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RECRUITING
NCT06994806
PHASE1

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.

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

84

Start Date

2025-06-24

Completion Date

2028-05-31

Last Updated

2026-03-03

Healthy Volunteers

No

Interventions

DRUG

KQB168

Oral KQB168

DRUG

Pembrolizumab

Intravenous pembrolizumab

Locations (15)

Mayo Clinic - Phoenix

Phoenix, Arizona, United States

USC Norris Comprehensive Cancer Center

Los Angeles, California, United States

Sarah Cannon Cancer Institute at HealthONE

Denver, Colorado, United States

Yale Cancer Center- New Haven

New Haven, Connecticut, United States

Mayo Clinic - Jacksonville

Jacksonville, Florida, United States

Florida Cancer Specialists - Sarasota

Sarasota, Florida, United States

University of Iowa

Iowa City, Iowa, United States

Mayo Clinic - Rochester

Rochester, Minnesota, United States

Cleveland Clinic

Cleveland, Ohio, United States

NEXT Austin

Austin, Texas, United States

Mary Crowley Cancer Research Centers

Dallas, Texas, United States

UT MD Anderson Cancer Center - Houston

Houston, Texas, United States

NEXT Huston

Houston, Texas, United States

NEXT Oncology

San Antonio, Texas, United States

NEXT Virginia

Fairfax, Virginia, United States