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RECRUITING
NCT06720987
PHASE1

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

Sponsor: Kumquat Biosciences Inc.

View on ClinicalTrials.gov

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 or in combination with cetuximab? * Does KQB365 alone or in combination with cetuximab decrease the size of the tumor? * What happens to KQB365 in the body? Participants will: * Receive KQB365 infusion weekly alone or in combination with cetuximab * Visit the clinic about 9 times in the first 6 weeks, and then once every week after that.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

128

Start Date

2025-02-04

Completion Date

2030-06-30

Last Updated

2025-07-11

Healthy Volunteers

No

Interventions

DRUG

KQB365

Intravenous KQB365

DRUG

Cetuximab

Intravenous cetuximab

Locations (9)

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

NEXT Oncology

San Antonio, Texas, United States

NEXT Virginia, LLC

Fairfax, Virginia, United States