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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
Trial Status: active
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
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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06994806.