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Recruiting NCT07207707

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

Phase I Interventional Solid Tumor Malignancies

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: KQB548.
Who it may be relevant to
Registry conditions: Solid Tumor Malignancies. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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?

Interventions

  • Drug KQB548
    Oral KQB548

Primary outcome measures

  • Safety,Tolerability, MTD/MAD and/or RDE in the Study Population [Time frame: Up to 30 months]
Secondary outcome measures (12)
  • Plasma Concentration-time curve (AUC) [Time frame: Up to 30 months]
  • Maximum plasma concentration (Cmax) [Time frame: Up to 30 months]
  • Time to maximum plasma concentration (tmax) [Time frame: Up to 30 months]
  • Overall Response Rate (ORR) [Time frame: Up to 30 months]
  • Duration of Response (DOR) [Time frame: Up to 30 months]
  • Time to Response (TTR) [Time frame: Up to 30 months]
  • Disease Control Rate (DCR) [Time frame: Up to 30 months]
  • Progression Free Survival (PFS) [Time frame: Up to 30 months]
  • Overall Survival (OS) [Time frame: Up to 30 months]
  • Peak Plasma Concentration (Cmax) in Fed and Fasted States for Food Effect [Time frame: Up to 30 months]
  • Concentration Time Curve (AUC) in Fed and Fasted States for Food Effect [Time frame: Up to 30 months]
  • Time to maximum plasma concentration (tmax) in Fed and Fasted States for Food Effect [Time frame: Up to 30 months]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 13 centers
  • University of California, San Diego — La Jolla
  • University of California, Los Angeles — Los Angeles
  • SCRI - Denver — Denver
  • University of Miami - Sylvester Comprehensive Cancer Center — Miami
  • START Midwest — Grand Rapids
  • The Christ Hospital — Cincinnati
  • NEXT Oncology - Austin — Austin
  • MD Anderson Cancer Center — Houston
  • … and 5 more centers

Identifiers

NCT: NCT07207707 · KQB548-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗