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RecruitingPhase 1NCT07542704
Official study title

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

Study summary

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 things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedKQB368

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · KRAS

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Nov 3, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Phase 1

Interventional

Where is it offered?14 U.S. locations

Locations may change over time.

Who runs it?Kumquat Biosciences Inc.

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Kumquat Biosciences Inc.
Interventions being studied
Drug: KQB368
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Biomarkers
KRAS→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • START Los AngelesLos Angeles, California
  • Massachusetts General HospitalBoston, Massachusetts
  • Karmanos Cancer InstituteDetroit, Michigan
  • John Theurer Cancer Center at Hackensack UMCHackensack, New Jersey
  • Memorial Sloan Kettering Cancer CenterNew York, New York
  • UH Cleveland Medical CenterCleveland, Ohio
  • Providence Cancer InstitutePortland, Oregon
  • Fox Chase Cancer CenterPhiladelphia, Pennsylvania
  • SCRI Oncology PartnersNashville, Tennessee
  • NEXT Oncology AustinAustin, Texas
  • START Dallas Fort WorthDallas, Texas
  • START San AntonioSan Antonio, Texas

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 3, 2026. Always confirm current availability with the study team.

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