A Study to Investigate the Safety and Efficacy of KQB548 in Participants With Advanced Solid Malignancies
- Conditions
- Solid Tumor Malignancies
- Interventions
- Drug: KQB548
- Registration Number
- NCT07207707
- Lead Sponsor
- Kumquat Biosciences Inc.
- 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?
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 78
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Monotherapy Dose Escalation KQB548 -
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method Evaluate Changes in QTc (mSec) Up to 30 months 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 Per RECIST v1.1
Duration of Response (DOR) Up to 30 months Per RECIST v1.1
Time to Response (TTR) Up to 30 months Per RECIST v1.1
Disease Control Rate (DCR) Up to 30 months Per RECIST v1.1
Progression Free Survival (PFS) Up to 30 months Per RECIST 1.1
Overall Survival (OS) Up to 30 months Per RECIST v1.1
Peak Plasma Concentration (Cmax) in Fed and Fasted States for Food Effect Up to 30 months Concentration Time Curve (AUC) in Fed and Fasted States for Food Effect Up to 30 months Time to maximum plasma concentration (tmax) in Fed and Fasted States for Food Effect Up to 30 months
Trial Locations
- Locations (5)
START Midwest
🇺🇸Grand Rapids, Michigan, United States
NEXT Oncology - Austin
🇺🇸Austin, Texas, United States
NEXT Oncology - Dallas
🇺🇸Irving, Texas, United States
NEXT Oncology - San Antonio
🇺🇸San Antonio, Texas, United States
NEXT Virginia
🇺🇸Fairfax, Virginia, United States
START Midwest🇺🇸Grand Rapids, Michigan, United States