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A Study to Investigate the Safety and Efficacy of KQB168 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies

RECRUITINGPhase 1Sponsored by Kumquat Biosciences Inc.
Actively Recruiting
PhasePhase 1
SponsorKumquat Biosciences Inc.
Started2025-06-24
Est. completion2027-11-30
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations4 sites

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

Eligibility

Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria:

* Histologically confirmed diagnosis of solid tumor malignancy.
* Unresectable or metastatic disease that has progressed on immunotherapy.
* No available treatment with curative intent
* Adequate organ function
* Measurable disease per RECIST v1.1

Exclusion Criteria:

* Active primary central nervous system tumors
* Cardiac abnormalities
* History of lung diseases
* Any condition that may impair drug absorption or prevent oral dosing
* Known history of immune-mediated colitis and uncontrolled autoimmune diseases

Conditions2

CancerSolid Tumor Malignancies

Locations4 sites

Texas

3 sites
NEXT Austin
Austin, Texas, 78758
Heather Watson737-610-5202hwatson@nextoncology.com
NEXT Huston
Houston, Texas, 77054
Emma Morales(832) 384-7912emorales@nextoncology.com
NEXT Oncology
San Antonio, Texas, 78229
Jordan Georg(210) 580-9521jgeorg@nextoncology.com

Virginia

1 site
NEXT Virginia
Fairfax, Virginia, 22031
Referral Coordinator(703) 783-4518mdelarosa@nextoncology.com

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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