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Study of KQB168 for Advanced Solid Tumor Cancers

This study is testing a new drug called KQB168, alone or with pembrolizumab (an immunotherapy drug), for adults with advanced solid tumor cancers. These are cancers that have spread or cannot be removed by surgery, and have gotten worse after previous immunotherapy treatment. The main goals are to find a safe dose of KQB168, see if it can shrink tumors, and understand how the body uses the drug. You may be able to join if you have a solid tumor that has progressed on immunotherapy, no other curative treatment options, and meet other health requirements. The study is currently unclear on its recruitment status and plans to enroll 84 participants.

Study design
This is an interventional study with an unspecified phase, planning to enroll 84 participants. It will investigate KQB168 as a monotherapy and in combination with pembrolizumab.
What's involved
Participants will take KQB168 daily, alone or with pembrolizumab. You will visit the clinic about 8 times in the first 8 weeks, and then once every 3 weeks after that.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for treatment-emergent adverse events (side effects), serious adverse events, and dose-limiting toxicities for up to 36 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06994806

A Study to Investigate the Safety and Efficacy of KQB168 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies

Recruiting
PHASE1Ages 18+InterventionalTreatment
Kumquat Biosciences Inc.
~84 participants
Updated 2026-03-03 on ClinicalTrials.gov
What's tested:KQB168Pembrolizumab

At a glance

Recruiting sites
15 of 15 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of patients who experience treatment-emergent adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs)
Measured over up to 36 months

Conditions

Solid Tumor Malignancies

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NCT06994806

Where you'd take part

This study runs at 15 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Cleveland Clinic

    Cleveland, Ohiostudy coordinator listed

    Recruiting

  • Florida Cancer Specialists - Sarasota

    Sarasota, Floridastudy coordinator listed

    Recruiting

  • Mary Crowley Cancer Research Centers

    Dallas, Texasstudy coordinator listed

    Recruiting

  • Mayo Clinic - Jacksonville

    Jacksonville, Floridastudy coordinator listed

    Recruiting

  • Mayo Clinic - Phoenix

    Phoenix, Arizonastudy coordinator listed

    Recruiting

  • Mayo Clinic - Rochester

    Rochester, Minnesotastudy coordinator listed

    Recruiting

  • NEXT Austin

    Austin, Texasstudy coordinator listed

    Recruiting

  • NEXT Huston

    Houston, Texasstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Kumquat Clinical Development
[email protected]
(858) 214-2700
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

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

    Safety characterized by type, incidence, severity, timing, seriousness and relationship to study treatment of AEs, SAEs, and DLTs, from first dose of study treatment to 30 days after last dose of study treatment.