Testing a KRAS Vaccine With Immunotherapy for Advanced Pancreatic and Colorectal Cancer
Treatment
Phase 1b treatment study enrolling adults with advanced pancreatic or colorectal cancer that has a KRAS mutation and has been previously treated with chemotherapy
Clinicaltrials.gov identifier:NCT06411691
Study Contact Information:
For additional information, please contact:
Name: Colleen Apostol, RN
Phone Number: 410-614-3644
Email: [email protected]
About the Study
This study is testing a new treatment that combines a KRAS-targeted cancer vaccine (ELI-002) with two drugs (balstilimab and botensilimab) in people with advanced colorectal or pancreatic cancers.
This vaccine is designed to help the immune system recognize changes in a protein called KRAS, which is commonly involved in these cancers. The drugs are used to help the immune system better find and attack cancer cells.
Participants must have previously received chemotherapy for their cancer. The study is designed to determine how well this combination treatment works after initial therapy and whether it is safe and may slow or control cancer growth.
This Study is Open To:
This study is open to people who are 18 years old and older and meet the following criteria:
- Have pancreatic cancer or colorectal cancer that has spread and cannot be removed with surgery
- Have a tumor with a KRAS mutation that matches the study vaccine
- Have already received prior chemotherapy for their cancer
- Are healthy enough to participate based on lab tests and overall condition
- Are willing to attend study visits and undergo required testing
- For women, be non-pregnant and use contraceptives while in the study
- For men, use contraceptives while in the study
This Study is NOT Open To:
This study is not open to people who:
- Can have their cancer removed with surgery
- Have cancer that has spread to the brain or spinal fluid
- Have previously received certain treatment
- Have an active autoimmune condition or require medications that weaken the immune system
- Have certain serious or uncontrolled medical conditions
- Have active infections such as HIV, hepatitis B, or hepatitis C
- Have had major surgery or a live vaccine within 28 days of study treatment
- Are pregnant or breastfeeding
- Have certain complications such as fluid buildup (ascites/pleural effusion) or bowel obstruction
- Have a known allergy to the study drug (Hiltonol)
What the Study Involves
All participants will receive the study treatment.
- Participants will receive a KRAS-targeted vaccine (ELI-002) given as an injection to help stimulate the immune system to recognize cancer cells
- Participants will also receive drugs (balstilimab and botensilimab) given through an IV
- Treatment is given in cycles, with regular clinic visits for monitoring
Participants in the study will:
- Attend regular clinic visits for treatment and monitoring
- Undergo imaging scans (such as CT or ) to evaluate tumor response
- Have blood tests to monitor safety and immune response
- Provide tumor samples (biopsies) when possible
Treatment will continue as long as it is helping and side effects are manageable.
Study Contact Information:
For additional information, please contact:
Name: Colleen Apostol, RN
Phone Number: 410-614-3644
Email: [email protected]
Locations:
Maryland
City: Baltimore RECRUITING
Facility: Sidney Kimmel Comprehensive Cancer Center
Contact Info:
[email protected]
410-614-3644
Treatment
Phase 1b treatment study enrolling adults with advanced pancreatic or colorectal cancer that has a KRAS mutation and has been previously treated with chemotherapy
Clinicaltrials.gov identifier:NCT06411691
Study Contact Information:
For additional information, please contact:
Name: Colleen Apostol, RN
Phone Number: 410-614-3644
Email: [email protected]