NCT06720987 · Kumquat Biosciences Inc.
A Study to Investigate the Safety and Efficacy of KQB365 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
KQB365
Intravenous KQB365
DRUG
Cetuximab
Intravenous cetuximab
DRUG
KQB198
Oral KQB198
Primary outcome measures
Number of patients who experience treatment-emergent adverse events, serious adverse events, and dose-limiting toxicities (Part 1)
Time frame: From enrollment to the end of treatment
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.
Recommended Phase 2 Dose (RP2D) (Part 1)
Time frame: up to 35 months
Evaluate safety and assess number of patients with dose-limiting toxicity to determine the RP2D.
Efficacy and Optimal Biologic Dose of study treatment, as measured by Objective Response Rate (ORR) (Part 2)
Time frame: up to 35 months
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- PART 1 (monotherapy and combo therapy with KQB198): Histologically confirmed diagnosis of a solid tumor malignancy with either a KRAS G12C or KRAS G12S mutation.
- PART 1 (combo therapy with Cetuximab) \& 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
- Unable to swallow or GI condition that prevents absorption for patients in KQB198 combination cohorts
Where
- Phoenix, Arizona
- Denver, Colorado
- Jacksonville, Florida
- Boston, Massachusetts
- Grand Rapids, Michigan
- Rochester, Minnesota
- Cleveland, Ohio
- Oklahoma City, Oklahoma
- Philadelphia, Pennsylvania
- San Antonio, Texas
- Fairfax, Virginia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 23, 2026 · Source of record for eligibility and locations