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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
128
Mayo Clinic, Phoenix
Phoenix, Arizona, United States
RECRUITINGSarah Cannon Cancer Institute at HealthONE
Denver, Colorado, United States
RECRUITINGMayo Clinic, Jacksonville
Jacksonville, Florida, United States
RECRUITINGDana Farber Cancer Institute
Boston, Massachusetts, United States
RECRUITINGSTART Midwest
Grand Rapids, Michigan, United States
RECRUITINGMayo Clinic, Rochester
Rochester, Minnesota, United States
RECRUITINGCleveland Clinic, Taussig Cancer Institute
Cleveland, Ohio, United States
RECRUITINGNEXT Oncology
San Antonio, Texas, United States
RECRUITINGNEXT Virginia, LLC
Fairfax, Virginia, United States
RECRUITINGNumber of patients who experience treatment-emergent adverse events, serious adverse events, and dose-limiting toxicities (Part 1)
Safety characterized by type, incidence, severity, timing, seriousness and relationship to study treatment of AEs, SAEs, and DLTs, from first dose of study treatment to 30 days after last dose of study treatment.
Time frame: From enrollment to the end of treatment
Recommended Phase 2 Dose (RP2D) (Part 1)
Evaluate safety and assess number of patients with dose-limiting toxicity to determine the RP2D.
Time frame: up to 35 months
Efficacy and Optimal Biologic Dose of study treatment, as measured by Objective Response Rate (ORR) (Part 2)
ORR is the proportion of subjects that experience confirmed complete response (CR) or partial response (PR) based on RECIST v1.1 during the time period from 1st dose of study treatment until last dose.
Time frame: up to 35 months
Concentration-time curve (AUC)
Time frame: up to 35 months
Maximum plasma concentration (Cmax)
Time frame: up to 35 months
Time to maximum plasma concentration (tmax)
Time frame: up to 35 months
Overall survival (OS)
Time frame: up to 35 months
Progression-free survival (PFS)
using RECIST v1.1
Time frame: up to 35 months
Overall response rate (ORR)
using RECIST v1.1
Time frame: up to 35 months
Duration of response (DOR)
using RECIST v1.1
Time frame: up to 35 months
Time to response (TTR)
using RECIST v1.1
Time frame: up to 35 months
Disease control rate (DCR)
using RECIST v1.1
Time frame: up to 35 months
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