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

A Phase 1a, Open-label, Multicenter, Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of KQB548 in Participants With Advanced Solid Malignancies With a KRAS G12D Mutation

Who can join

Ages 18 and older · All sexes

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

About the study

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?

What is being tested

• KQB548 (drug)

Sponsor: Kumquat Biosciences Inc. · Participants: 78 · Started: Sep 16, 2025

Contact the study team

• Kumquat Clinical Development · Phone: 858-214-2700

Official record on ClinicalTrials.gov — NCT07207707

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.