KQB168 alone or with pembrolizumab for adults with advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1, dose-finding trial gives daily oral KQB168 either by itself or combined with pembrolizumab to adults with unresectable or metastatic solid tumors. The study escalates or adjusts doses to identify a safe and tolerable dose, monitors adverse events, measures tumor size by RECIST v1.1, and collects blood samples to study pharmacokinetics. Participants visit the clinic about eight times in the first eight weeks and then every three weeks for ongoing treatment and monitoring. Primary goals are safety, tolerability, how the drug behaves in the body, and preliminary evidence of tumor response.

Why it matters

Who can join: the full rules

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

Where it's running

• Mayo Clinic - Phoenix
  Phoenix, Arizona, United States Recruiting
• USC Norris Comprehensive Cancer Center
  Los Angeles, California, United States Recruiting
• Sarah Cannon Cancer Institute at HealthONE
  Denver, Colorado, United States Recruiting
• Yale Cancer Center- New Haven
  New Haven, Connecticut, United States Recruiting
• Mayo Clinic - Jacksonville
  Jacksonville, Florida, United States Recruiting
• Florida Cancer Specialists - Sarasota
  Sarasota, Florida, United States Recruiting

Study contacts

• Study coordinator: Kumquat Clinical Development
• Email: kumquatstudies@kumquatbio.com
• Phone: (858) 214-2700

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.