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Clinical Trials in the USA / NCT06994806
Recruiting Phase 1

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

NCT06994806 · tracked via the Priya Life Science USA tracker
Sponsor
Kumquat Biosciences Inc
Phase
Phase 1
Started
2025-06-24
Last updated
2026-03-03

Condition(s) studied

Solid Tumor Malignancies

Investigational drug(s) / intervention(s)

KQB168Pembrolizumab →

KQB168: Oral KQB168

Pembrolizumab: Intravenous pembrolizumab

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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.

Trial sites (15)

FacilityCityRegionStatus
Mayo Clinic - Phoenix Phoenix Arizona Recruiting
USC Norris Comprehensive Cancer Center Los Angeles California Recruiting
Sarah Cannon Cancer Institute at HealthONE Denver Colorado Recruiting
Yale Cancer Center- New Haven New Haven Connecticut Recruiting
Mayo Clinic - Jacksonville Jacksonville Florida Recruiting
Florida Cancer Specialists - Sarasota Sarasota Florida Recruiting
University of Iowa Iowa City Iowa Recruiting
Mayo Clinic - Rochester Rochester Minnesota Recruiting
Cleveland Clinic Cleveland Ohio Recruiting
NEXT Austin Austin Texas Recruiting
Mary Crowley Cancer Research Centers Dallas Texas Recruiting
UT MD Anderson Cancer Center - Houston Houston Texas Recruiting
NEXT Huston Houston Texas Recruiting
NEXT Oncology San Antonio Texas Recruiting
NEXT Virginia Fairfax Virginia Recruiting

On this site

📄 Keytruda (pembrolizumab) drug profile →

More Kumquat Biosciences Inc. trials in the USA

A Study to Investigate the Safety and Efficacy of KQB198 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies Active, not recruiting
A Study to Investigate the Safety and Efficacy of KQB548 in Participants With Advanced Solid Malignancies Recruiting
KQB198 in Combination With Imatinib in Participants With Advanced/Metastatic GIST in 1st Line Setting (SynerGIST-1st Line) Recruiting
A Study to Investigate the Safety and Efficacy of KQB365 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies Recruiting
A Study to Investigate the Safety and Efficacy of KQB198 as Monotherapy and in Combination in Participants With Advanced Hematologic Malignancies Active, not recruiting

Other trials for the same condition

A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of TJ101 in Patients With Advanced/Metastatic Solid Tumors Recruiting
A First-In-Human, Phase 1 Study Evaluating Oral TACC3 PPI Inhibitor, AO-252, in Advanced Solid Tumors With or Without Brain Metastases Recruiting
Olutasidenib DDI Study in Patients With IDH1 Mutation Positive Malignancies Recruiting
Safety and Preliminary Efficacy of VIR-5525 and VIR-5525 + Pembrolizumab in Participants With Locally Advanced or Metastatic Solid Tumors Recruiting
Study of CP-383 in Patients With Advanced or Metastatic Solid Tumors Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06994806 on ClinicalTrials.gov ↗ ← All trials in the USA