KQB548 for advanced solid tumors with a KRAS G12D mutation
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
This trial will test whether KQB548 can shrink tumors and is safe in adults with advanced pancreatic, colorectal, or non-small cell lung cancer that have a KRAS G12D mutation after prior therapy.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 78 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Kumquat Biosciences Inc. Industry-sponsored |
| Locations | 12 sites (La Jolla, California and 11 other locations) |
| Trial ID | NCT07207707 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults with pathologically confirmed, locally advanced or metastatic pancreatic ductal adenocarcinoma, colorectal cancer, or non-small cell lung cancer carrying a KRAS G12D mutation who have progressed on or are intolerant to at least one line of standard systemic therapy, have measurable disease, and adequate organ function.
Not a fit: Patients previously treated with a KRAS G12D or pan‑RAS inhibitor, those with gastrointestinal conditions that prevent oral medication absorption or swallowing, with uncontrolled ascites or pleural effusion, or who require strong/moderate CYP3A modulators or proton-pump inhibitors are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, KQB548 could offer a new targeted treatment option that shrinks tumors in patients with KRAS G12D-driven cancers.
How similar studies have performed: KRAS-targeted drugs have shown clinical success for the G12C mutation, but G12D-specific inhibitors are newer and currently have limited clinical data.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
La Jolla, California and 11 other locations
- 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)
- NEXT Oncology - Austin — Austin, Texas, United States (Recruiting)
- MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
- NEXT Oncology - Dallas — Irving, Texas, United States (Recruiting)
- NEXT Oncology - San Antonio — San Antonio, Texas, United States (Recruiting)
- University of Utah - Huntsman Cancer Institute — Salt Lake City, Utah, United States (Recruiting)
- NEXT Virginia — Fairfax, Virginia, United States (Recruiting)
Study contacts
- Study coordinator: Kumquat Clinical Development
- Email: kumquatstudies@kumquatbio.com
- Phone: 858-214-2700
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.