Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06266299
Status:
RECRUITING
Last Update Posted:
2024-04-26
First Post:
2024-02-05
Brief Title:
A Study of KK2269 in Adult Participants With Solid Tumors
Sponsor:
Kyowa Kirin Inc
Organization:
Kyowa Kirin Co Ltd
Study Overview
Official Title:
A Phase 1 Multicenter Open-label Dose-escalation Study Evaluating the Safety and Tolerability of Intravenous KK2269 Monotherapy and Combination Therapy With Docetaxel in Adult Participants With Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-04
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 first-in-human study of KK2269 Part 1 and Part 2 will be conducted as a multicenter open-label non-randomized dose-escalation study Participants with advanced or metastatic solid tumors for which no standard therapy is available will be enrolled in Part 1 In Part 1 the primary objective is to assess the safety and tolerability of KK2269
In Part 2 only participants with gastric adenocarcinoma GEJ adenocarcinoma esophageal adenocarcinoma or NSCLC who have experienced at least one systemic therapy will be enrolled In Part 2 the primary objective is to assess the safety and tolerability of KK2269 in combination with docetaxel and to determine the recommended doses and dose intervals of KK2269 in combination with docetaxel for subsequent studies
In both Part 1 and Part 2 participants who refuse to undergo standard therapy are also eligible
In Part 2 only participants with gastric adenocarcinoma GEJ adenocarcinoma esophageal adenocarcinoma or NSCLC who have experienced at least one systemic therapy will be enrolled In Part 2 the primary objective is to assess the safety and tolerability of KK2269 in combination with docetaxel and to determine the recommended doses and dose intervals of KK2269 in combination with docetaxel for subsequent studies
In both Part 1 and Part 2 participants who refuse to undergo standard therapy are also eligible
Detailed Description:
None
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