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A Study to Investigate the Safety and Efficacy of KQB365 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies
NCT06720987 · Kumquat Biosciences Inc.
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
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
About this study
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.
Eligibility criteria
Inclusion Criteria:
* PART 1 (monotherapy): Histologically confirmed diagnosis of a solid tumor malignancy with either a KRAS G12C or KRAS G12S mutation.
* PART 1 (combo therapy) \& PART 2: Histologically confirmed diagnosis of adenocarcinoma of the colon or rectum with either a KRAS G12C or KRAS G12S mutation.
* Unresectable or metastatic disease
* 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
* Active interstitial lung disease
Study design
Enrollment target: 128 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-02-04
Estimated completion: 2030-06-30
Last updated: 2025-07-11
Interventions
Drug: KQB365Drug: Cetuximab
Primary outcomes
- • Number of patients who experience treatment-emergent adverse events, serious adverse events, and dose-limiting toxicities (Part 1) (From enrollment to the end of treatment)
- • Recommended Phase 2 Dose (RP2D) (Part 1) (up to 35 months)
- • Efficacy and Optimal Biologic Dose of study treatment, as measured by Objective Response Rate (ORR) (Part 2) (up to 35 months)
Sponsor
Kumquat Biosciences Inc. · industry
Contacts & investigators
ContactKumquat Clinical Development · contact · kumquatstudies@kumquatbio.com · (858) 214-2700
All locations (9)
Mayo Clinic, PhoenixRecruiting
Phoenix, Arizona, United States
Sarah Cannon Cancer Institute at HealthONERecruiting
Denver, Colorado, United States
Mayo Clinic, JacksonvilleRecruiting
Jacksonville, Florida, United States
Dana Farber Cancer InstituteRecruiting
Boston, Massachusetts, United States
START MidwestRecruiting
Grand Rapids, Michigan, United States
Mayo Clinic, RochesterRecruiting
Rochester, Minnesota, United States
Cleveland Clinic, Taussig Cancer InstituteRecruiting
Cleveland, Ohio, United States
NEXT OncologyRecruiting
San Antonio, Texas, United States
NEXT Virginia, LLCRecruiting
Fairfax, Virginia, United States