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
1 other identifier
interventional
78
1 country
12
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?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2025
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 3, 2025
CompletedStudy Start
First participant enrolled
September 16, 2025
CompletedFirst Posted
Study publicly available on registry
October 6, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
March 13, 2026
March 1, 2026
12 months
September 3, 2025
March 11, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety,Tolerability, MTD/MAD and/or RDE in the Study Population
Safety characterized by type, incidence and severity of treatment emergent adverse events (TEAEs), SAEs, and DLTs
Up to 30 months
Secondary Outcomes (13)
Plasma Concentration-time curve (AUC)
Up to 30 months
Maximum plasma concentration (Cmax)
Up to 30 months
Time to maximum plasma concentration (tmax)
Up to 30 months
Overall Response Rate (ORR)
Up to 30 months
Duration of Response (DOR)
Up to 30 months
- +8 more secondary outcomes
Study Arms (1)
Monotherapy Dose Escalation
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
University of California, San Diego
La Jolla, California, 92037, United States
University of California, Los Angeles
Los Angeles, California, 90095, United States
SCRI - Denver
Denver, Colorado, 80218, United States
University of Miami - Sylvester Comprehensive Cancer Center
Miami, Florida, 33136, United States
START Midwest
Grand Rapids, Michigan, 49546, United States
The Christ Hospital
Cincinnati, Ohio, 45219, United States
NEXT Oncology - Austin
Austin, Texas, 78758, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
NEXT Oncology - Dallas
Irving, Texas, 75039, United States
NEXT Oncology - San Antonio
San Antonio, Texas, 78229, United States
University of Utah - Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
NEXT Virginia
Fairfax, Virginia, 22031, United States
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 3, 2025
First Posted
October 6, 2025
Study Start
September 16, 2025
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
March 1, 2027
Last Updated
March 13, 2026
Record last verified: 2026-03