Recruiting
Phase 1

KQB548

Sponsor:

Kumquat Biosciences Inc.

Code:

NCT07207707

Conditions

Solid Tumor Malignancies

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

KQB548

Study Details

Brief 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?

Conditions

Solid Tumor Malignancies

Study ID

NCT07207707

Start date

Sep 16, 2025

Status verified date

Mar, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

78 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Monotherapy Dose Escalation

Interventions

KQB548

Oral KQB548

Primary outcome measure

  • Safety,Tolerability, MTD/MAD and/or RDE in the Study Population [ Time Frame: Up to 30 months ]

Central Contacts and Locations

Central contacts

Kumquat Clinical Development

858-214-2700kumquatstudies@kumquatbio.com

Locations

University of California, San Diego

Recruiting

La Jolla, California, United States, 92037

University of California, Los Angeles

Recruiting

Los Angeles, California, United States, 90095

SCRI - Denver

Recruiting

Denver, Colorado, United States, 80218

University of Miami - Sylvester Comprehensive Cancer Center

Recruiting

Miami, Florida, United States, 33136

START Midwest

Recruiting

Grand Rapids, Michigan, United States, 49546

The Christ Hospital

Recruiting

Cincinnati, Ohio, United States, 45219

NEXT Oncology - Austin

Recruiting

Austin, Texas, United States, 78758

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

NEXT Oncology - Dallas

Recruiting

Irving, Texas, United States, 75039

NEXT Oncology - San Antonio

Recruiting

San Antonio, Texas, United States, 78229

University of Utah - Huntsman Cancer Institute

Recruiting

Salt Lake City, Utah, United States, 84112

NEXT Virginia

Recruiting

Fairfax, Virginia, United States, 22031

Fred Hutchison Cancer Center

Recruiting

Seattle, Washington, United States, 98195

More Information

Sponsor

Kumquat Biosciences Inc.

Last update posted

May 20, 2026

Last verified

Mar, 2026

Keywords

  • KRAS
  • G12D

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Kumquat Biosciences Inc. on 2026-05-20.