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

Kumquat Biosciences Inc.

Status and phase: Enrolling; Phase 1

Conditions: Solid Tumor Malignancies

Treatments: Drug: Pembrolizumab; Drug: KQB168

Study type: Interventional

Funder types: Industry

Identifiers

NCT06994806

KQB168-101

Details and patient eligibility

About

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

Enrollment: 84 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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84 participants in 2 patient groups

Monotherapy Dose Escalation

Experimental group

Description:

Drug: KQB168 - Oral KQB168

Treatment:

Drug: KQB168

Combo Therapy Dose Escalation

Experimental group

Description:

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

Treatment:

Drug: KQB168

Drug: Pembrolizumab