RecruitingPhase 1NCT06720987

A Study to Investigate the Safety and Efficacy of KQB365 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies

A Phase 1/1b, Open-label, Multicenter, Dose Escalation and Dose Optimization Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of KQB365 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Malignancies With KRAS G12S or G12C Mutations


Sponsor

Kumquat Biosciences Inc.

Enrollment

140 participants

Start Date

Feb 4, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to learn if KQB365 works to treat advanced solid tumor cancer in adults. It will also learn about the safety of KQB365. The main questions it aims to answer are: * What is the safe dose of KQB365 by itself, in combination with cetuximab, or in combination with KQB198? * Does KQB365 alone, in combination with cetuximab, or in combination with KQB198 decrease the size of the tumor? * What happens to KQB365 in the body? Participants will: * Receive KQB365 infusion weekly alone, in combination with cetuximab, or in combination with oral KQB198. * Visit the clinic about 9 times in the first 6 weeks, and then once every week after that.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called KQB365, which targets a specific cancer-driving gene mutation called KRAS G12C or G12S. Researchers are testing it both as a standalone treatment and in combination with other therapies, with a focus on colorectal cancer and other solid tumors that carry these mutations. **You may be eligible if...** - You have been diagnosed with a solid tumor (such as colorectal cancer) confirmed by biopsy - Your tumor has a KRAS G12C or KRAS G12S mutation (your oncologist can test for this) - Your cancer cannot be surgically removed or has spread to other parts of the body - There are no other treatments available that could cure your cancer - Your blood counts and organ function are adequate - You have measurable disease on imaging **You may NOT be eligible if...** - You have active tumors in your brain or spinal cord (central nervous system) - You have significant heart rhythm or cardiac problems - You have active inflammatory lung disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGKQB365

Intravenous KQB365

DRUGCetuximab

Intravenous cetuximab

DRUGKQB198

Oral KQB198


Locations(11)

Mayo Clinic, Phoenix

Phoenix, Arizona, United States

Sarah Cannon Cancer Institute at HealthONE

Denver, Colorado, United States

Mayo Clinic, Jacksonville

Jacksonville, Florida, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

START Midwest

Grand Rapids, Michigan, United States

Mayo Clinic, Rochester

Rochester, Minnesota, United States

Cleveland Clinic, Taussig Cancer Institute

Cleveland, Ohio, United States

OU Health Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

Sydney Kimmel Cancer Center

Philadelphia, Pennsylvania, United States

NEXT Oncology

San Antonio, Texas, United States

NEXT Virginia, LLC

Fairfax, Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT06720987


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