Intermediate-size IND for Treatment of KRAS G12V-mutant Tumors

NCT05389514 | Unknown

• 1 other identifier: 2020000471
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This intermediate-size IND will treat participants with incurable, advanced or metastatic cancer, harboring KRAS G12V mutation and appropriate HLA class II match (HLA-DRB1\*07:01).

Conditions

KRAS G12V Mutant Advanced Epithelial Cancers

Interventions

Cyclophosphamide DRUG

Patients will receive a single dose of cyclophosphamide 60 mg/kg IV in 250 ml D5W over 2 hours on Day -3.

Also known as: Cytoxan, Cytoxan Lyophilized, Cy

Gemcitabine DRUG

Patients will receive a single dose of gemcitabine 600 mg/mg2 IVPB over 30 minutes on Day -2.

Also known as: Gemzar

Pembrolizumab DRUG

Patients will receive the anti-PD-1 immune checkpoint inhibitor pembrolizumab 200 mg IV over 30 minutes on Day -1 and will be dosed every 3 weeks.

Also known as: KEYTRUDA, MK-3475

Cell Infusion BIOLOGICAL

Patient's T cells will be administered at a dose of between 1 x 10\^9 to 5.0 x 10\^10 TCR-transduced lymphocytes, which is a dose of genetically modified T cells that can be safely administered and is capable of mediating tumor regression in some patients with metastatic cancers. The cells are to be infused intravenously over approximately 30 minutes via non-filtered tubing, gently agitating the bag during infusion to prevent cell clumping.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

Patients with incurable, advanced or metastatic cancer, harboring KRAS G12V mutation, and appropriate HLA class II match (HLA-DRB1\*07:01)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Providence Health & Services: lead

MeSH Terms

Interventions

Cyclophosphamide; Gemcitabine; pembrolizumab; Insulin Infusion Systems

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Drug Delivery Systems; Drug Therapy; Therapeutics; Infusion Pumps; Equipment and Supplies; Artificial Organs; Surgical Equipment

Study Officials

• Matthew Taylor, MD

  Providence Health & Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: expanded access
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2022
• First Posted: May 25, 2022
• Last Updated: November 20, 2025

Record last verified: 2025-11