RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

A Phase 1, Open-label, Multicenter, Dose Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of KQB168 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Malignancies

Quick Facts

Study Start:2025-06-24
Study Completion:2028-05-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06994806

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Histologically confirmed diagnosis of solid tumor malignancy.
  2. * Unresectable or metastatic disease that has progressed on immunotherapy.
  3. * No available treatment with curative intent
  4. * Adequate organ function
  5. * Measurable disease per RECIST v1.1
  1. * Active primary central nervous system tumors
  2. * Cardiac abnormalities
  3. * History of lung diseases
  4. * Any condition that may impair drug absorption or prevent oral dosing
  5. * Known history of immune-mediated colitis and uncontrolled autoimmune diseases

Contacts and Locations

Study Contact

Kumquat Clinical Development
CONTACT
(858) 214-2700
kumquatstudies@kumquatbio.com

Study Locations (Sites)

NEXT Austin
Austin, Texas, 78758
United States
NEXT Huston
Houston, Texas, 77054
United States
NEXT Oncology
San Antonio, Texas, 78229
United States
NEXT Virginia
Fairfax, Virginia, 22031
United States

Collaborators and Investigators

Sponsor: Kumquat Biosciences Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-24
Study Completion Date2028-05-31

Study Record Updates

Study Start Date2025-06-24
Study Completion Date2028-05-31

Terms related to this study

Additional Relevant MeSH Terms

  • Solid Tumor Malignancies