Recruiting
Phase 1

KQB168 & Pembrolizumab

Sponsor:

Kumquat Biosciences Inc.

Code:

NCT06994806

Conditions

Solid Tumor Malignancies

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

KQB168

Pembrolizumab

Study Details

Brief summary:

The goal of this clinical trial is to learn if KQB168 works to treat advanced solid tumor cancer in adults. It will also learn about the safety of KQB168. The main questions it aims to answer are:

  • What is the safe dose of KQB168 by itself or in combination with pembrolizumab?
  • Does KQB168 alone or in combination with pembrolizumab decrease the size of the tumor?
  • What happens to KQB168 in the body?

Participants will:

  • Take KQB168 daily, alone or in combination with pembrolizumab
  • Visit the clinic about 8 times in the first 8 weeks, and then once every 3 weeks after that

Conditions

Solid Tumor Malignancies

Study ID

NCT06994806

Start date

Jun 24, 2025

Status verified date

Feb, 2026

Completion date

May 31, 2028

Anticipated

Primary completion date

Nov 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Histologically confirmed diagnosis of solid tumor malignancy.
  • Unresectable or metastatic disease that has progressed on immunotherapy.
  • No available treatment with curative intent
  • Adequate organ function
  • Measurable disease per RECIST v1.1

Exclusion Criteria:

  • Active primary central nervous system tumors
  • Cardiac abnormalities
  • History of lung diseases
  • Any condition that may impair drug absorption or prevent oral dosing
  • Known history of immune-mediated colitis and uncontrolled autoimmune diseases

Study Design

Enrollment

84 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Monotherapy Dose Escalation

Drug: KQB168 - Oral KQB168

experimental: Combo Therapy Dose Escalation

Drug: KQB168 - Oral KQB168 Drug: pembrolizumab - Intravenous pembrolizumab

Interventions

KQB168

Oral KQB168

Pembrolizumab

Intravenous pembrolizumab

Primary outcome measure

  • Number of patients who experience treatment-emergent adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs) [ Time Frame: up to 36 months ]

Central Contacts and Locations

Central contacts

Kumquat Clinical Development

(858) 214-2700kumquatstudies@kumquatbio.com

Locations

Mayo Clinic - Phoenix

Recruiting

Phoenix, Arizona, United States, 85054

Contacts

Robby Bennett

480-342-6641bennettiii.robert@mayo.edu

USC Norris Comprehensive Cancer Center

Recruiting

Los Angeles, California, United States, 90033

Contacts

Stephanie Kim

323-865-0240Stephanie.Kim2@med.usc.edu

Sarah Cannon Cancer Institute at HealthONE

Recruiting

Denver, Colorado, United States, 80218

Contacts

Brandon Johnson

720-754-2610brandon.johnson2@sarahcannon.com

Yale Cancer Center- New Haven

Recruiting

New Haven, Connecticut, United States, 06520

Contacts

Priscilla Steve

203-464-5564Priscilla.steve@yale.edu

Mayo Clinic - Jacksonville

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Kendal Klein

904-953-3545Klein.Kendal@mayo.edu

Florida Cancer Specialists - Sarasota

Recruiting

Sarasota, Florida, United States, 34232

Contacts

Sarah Gwirtz

941-377-9993sarah.gwirtz@flcancer.com

University of Iowa

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Jennifer Adams

319-467-6774jennifer-adams@uiowa.edu

Mayo Clinic - Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Siobhan Chantigian

507-738-7036chantigian.siobhan@mayo.edu

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Heather Keaney

216-444-3409keaneyh@ccf.org

NEXT Austin

Recruiting

Austin, Texas, United States, 78758

Contacts

Heather Watson

737-610-5202hwatson@nextoncology.com

Mary Crowley Cancer Research Centers

Recruiting

Dallas, Texas, United States, 75230

Contacts

Sangavi Manalan

972-566-3014sangavi.sethumanalan@scri.com

UT MD Anderson Cancer Center - Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Anupama Madhyannapu

346-722-9365admadhyannapu@mdanderson.org

NEXT Huston

Recruiting

Houston, Texas, United States, 77054

Contacts

Emma Morales

(832) 384-7912emorales@nextoncology.com

NEXT Oncology

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Jordan Georg

(210) 580-9521jgeorg@nextoncology.com

NEXT Virginia

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Referral Coordinator

(703) 783-4518mdelarosa@nextoncology.com

More Information

Sponsor

Kumquat Biosciences Inc.

Last update posted

Mar 3, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-11. This information was provided to ClinicalTrials.gov by Kumquat Biosciences Inc. on 2026-03-03.