Investigating KQB365 for treating advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the safety and efficacy of KQB365, both as a standalone treatment and in combination with cetuximab, for adults with advanced solid tumors harboring KRAS G12C or G12S mutations. Participants will receive weekly infusions of KQB365 and will undergo regular clinic visits to monitor their health and tumor response. The study will assess the safe dosage of KQB365, its effectiveness in reducing tumor size, and how the drug behaves in the body.

Why it matters

Who can join: the full rules

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.
* PART 1 (monotherapy Non-Small Cell Lung Cancer Cohort): Histologically confirmed diagnosis of Non-Small Cell Lung Cancer 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 it's running

• Mayo Clinic, Phoenix
  Phoenix, Arizona, United States Recruiting
• Sarah Cannon Cancer Institute at HealthONE
  Denver, Colorado, United States Recruiting
• Mayo Clinic, Jacksonville
  Jacksonville, Florida, United States Recruiting
• Dana Farber Cancer Institute
  Boston, Massachusetts, United States Recruiting
• START Midwest
  Grand Rapids, Michigan, United States Recruiting
• Mayo Clinic, Rochester
  Rochester, Minnesota, United States Recruiting

Study contacts

• Study coordinator: Kumquat Clinical Development
• Email: kumquatstudies@kumquatbio.com
• Phone: (858) 214-2700

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.