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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorKumquat Biosciences Inc.

About this trial

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 criteria

Qualifiers

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

Disqualifiers

Active primary central nervous system tumors

Cardiac abnormalities

History of lung diseases

Any condition that may impair drug absorption or prevent oral dosing

Trial design

Treatments tested in this trial

  • KQB168
  • Pembrolizumab

Treatment groups

84 Participants
are divided into 2 treatment groups

Sponsors and collaborators