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Recruiting Phase 1

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

NCT07207707 · tracked via the Priya Life Science USA tracker
Phase
Phase 1
Started
2025-09-16
Last updated
2026-05-20

Condition(s) studied

Solid Tumor Malignancies

Investigational drug(s) / intervention(s)

KQB548

KQB548: Oral KQB548

Study 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?

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Safety,Tolerability, MTD/MAD and/or RDE in the Study Population — Up to 30 months
    Safety characterized by type, incidence and severity of treatment emergent adverse events (TEAEs), SAEs, and DLTs

Trial sites (13)

FacilityCityRegionStatus
University of California, San Diego La Jolla California Recruiting
University of California, Los Angeles Los Angeles California Recruiting
SCRI - Denver Denver Colorado Recruiting
University of Miami - Sylvester Comprehensive Cancer Center Miami Florida Recruiting
START Midwest Grand Rapids Michigan Recruiting
The Christ Hospital Cincinnati Ohio Recruiting
NEXT Oncology - Austin Austin Texas Recruiting
MD Anderson Cancer Center Houston Texas Recruiting
NEXT Oncology - Dallas Irving Texas Recruiting
NEXT Oncology - San Antonio San Antonio Texas Recruiting
University of Utah - Huntsman Cancer Institute Salt Lake City Utah Recruiting
NEXT Virginia Fairfax Virginia Recruiting
Fred Hutchison Cancer Center Seattle Washington Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07207707 on ClinicalTrials.gov ↗ ← All trials in the USA