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NCT06720987PHASE1Recruiting

A Study to Investigate the Safety and Efficacy of KQB365 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies

Kumquat Biosciences Inc.

Start Date

2/4/2025

Completion Date

6/30/2030

Summary

The goal of this clinical trial is to learn if KQB365 works to treat advanced solid tumor cancer in adults. It will also learn about the safety of KQB365. The main questions it aims to answer are: * What is the safe dose of KQB365 by itself, in combination with cetuximab, or in combination with KQB198? * Does KQB365 alone, in combination with cetuximab, or in combination with KQB198 decrease the size of the tumor? * What happens to KQB365 in the body? Participants will: * Receive KQB365 infusion weekly alone, in combination with cetuximab, or in combination with oral KQB198. * Visit the clinic about 9 times in the first 6 weeks, and then once every week after that.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * PART 1 (monotherapy and combo therapy with KQB198): Histologically confirmed diagnosis of a solid tumor malignancy with either a KRAS G12C or KRAS G12S mutation. * PART 1 (combo therapy with Cetuximab) \& PART 2: Histologically confirmed diagnosis of adenocarcinoma of the colon or rectum with either a KRAS G12C or KRAS G12S mutation. * Unresectable or metastatic disease * 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 * Active interstitial lung disease * Unable to swallow or GI condition that prevents absorption for patients in KQB198 combination cohorts

Interventions

DRUG

KQB365

DRUG

Cetuximab

DRUG

KQB198

Interested in This Trial?

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Conditions

KRAS G12C MutationKRAS G12S MutationSolid Tumor MalignanciesCRC (Colorectal Cancer)

Locations

Mayo Clinic, Phoenix

Phoenix, Arizona 85054

United States

Sarah Cannon Cancer Institute at HealthONE

Denver, Colorado 80218

United States

Mayo Clinic, Jacksonville

Jacksonville, Florida 32224

United States

Dana Farber Cancer Institute

Boston, Massachusetts 02215

United States

START Midwest

Grand Rapids, Michigan 49546

United States

Mayo Clinic, Rochester

Rochester, Minnesota 55905

United States

Cleveland Clinic, Taussig Cancer Institute

Cleveland, Ohio 44195

United States

OU Health Stephenson Cancer Center

Oklahoma City, Oklahoma 73104

United States

Sydney Kimmel Cancer Center

Philadelphia, Pennsylvania 19107

United States

NEXT Oncology

San Antonio, Texas 78229

United States

NEXT Virginia, LLC

Fairfax, Virginia 22031

United States