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NCT Number: NCT07207707

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

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?

Recruiting

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Key information

Conditions

Solid Tumor Malignancies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of California, San Diego, La Jolla, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

KQB548

Drug

Oral KQB548

Primary outcomes

  1. Safety,Tolerability, MTD/MAD and/or RDE in the Study Population

    Time frame: Up to 30 months

    Safety characterized by type, incidence and severity of treatment emergent adverse events (TEAEs), SAEs, and DLTs

Secondary outcomes

  1. Plasma Concentration-time curve (AUC)

    Time frame: Up to 30 months

  2. Maximum plasma concentration (Cmax)

    Time frame: Up to 30 months

  3. Time to maximum plasma concentration (tmax)

    Time frame: Up to 30 months

  4. Overall Response Rate (ORR)

    Time frame: Up to 30 months

    Per RECIST v1.1

  5. Duration of Response (DOR)

    Time frame: Up to 30 months

    Per RECIST v1.1

  6. Time to Response (TTR)

    Time frame: Up to 30 months

    Per RECIST v1.1

  7. Disease Control Rate (DCR)

    Time frame: Up to 30 months

    Per RECIST v1.1

  8. Progression Free Survival (PFS)

    Time frame: Up to 30 months

    Per RECIST 1.1

  9. Overall Survival (OS)

    Time frame: Up to 30 months

    Per RECIST v1.1

  10. Peak Plasma Concentration (Cmax) in Fed and Fasted States for Food Effect

    Time frame: Up to 30 months

  11. Concentration Time Curve (AUC) in Fed and Fasted States for Food Effect

    Time frame: Up to 30 months

  12. Time to maximum plasma concentration (tmax) in Fed and Fasted States for Food Effect

    Time frame: Up to 30 months

  13. Evaluate Changes in QTc (mSec)

    Time frame: Up to 30 months

Study contacts

Contact information is provided by the study sponsor or research team.

Kumquat Clinical Development

CONTACT

[email protected]

858-214-2700

Sponsors and collaborators

Lead sponsor

Kumquat Biosciences Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Oct 6, 2025
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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