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NCT Number: NCT06994806

A Study to Investigate the Safety and Efficacy of KQB168 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies

The goal of this clinical trial is to learn if KQB168 works to treat advanced solid tumor cancer in adults. It will also learn about the safety of KQB168. The main questions it aims to answer are:

* What is the safe dose of KQB168 by itself or in combination with pembrolizumab? * Does KQB168 alone or in combination with pembrolizumab decrease the size of the tumor? * What happens to KQB168 in the body?

Participants will:

* Take KQB168 daily, alone or in combination with pembrolizumab * Visit the clinic about 8 times in the first 8 weeks, and then once every 3 weeks after that

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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

Mayo Clinic - Phoenix, Phoenix, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Histologically confirmed diagnosis of solid tumor malignancy.
  • Unresectable or metastatic disease that has progressed on immunotherapy.
  • No available treatment with curative intent
  • Adequate organ function
  • Measurable disease per RECIST v1.1

Exclusion criteria

  • Active primary central nervous system tumors
  • Cardiac abnormalities
  • History of lung diseases
  • Any condition that may impair drug absorption or prevent oral dosing
  • Known history of immune-mediated colitis and uncontrolled autoimmune diseases

Treatment and study plan

KQB168

Drug

Oral KQB168

Pembrolizumab

Drug

Intravenous pembrolizumab

Primary outcomes

  1. Number of patients who experience treatment-emergent adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs)

    Time frame: up to 36 months

    Safety characterized by type, incidence, severity, timing, seriousness and relationship to study treatment of AEs, SAEs, and DLTs, from first dose of study treatment to 30 days after last dose of study treatment.

Secondary outcomes

  1. Overall response rate (ORR)

    Time frame: up to 36 months

    Using RECIST v1.1

  2. Duration of response (DOR)

    Time frame: up to 36 months

    Using RECIST v1.1

  3. Time to response (TTR)

    Time frame: up to 36 months

    Using RECIST v1.1

  4. Disease control rate (DCR)

    Time frame: up to 36 months

    Using RECIST v1.1

  5. Progression-free survival (PFS)

    Time frame: up to 36 months

    Using RECIST v1.1

  6. Overall survival (OS)

    Time frame: up to 36 months

    using RECIST v1.1

  7. Concentration-time curve (AUC)

    Time frame: up to 36 months

  8. Maximum plasma concentration (Cmax)

    Time frame: up to 36 months

  9. Time to maximum plasma concentration (tmax)

    Time frame: up to 36 months

  10. Pharmacologically Active Dose (PAD)

    Time frame: up to 36 months

    Assessment of tumor and systemic immune activation

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 1, Open-label, Multicenter, Dose Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of KQB168 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Malignancies

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
May 29, 2025
Registry last updated
Mar 3, 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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