Recruiting
Phase 2

Immunotherapy Combinations

Sponsor:

Weill Medical College of Cornell University

Code:

NCT06300463

Conditions

Colorectal Cancer Metastatic

Liver Metastases

Colorectal Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Botensilimab

Balstilimab

AGEN1423

Radiation

Study Details

Brief summary:

The goal of this clinical trial is to to learn about different combinations of immunotherapy in patients with colorectal cancer whose cancer has spread to their liver and are planning to have surgery to remove tumor metastases from their liver. The main questions it aims to answer are:

  • whether these combinations of immunotherapy change the tumor microenvironment in the liver
  • whether these combinations of immunotherapy are safe and effective when used in colorectal cancer with liver metastases

Participants will be randomly assigned to one of the following:

  • Botensilimab and balstilimab
  • Botensilimab, balstilimab, and AGEN1423
  • Botensilimab, balstilimab, and radiation

Participants will be asked to come in to receive drug infusions (and radiation, if applicable) before and after their surgical resection. Participants will be followed for up to 2 years.

Conditions

Colorectal Cancer Metastatic

Liver Metastases

Colorectal Cancer

Study ID

NCT06300463

Start date

Mar 26, 2024

Status verified date

May, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Diagnosis of metastatic colorectal adenocarcinoma with liver metastases
  • Participant must be planning to undergo a surgical resection of their liver metastases.
  • Tumor is non-MSI-H/dMMR
  • Presence of measurable disease
  • Participants must be willing to consent to additional molecular analyses of tumor samples removed during surgery for research purposes
  • Women of childbearing potential (WOCBP), or anyone with a uterus, must not be pregnant or breastfeeding. All participants of childbearing potential must agree to use highly effective contraception during this study
  • Participants may not receive chemotherapy, growth factor support, transfusions, or albumin administration within 14 days of start of study treatment.

Exclusion Criteria:

  • Not eligible for surgery
  • Any medical condition such as uncontrolled infection, uncontrolled diabetes mellitus or cardiac disease which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient.
  • Previous allogeneic tissue/organ transplant
  • Previously received PD-1, PD-L1, or CTLA-4 therapy including experimental immunologic agents
  • Participants must not have any contraindications to immune checkpoint inhibitors
  • Participants must not have active autoimmune disease that has required systemic treatment within 2 years prior to registration. Some exceptions are allowed

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Botensilimab and Balstilimab

Two balstilimab infusions will be given prior to surgery and two infusions will be given after surgery, for a total of four doses. Each infusion will be scheduled approximately 3 weeks apart. On the same day as the first and third balstilimab infusions, botensilimab will also be given, for a total of two doses, one before and one after surgery.

experimental: Botensilimab, Balstilimab, and AGEN1423

Two balstilimab infusions will be given prior to surgery and two infusions will be given after surgery, for a total of four doses. On the same day as each balstilimab infusion, participants will also receive AGEN1423 infusions, for a total of four doses. Each infusion will be scheduled approximately 3 weeks apart. On the same day as the first and third balstilimab + AGEN1423 infusions, botensilimab will also be given, for a total of two doses, one before and one after surgery.

experimental: Botensilimab, Balstilimab, and Radiation

Participants will receive 3 doses of radiation prior to surgery. Additionally, two balstilimab infusions will be given prior to surgery and two infusions will be given after surgery, for a total of four doses. Each infusion will be scheduled approximately 3 weeks apart. On the same day as the first and third balstilimab infusions, botensilimab will also be given, for a total of two doses, one before and one after surgery.

Interventions

Botensilimab

75 mg IV Q6W

Balstilimab

450 mg IV Q3W

AGEN1423

30 mg/kg IV Q3W

Radiation

8Gy x 3 between Day 0 - 18; Allowed techniques for radiation are 3D conformal, intensity modulated radiotherapy (IMRT), or SBRT

Primary outcome measure

  • Mean CD8:Treg ratio, as determined by flow cytometry of tumor tissue, at time of surgical resection in each treatment arm [ Time Frame: At surgical resection ]

Central Contacts and Locations

Central contacts

Casey Owens

646-962-6046cdo4001@med.cornell.edu

Myriam Elizaire-Williams

mye4001@med.cornell.edu

Locations

Weill Cornell Medicine/NewYork-Presbyterian Hospital

Recruiting

New York, New York, United States, 10065

Contacts

Casey Owens

646-962-6046cdo4001@med.cornell.edu

Myriam Elizaire-Williams

mye4001@med.cornell.edu

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

May 15, 2026

Last verified

May, 2026

Keywords

  • Botensilimab
  • Balstilimab
  • Immunotherapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2026-05-15.