Recruiting
Phase 1

KQB368

Sponsor:

Kumquat Biosciences Inc.

Code:

NCT07542704

Conditions

Advanced Solid Tumors

Colorectal Cancer (CRC)

Non-Small Cell Lung Cancer

Uterine Cancer

KRAS G12C Mutations

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

KQB368

Study Details

Brief 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

Conditions

Advanced Solid Tumors

Colorectal Cancer (CRC)

Non-Small Cell Lung Cancer

Uterine Cancer

KRAS G12C Mutations

Study ID

NCT07542704

Start date

May 27, 2026

Status verified date

Oct, 2026

Completion date

Dec, 2029

Anticipated

Primary completion date

Dec, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

  • 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

Study Design

Enrollment

48 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Monotherapy Dose Escalation

Interventions

KQB368

Oral KQB368

Primary outcome measure

  • Primary Objective [ Time Frame: Up to 44 months ]

Central Contacts and Locations

Central contacts

Kumquat Clinical Development Telephone

858.214.2700kumquatstudies@kumquatbio.com

Locations

START Los Angeles

Recruiting

Los Angeles, California, United States, 90025

Contacts

Navid Hafez

858-214-2700kumquatstudies@kumquatbio.com

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Leon Pappas

858-214-2700kumquatstudies@kumquatbio.com

Karmanos Cancer Institute

Recruiting

Detroit, Michigan, United States, 48201

Contacts

Wasif Saif

kumquatstudies@kumquatbio.com

John Theurer Cancer Center at Hackensack UMC

Recruiting

Hackensack, New Jersey, United States, 07601

Contacts

Miguel Gonzalez

858-214-2700kumquatstudies@kumquatbio.com

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Rona Yaeger

8582142729kumquatstudies@kumquatbio.com

UH Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Matthew Mirsky

8582142729kumquatstudies@kumquatbio.com

Providence Cancer Institute

Recruiting

Portland, Oregon, United States, 97213

Contacts

Rachel Sanborn

858-214-2700kumquatstudies@kumquatbio.com

Fox Chase Cancer Center

Recruiting

Philadelphia, Pennsylvania, United States, 19111

Contacts

Anthony Olszanski

858-214-2700kumquatstudies@kumquatbio.com

SCRI Oncology Partners

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Deepak Bhamidipati

8582142729kumquatstudies@kumquatbio.com

NEXT Oncology Austin

Recruiting

Austin, Texas, United States, 78758

Contacts

Sheena Sahota MD

858-214-2700kumquatstudies@kumquatbio.com

START Dallas Fort Worth

Recruiting

Dallas, Texas, United States, 76104

Contacts

Henry Xiong

858-214-2700kumquatstudies@kumquatbio.com

START San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Drew Rasco

kumquatstudies@kumquatbio.com

University of Utah - Huntsman Cancer Institute

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Theresa Werner

858-214-2700kumquatstudies@kumquatbio.com

NEXT Oncology Virginia

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Alexander Spira MD

858-214-2700kumquatstudies@kumquatbio.com

More Information

Sponsor

Kumquat Biosciences Inc.

Last update posted

Nov 3, 2026

Last verified

Oct, 2026

Keywords

  • KQB368

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-04. This information was provided to ClinicalTrials.gov by Kumquat Biosciences Inc. on 2026-11-03. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.