Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2026-01-01 @ 2:29 AM
Study NCT ID:
NCT06994806
Status:
RECRUITING
Last Update Posted:
2025-07-11
First Post:
2025-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Investigate the Safety and Efficacy of KQB168 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies
Sponsor:
Kumquat Biosciences Inc.
Organization:
Study Overview
Official Title:
A Phase 1, Open-label, Multicenter, Dose Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of KQB168 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Malignancies
Status:
RECRUITING
Status Verified Date:
2025-07
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:
The goal of this clinical trial is to learn if KQB168 works to treat advanced solid tumor cancer in adults. It will also learn about the safety of KQB168. The main questions it aims to answer are:
* What is the safe dose of KQB168 by itself or in combination with pembrolizumab?
* Does KQB168 alone or in combination with pembrolizumab decrease the size of the tumor?
* What happens to KQB168 in the body?
Participants will:
* Take KQB168 daily, alone or in combination with pembrolizumab
* Visit the clinic about 8 times in the first 8 weeks, and then once every 3 weeks after that
* What is the safe dose of KQB168 by itself or in combination with pembrolizumab?
* Does KQB168 alone or in combination with pembrolizumab decrease the size of the tumor?
* What happens to KQB168 in the body?
Participants will:
* Take KQB168 daily, alone or in combination with pembrolizumab
* Visit the clinic about 8 times in the first 8 weeks, and then once every 3 weeks after that
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: