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AzTrials

Colorectal Cancer MetastaticPhase 2NCT06300463

Platform Study of Immunotherapy Combinations in Colorectal Cancer Liver Metastases

A Phase 2 study testing Botensilimab, Balstilimab and AGEN1423 in people with Colorectal Cancer Metastatic and Liver Metastases, run by Weill Medical College of Cornell University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Botensilimab, Balstilimab and AGEN1423
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteUnited States
Study dates
26 Mar 2024to Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Casey Owens contact

646-962-6046

cdo4001@med.cornell.edu

Myriam Elizaire-Williams contact

mye4001@med.cornell.edu

United States1 site, 1 recruiting

  • Weill Cornell Medicine/NewYork-Presbyterian Hospital

    New York, New York, 10065

    Casey Owens, 646-962-6046, cdo4001@med.cornell.edu

    Myriam Elizaire-Williams, mye4001@med.cornell.edu

    Recruiting

Other trials in United States

About this study

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
Read more

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.

Read the detailed description

This is a single-center, 3-arm, randomized, open-label, phase II, screening study to assess the initial immunological changes in the tumor microenvironment in response to treatment with combination immunotherapy (Botensilimab/ Balstilimab), with or without radiation and/or additional TGFβ-CD73 trap, in patients with colorectal cancer liver metastases.

Participants who meet eligibility criteria will be randomized to receive one of 3 investigational treatment: botensilimab + balstilimab (Arm 1); botensilimab + balstilimab + AGEN1423 (Arm 2); or botensilimab + balstilimab + radiation (Arm 3). The study arms are not directly or formally compared with each other. It is established that the tumor infiltrating lymphocytes have been predictive of patient survival following resection of colorectal cancer liver metastases. Immunotherapy combinations with an increase in the ratio of CD8+ T cells: Tregs will be considered for further investigation.

All participants will have a total of four treatment visits to receive immunotherapy infusions. Two visits will occur prior to surgery, each approximately 3 weeks apart. Surgery will be scheduled between day 28-42. After surgery, you will return for two more treatment visits. After the last dose of immunotherapy, participants will come to the clinic approximately 3 weeks and 3 months later for follow-up visits. Participants will be followed remotely for up to two years.

Being tested
Botensilimab, Balstilimab, AGEN1423, Radiation
Keywords
Botensilimab, Balstilimab, Immunotherapy
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BotensilimabDrug

    Also called AGEN1181

    75 mg IV Q6W

  • BalstilimabDrug

    Also called AGEN2034

    450 mg IV Q3W

  • AGEN1423Drug

    30 mg/kg IV Q3W

  • RadiationRadiation

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

Study groups in NCT06300463
Study groupRoleWhat they receive
Botensilimab and BalstilimabExperimentalTwo 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.
Receives: Drug: Botensilimab; Drug: Balstilimab
Botensilimab, Balstilimab, and AGEN1423ExperimentalTwo 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.
Receives: Drug: Botensilimab; Drug: Balstilimab; Drug: AGEN1423
Botensilimab, Balstilimab, and RadiationExperimentalParticipants 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.
Receives: Drug: Botensilimab; Drug: Balstilimab; Radiation: Radiation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean CD8:Treg ratio, as determined by flow cytometry of tumor tissue, at time of surgical resection in each treatment arm

    Preliminary immunological response to treatment will be assessed by comparison of the CD8:Treg ratios in tumor tissue obtained during standard of care surgical resection between treatment arms. CD8:Treg ratio will be assessed by flow cytometry

    Measured: At surgical resection

Secondary outcomes (4)

  1. Number of Treatment-Related Adverse Events (TRAEs) as assessed by CTCAE v5.0 per treatment arm

    Potentially treatment-related AEs include any AEs that are assessed as possibly, probably, or definitely related to one of the study interventions. AEs will be reported by CTCAE v5.0 term.

    Measured: 90 days following the last dose of study drug

  2. Pathological Response Rate Per Arm

    Resected tumors from the liver will be examined in their entirety, and regression of resected tumors was assessed by estimating the percentage of residual viable tumor of the macroscopically identifiable tumor bed, as identified on routine hematoxylin and eosin (H\&E) staining. In addition, regression will be classified using the Mandard tumor regression grading system. Major pathologic response (MPR) will be defined as ≤10% of residual viable tumor cells (or ≥ 90% response). PR will be defined as at least 50% tumor regression. Pathological response rate will be reported as the number of patients with MPR or PR.

    Measured: At surgical resection

  3. Radiographic Response Rate Per Arm

    Radiographic response will be evaluated based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Radiographic response rate will be reported as the number of patients with CR or PR.

    Measured: 90 days following the last dose of study drug

  4. Number of Participants Per Arm with ctDNA Clearance

    Circulating tumor DNA (ctDNA) will be assessed at 90 days following the last dose of study drug

    Measured: 90 days following the last dose of study drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Mar 2024
  2. Study start26 Mar 2024
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06300463
Sponsor's protocol ID
23-06026214
Status last verified
May 2026
First submitted
29 Feb 2024
Last updated
15 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Botensilimab, Balstilimab and AGEN1423 in people with Colorectal Cancer Metastatic and Liver Metastases, run by Weill Medical College of Cornell University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Casey Owens (646-962-6046, cdo4001@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06300463.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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