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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-24

Study Completion Date

2028-05-31

Brief Summary

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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

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Detailed Description

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Conditions

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Solid Tumor Malignancies

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Monotherapy Dose Escalation

Drug: KQB168 - Oral KQB168

Group Type EXPERIMENTAL

KQB168

Intervention Type DRUG

Oral KQB168

Combo Therapy Dose Escalation

Drug: KQB168 - Oral KQB168 Drug: pembrolizumab - Intravenous pembrolizumab

Group Type EXPERIMENTAL

KQB168

Intervention Type DRUG

Oral KQB168

Pembrolizumab

Intervention Type DRUG

Intravenous pembrolizumab

Interventions

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KQB168

Oral KQB168

Intervention Type DRUG

Pembrolizumab

Intravenous pembrolizumab

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No