:
Leap Therapeutics Inc
Organization:
Leap Therapeutics Inc
Study Overview
Official Title:
A Phase 2 Multicenter Open-Label Study of DKN-01 in Combination With Tislelizumab Chemotherapy as First-Line or Second-Line Therapy in Adult Patients With Inoperable Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma DisTinGuish
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01
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:
DisTinGuish
Brief Summary:
A Phase 2 Multicenter Open-Label Study of DKN-01 in Combination with Tislelizumab Chemotherapy as First-Line or Second-Line Therapy in Adult Patients with Inoperable Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
Detailed Description:
This is a Phase 2 open-label multicenter study to be conducted concurrently in 3 Parts Parts A B and C Approximately 232 patients aged 18 years or older with inoperable histologically confirmed locally advanced or metastatic GGEJ adenocarcinoma with measurable disease RECIST v11 requiring therapy will be enrolled in the study Part A and B are designed to evaluate safety tolerability and efficacy of the combination therapy of intravenous IV DKN-01 and tislelizumab CAPOX in GGEJ adenocarcinoma patients Treatment continues in repeating 21-day cycles until patient meets criteria for discontinuation or is no longer deriving clinical benefit Two doses of DKN-01 will be evaluated in Part B Part B1 and Part B2 Part C is the open-label randomized controlled 2-arm portion of the study to evaluate the efficacy and safety of tislelizumab chemotherapy regimen CAPOX or mFOLFOX6 DKN-01 in adult patients with inoperable histologically confirmed locally advanced or metastatic GGEJ adenocarcinoma with measurable disease RECIST v11 requiring therapy Approximately 160 patients will be randomized in a 11 ratio to receive either DKN-01 in combination with tislelizumab and chemotherapy regimen CAPOX or mFOLFOX6 n80 or tislelizumab in combination with chemotherapy regimen CAPOX or mFOLFOX6 n80
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