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

Recruiting now · Phase 1

Conditions studied: Solid Tumor Malignancies

In brief

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

Key facts

Study ID

NCT06994806

Run by

Kumquat Biosciences Inc.

People needed

84

Starts

2025-06-24

Expected to finish

2028-05-31

Last updated by the study team

2026-03-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Mayo Clinic - Phoenix — Phoenix, Arizona, United States (enrolling)
• USC Norris Comprehensive Cancer Center — Los Angeles, California, United States (enrolling)
• Sarah Cannon Cancer Institute at HealthONE — Denver, Colorado, United States (enrolling)
• Yale Cancer Center- New Haven — New Haven, Connecticut, United States (enrolling)
• Mayo Clinic - Jacksonville — Jacksonville, Florida, United States (enrolling)
• Florida Cancer Specialists - Sarasota — Sarasota, Florida, United States (enrolling)
• University of Iowa — Iowa City, Iowa, United States (enrolling)
• Mayo Clinic - Rochester — Rochester, Minnesota, United States (enrolling)
• Cleveland Clinic — Cleveland, Ohio, United States (enrolling)
• NEXT Austin — Austin, Texas, United States (enrolling)
• Mary Crowley Cancer Research Centers — Dallas, Texas, United States (enrolling)
• UT MD Anderson Cancer Center - Houston — Houston, Texas, United States (enrolling)
• NEXT Huston — Houston, Texas, United States (enrolling)
• NEXT Oncology — San Antonio, Texas, United States (enrolling)
• NEXT Virginia — Fairfax, Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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