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RECRUITING
NCT07542704
PHASE1

A Study to Investigate the Safety and Efficacy of KQB368 as Monotherapy in Participants With Advanced Solid Malignancies

Sponsor: Kumquat Biosciences Inc.

View on ClinicalTrials.gov

Summary

The goal of this study is to learn if KQB368 works to treat advanced solid malignancies in adults. The study will also learn about the safety of KQB368. The main questions the study aims to answer are: * What is the safe dose of KQB368 as a monotherapy? * Does KQB368 decrease the size of the tumor? * What happens to KQB368 in the body? Participants will: * Take KQB368 orally daily in 21-day cycles * Return to the study site about 7 times in the first 5 weeks, and then once at the beginning of every 21-day cycle after that

Official title: A Phase 1/1b, Open-label, Multicenter, Dose Escalation and Dose Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of KQB368 in Participants With Advanced Solid Malignancies With KRAS G12S or G12C Mutations

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

48

Start Date

2026-05-27

Completion Date

2029-12

Last Updated

2026-11-03

Healthy Volunteers

No

Interventions

DRUG

KQB368

Oral KQB368

Locations (14)

START Los Angeles

Los Angeles, California, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

John Theurer Cancer Center at Hackensack UMC

Hackensack, New Jersey, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

UH Cleveland Medical Center

Cleveland, Ohio, United States

Providence Cancer Institute

Portland, Oregon, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

NEXT Oncology Austin

Austin, Texas, United States

START Dallas Fort Worth

Dallas, Texas, United States

START San Antonio

San Antonio, Texas, United States

University of Utah - Huntsman Cancer Institute

Salt Lake City, Utah, United States

NEXT Oncology Virginia

Fairfax, Virginia, United States