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

Recruiting now · Phase 1

Conditions studied: KRAS G12C Mutation, KRAS G12S Mutation, Solid Tumor Malignancies, CRC (Colorectal Cancer)

In brief

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.

Key facts

Study ID

NCT06720987

Run by

Kumquat Biosciences Inc.

People needed

140

Starts

2025-02-04

Expected to finish

2030-06-30

Last updated by the study team

2026-04-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• Mayo Clinic, Phoenix — Phoenix, Arizona, United States (enrolling)
• Sarah Cannon Cancer Institute at HealthONE — Denver, Colorado, United States (enrolling)
• Mayo Clinic, Jacksonville — Jacksonville, Florida, United States (enrolling)
• Dana Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
• START Midwest — Grand Rapids, Michigan, United States (enrolling)
• Mayo Clinic, Rochester — Rochester, Minnesota, United States (enrolling)
• Cleveland Clinic, Taussig Cancer Institute — Cleveland, Ohio, United States (enrolling)
• OU Health Stephenson Cancer Center — Oklahoma City, Oklahoma, United States (enrolling)
• Sydney Kimmel Cancer Center — Philadelphia, Pennsylvania, United States (enrolling)
• NEXT Oncology — San Antonio, Texas, United States (enrolling)
• NEXT Virginia, LLC — Fairfax, Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.