Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT07207707

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

Led by Kumquat Biosciences Inc. · Updated on 2026-03-13

78

Participants Needed

12

Research Sites

75 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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?

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Pathologically confirmed, locally advanced or metastatic pancreatic ductal adenocarcinoma, colorectal cancer, or non-small cell lung cancer 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
Not Eligible

You will not qualify if you...

  • Previous treatment with a KRAS G12D inhibitor or pan-RAS inhibitor
  • History of intestinal disease or uncontrolled inflammatory bowel disease such as Crohn's disease or Ulcerative Colitis
  • Major esophageal or gastric surgery or other gastrointestinal conditions likely to alter absorption or cause 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 12 locations

1

University of California, San Diego

La Jolla, California, United States, 92037

Actively Recruiting

2

University of California, Los Angeles

Los Angeles, California, United States, 90095

Actively Recruiting

3

SCRI - Denver

Denver, Colorado, United States, 80218

Actively Recruiting

4

University of Miami - Sylvester Comprehensive Cancer Center

Miami, Florida, United States, 33136

Actively Recruiting

5

START Midwest

Grand Rapids, Michigan, United States, 49546

Actively Recruiting

6

The Christ Hospital

Cincinnati, Ohio, United States, 45219

Actively Recruiting

7

NEXT Oncology - Austin

Austin, Texas, United States, 78758

Actively Recruiting

8

MD Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

9

NEXT Oncology - Dallas

Irving, Texas, United States, 75039

Actively Recruiting

10

NEXT Oncology - San Antonio

San Antonio, Texas, United States, 78229

Actively Recruiting

11

University of Utah - Huntsman Cancer Institute

Salt Lake City, Utah, United States, 84112

Actively Recruiting

12

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

NA

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

1

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