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RecruitingPhase 1NCT06720987
Official study title

A Study to Investigate the Safety and Efficacy of KQB365 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies

Study summary

The goal of this clinical trial is to learn if KQB365 works to treat advanced solid tumor cancer in adults. It will also learn about the safety of KQB365. The main questions it aims to answer are: * What is the safe dose of KQB365 by itself, in combination with cetuximab, or in combination with KQB198? * Does KQB365 alone, in combination with cetuximab, or in combination with KQB198 decrease the size of the tumor? * What happens to KQB365 in the body? Participants will: * Receive KQB365 infusion weekly alone, in combination with cetuximab, or in combination with oral KQB198. * Visit the clinic about 9 times in the first 6 weeks, and then once every week after that.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedKQB365 and Cetuximab

Plus 1 other study approaches.

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?11 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: KQB365; Drug: Cetuximab; Drug: KQB198
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
  • PART 1 (monotherapy and combo therapy with KQB198): Histologically confirmed diagnosis of a solid tumor malignancy with either a KRAS G12C or KRAS G12S mutation.
  • PART 1 (combo therapy with Cetuximab) \& PART 2: Histologically confirmed diagnosis of adenocarcinoma of the colon or rectum with either a KRAS G12C or KRAS G12S mutation.
  • PART 1 (monotherapy Non-Small Cell Lung Cancer Cohort): Histologically confirmed diagnosis of Non-Small Cell Lung Cancer 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
Reasons someone may not be able to joinExclusion criteria
  • Active primary central nervous system tumors
  • Cardiac abnormalities
  • Active interstitial lung disease
  • Unable to swallow or GI condition that prevents absorption for patients in KQB198 combination cohorts

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

  • Mayo Clinic, PhoenixPhoenix, Arizona
  • Sarah Cannon Cancer Institute at HealthONEDenver, Colorado
  • Mayo Clinic, JacksonvilleJacksonville, Florida
  • Dana Farber Cancer InstituteBoston, Massachusetts
  • START MidwestGrand Rapids, Michigan
  • Mayo Clinic, RochesterRochester, Minnesota
  • Cleveland Clinic, Taussig Cancer InstituteCleveland, Ohio
  • OU Health Stephenson Cancer CenterOklahoma City, Oklahoma
  • Sydney Kimmel Cancer CenterPhiladelphia, Pennsylvania
  • NEXT OncologySan Antonio, Texas
  • NEXT Virginia, LLCFairfax, Virginia

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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