Back to Trials
NCT06994806PHASE1Recruiting

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

Kumquat Biosciences Inc.

Start Date

6/24/2025

Completion Date

5/31/2028

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 Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

KQB168

DRUG

Pembrolizumab

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Solid Tumor Malignancies

Locations

Mayo Clinic - Phoenix

Phoenix, Arizona 85054

United States

USC Norris Comprehensive Cancer Center

Los Angeles, California 90033

United States

Sarah Cannon Cancer Institute at HealthONE

Denver, Colorado 80218

United States

Yale Cancer Center- New Haven

New Haven, Connecticut 06520

United States

Mayo Clinic - Jacksonville

Jacksonville, Florida 32224

United States

Florida Cancer Specialists - Sarasota

Sarasota, Florida 34232

United States

University of Iowa

Iowa City, Iowa 52242

United States

Mayo Clinic - Rochester

Rochester, Minnesota 55905

United States

Cleveland Clinic

Cleveland, Ohio 44195

United States

NEXT Austin

Austin, Texas 78758

United States

Mary Crowley Cancer Research Centers

Dallas, Texas 75230

United States

UT MD Anderson Cancer Center - Houston

Houston, Texas 77030

United States

NEXT Huston

Houston, Texas 77054

United States

NEXT Oncology

San Antonio, Texas 78229

United States

NEXT Virginia

Fairfax, Virginia 22031

United States