KQB548 for advanced solid tumors with a KRAS G12D mutation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 1, open-label interventional study gives escalating doses of KQB548 to adults with advanced solid tumors harboring KRAS G12D to identify the safest dose and dosing schedule. Participants must have measurable disease by RECIST v1.1 and adequate organ function and will have imaging at regular intervals to look for tumor shrinkage. Blood and other samples will be collected to characterize how the drug is absorbed, distributed, metabolized, and excreted and to monitor safety and side effects. Key exclusions include prior KRAS G12D or pan‑RAS inhibitor therapy and gastrointestinal conditions or concomitant medications likely to alter oral drug absorption.

Why it matters

Who can join: the full rules

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

Where it's running

• University of California, San Diego
  La Jolla, California, United States Recruiting
• University of California, Los Angeles
  Los Angeles, California, United States Recruiting
• SCRI - Denver
  Denver, Colorado, United States Recruiting
• University of Miami - Sylvester Comprehensive Cancer Center
  Miami, Florida, United States Recruiting
• START Midwest
  Grand Rapids, Michigan, United States Recruiting
• The Christ Hospital
  Cincinnati, Ohio, United States Recruiting

Study contacts

• Study coordinator: Kumquat Clinical Development
• Email: kumquatstudies@kumquatbio.com
• Phone: 858-214-2700

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.