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NCT Number: NCT07542704

A Study to Investigate the Safety and Efficacy of KQB368 as Monotherapy in Participants With Advanced Solid Malignancies

The goal of this study is to learn if KQB368 works to treat advanced solid malignancies in adults. The study will also learn about the safety of KQB368. The main questions the study aims to answer are:

* What is the safe dose of KQB368 as a monotherapy? * Does KQB368 decrease the size of the tumor? * What happens to KQB368 in the body?

Participants will:

* Take KQB368 orally daily in 21-day cycles * Return to the study site about 7 times in the first 5 weeks, and then once at the beginning of every 21-day cycle after that

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Key information

Conditions

Advanced Solid Tumors Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Colonic Diseases Colorectal Cancer (CRC) Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Intestinal Diseases Intestinal Neoplasms KRAS G12C Mutations KRAS G12S Mutations Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Non-small Cell Lung Cancer Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms Uterine Cancer Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

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

  • Histologically confirmed diagnosis of a solid tumor
  • Malignancy with either a KRAS G12C or KRAS G12S mutation
  • Unresectable or metastatic disease
  • No available treatment with curative intent
  • Adequate organ function
  • Measurable disease per RECIST v1.1
  • Must be able to swallow with no GI condition that prevents absorption

Treatment and study plan

KQB368

Drug

Oral KQB368

Primary outcomes

  1. Primary Objective

    Time frame: Up to 44 months

    Number of patients who experience treatment-emergent adverse events, serious adverse events, and dose-limiting toxicities.

    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. Objective response rate (ORR)

    Time frame: Up to 44 months

    Evaluate efficacy of study treatment, as measured by Objective Response Rate (ORR) using Response Evaluation Criteria (RECISTv1.1). Objective response is the proportion of subjects that experience confirmed complete response (CR) or partial response (PR) based on RECIST v1.1 during the time period from first dose of study treatment until last dose.

  2. Overall survival (OS)

    Time frame: Up to 44 months

    Evaluate efficacy of study treatment characterized by OS. Overall survival is defined as the time from start of treatment to death.

  3. Duration of response (DOR)

    Time frame: Up to 44 months

    Duration of response is defined as the time from date of the first documentation of objective tumor response (CR or PR) based on RECIST v1.1 to the first documentation of either PD or death due to any cause, whichever occurs first.

  4. Time to response (TTR)

    Time frame: Up to 44 months

    Time to response is defined as time from first dose of study treatment to date of first documentation of objective tumor response (CR or PR) based on RECIST v1.1.

  5. Disease control rate (DCR)

    Time frame: Up to 44 months

    Disease control rate is the proportion of subjects that experience confirmed complete response (CR), partial response (PR), or stable disease based on RECIST v1.1 during the time period from first dose of study treatment until last dose.

  6. Progression-free survival (PFS)

    Time frame: Up to 44 months

    Progression-free survival is defined as the time from enrollment to the date of Progressive Disease (PD) based on RECIST v1.1 or death due to any cause, whichever occurs first.

  7. Area under the concentration-time curve (AUC)

    Time frame: Up to 44 months

  8. Maximum plasma concentration (Cmax)

    Time frame: Up to 44 months

  9. Time to maximum plasma concentration (tmax)

    Time frame: Up to 44 months

Study contacts

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

Kumquat Clinical Development Telephone

CONTACT

[email protected]

858.214.2700

Sponsors and collaborators

Lead sponsor

Kumquat Biosciences Inc.

Industry

Collaborators

  • Worldwide Clinical Trials

Registry information

Official study title

A Phase 1/1b, Open-label, Multicenter, Dose Escalation and Dose Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of KQB368 in Participants With Advanced Solid Malignancies With KRAS G12S or G12C Mutations

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Apr 21, 2026
Registry last updated
Apr 21, 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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