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NCT07542704RecruitingPhase 1

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

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

Source: ClinicalTrials.gov · Last updated 3 Nov 2026

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
48 (estimated)
First submitted
13 Apr 2026
Start date
27 May 2026
Primary completion date
Dec 2029
Lead sponsor
Kumquat Biosciences Inc.
NCT number
NCT07542704

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 48
  • From 27 May 2026 to the primary completion date, Dec 2029
  • 14 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Criteria the registry did not label

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (14)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
NEXT Oncology - Austin
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AustinUnited StatesRecruiting
Massachusetts General Hospital
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BostonUnited StatesRecruiting
UH Cleveland Medical Center
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ClevelandUnited StatesRecruiting
START Dallas- Fort Worth
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DallasUnited StatesRecruiting
Karmanos Cancer Institute
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DetroitUnited StatesRecruiting
NEXT Oncology- Virginia
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FairfaxUnited StatesRecruiting
John Theurer Cancer Center At Hackensack UMC
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HackensackUnited StatesRecruiting
START - Los Angeles
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Los AngelesUnited StatesRecruiting
SCRI Oncology Partners
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NashvilleUnited StatesRecruiting
Memorial Sloan-Kettering Cancer Center
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New YorkUnited StatesRecruiting
Fox Chase Cancer Center
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PhiladelphiaUnited StatesRecruiting
Providence Cancer Institute
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PortlandUnited StatesRecruiting
University of Utah - Huntsman Cancer Institute
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Salt Lake CityUnited StatesRecruiting
START | San Antonio
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San AntonioUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.