Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06994806

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

Led by Kumquat Biosciences Inc. · Updated on 2026-03-03

84

Participants Needed

15

Research Sites

153 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 15 locations

1

Mayo Clinic - Phoenix

Phoenix, Arizona, United States, 85054

Actively Recruiting

2

USC Norris Comprehensive Cancer Center

Los Angeles, California, United States, 90033

Actively Recruiting

3

Sarah Cannon Cancer Institute at HealthONE

Denver, Colorado, United States, 80218

Actively Recruiting

4

Yale Cancer Center- New Haven

New Haven, Connecticut, United States, 06520

Actively Recruiting

5

Mayo Clinic - Jacksonville

Jacksonville, Florida, United States, 32224

Actively Recruiting

6

Florida Cancer Specialists - Sarasota

Sarasota, Florida, United States, 34232

Actively Recruiting

7

University of Iowa

Iowa City, Iowa, United States, 52242

Actively Recruiting

8

Mayo Clinic - Rochester

Rochester, Minnesota, United States, 55905

Actively Recruiting

9

Cleveland Clinic

Cleveland, Ohio, United States, 44195

Actively Recruiting

10

NEXT Austin

Austin, Texas, United States, 78758

Actively Recruiting

11

Mary Crowley Cancer Research Centers

Dallas, Texas, United States, 75230

Actively Recruiting

12

UT MD Anderson Cancer Center - Houston

Houston, Texas, United States, 77030

Actively Recruiting

13

NEXT Huston

Houston, Texas, United States, 77054

Actively Recruiting

14

NEXT Oncology

San Antonio, Texas, United States, 78229

Actively Recruiting

15

NEXT Virginia

Fairfax, Virginia, United States, 22031

Actively Recruiting

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Research Team

K

Kumquat Clinical Development

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

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