RECRUITING

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

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

Conditions

Solid Tumor Malignancies
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Related Conditions:

Solid Tumor Malignancies

Study Overview

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Study Details

Study overview

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

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

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

Condition
Solid Tumor Malignancies
Intervention / Treatment

-

Contacts and Locations

Austin

NEXT Austin, Austin, Texas, United States, 78758

Houston

NEXT Huston, Houston, Texas, United States, 77054

San Antonio

NEXT Oncology, San Antonio, Texas, United States, 78229

Fairfax

NEXT Virginia, Fairfax, Virginia, United States, 22031

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Kumquat Biosciences Inc.,

Study Record Dates

2028-05-31