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NCT07207707PHASE1Recruiting

A Study to Investigate the Safety and Efficacy of KQB548 in Participants With Advanced Solid Malignancies

Kumquat Biosciences Inc.

Start Date

9/16/2025

Completion Date

3/1/2027

Summary

The goal of this trial is to learn if KQB548 works to treat patients with advanced solid malignancies with a KRAS G12D mutation. It will also learn about the safety of KQB548. The main questions it aims to answer are: * What is the safe dose of KQB548? * Does KQB548 decrease the size of the tumor? * What happens to KQB548 in the body?

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Pathologically confirmed, locally advanced or metastatic PDAC, CRC, or NSCLC with a KRAS G12D mutation * Progressed on, or intolerant to at least one prior line of systemic standard of care therapy * Measurable disease according to RECIST v1.1 * Adequate organ function Exclusion Criteria: * Previous treatment with a KRAS G12D inhibitor or pan-RAS inhibitor * History of intestinal disease, uncontrolled inflammatory bowel disease (e.g., Crohn's disease, Ulcerative Colitis), major esophageal or gastric surgery, or other gastrointestinal conditions (e.g., uncontrolled nausea, vomiting, malabsorption syndrome) likely to alter absorption of study intervention or result in inability to swallow oral medications * Poorly controlled ascites and/or pleural effusion * Requires treatment with a strong and/or moderate CYP3A inhibitor or inducer * Requires treatment with a proton-pump inhibitor

Interventions

DRUG

KQB548

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Conditions

Solid Tumor Malignancies

Locations

University of California, San Diego

La Jolla, California 92037

United States

University of California, Los Angeles

Los Angeles, California 90095

United States

SCRI - Denver

Denver, Colorado 80218

United States

University of Miami - Sylvester Comprehensive Cancer Center

Miami, Florida 33136

United States

START Midwest

Grand Rapids, Michigan 49546

United States

The Christ Hospital

Cincinnati, Ohio 45219

United States

NEXT Oncology - Austin

Austin, Texas 78758

United States

MD Anderson Cancer Center

Houston, Texas 77030

United States

NEXT Oncology - Dallas

Irving, Texas 75039

United States

NEXT Oncology - San Antonio

San Antonio, Texas 78229

United States

University of Utah - Huntsman Cancer Institute

Salt Lake City, Utah 84112

United States

NEXT Virginia

Fairfax, Virginia 22031

United States

Fred Hutchison Cancer Center

Seattle, Washington 98195

United States