Implantable Microdevice for Colorectal Cancer

Overseen By Micaela Wigfall Maxwell

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Northwell Health

Disqualifiers: Pregnancy, Second primary malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a tiny implantable device to evaluate its effectiveness in delivering cancer-fighting drugs directly to liver tumors from colorectal cancer. The goal is to determine if the drugs spread effectively from the device into the tumor tissue and to ensure the device can be safely implanted and removed. Eligible patients must have confirmed colorectal cancer that has spread to the liver and must be planning to undergo liver surgery. The study focuses on ensuring the procedure's safety and the drugs' positive effect on the tumor. As an Early Phase 1 trial, patients will be among the first to receive this innovative treatment, aiding researchers in understanding its function in people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this microdevice is safe for patients with liver metastasis from colorectal cancer?

Research has shown that the treatments used in this trial have been safe in the past. For instance, bevacizumab, when combined with chemotherapy, has extended the lives of patients with advanced colorectal cancer, demonstrating its safe use in many patients.

Another combination, botensilimab and balstilimab, has also been tested and found safe, with no unexpected or severe side effects reported in previous studies.

These findings suggest that the treatments in this trial have been well-tolerated in past studies with other cancer patients. However, it is important to note that this trial is in its early stages, and safety is still under careful study, especially since the treatment involves a new device placed in the body. Participants will be closely monitored for any issues after the device is inserted and later removed during surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the implantable microdevice for colorectal cancer because it introduces a novel way to deliver multiple chemotherapeutic agents directly to the tumor site. Unlike traditional systemic therapies that circulate throughout the body, this device allows for localized treatment, potentially increasing drug effectiveness while minimizing side effects. Additionally, the microdevice can be loaded with a combination of drugs, like AGEN2373, Balstilimab, and Bevacizumab, offering a multifaceted attack on the cancer cells. This innovative approach could revolutionize how colorectal cancer is treated by providing a more targeted and efficient therapy option.

What evidence suggests that this microdevice is effective for colorectal liver metastasis?

Research has shown that bevacizumab can enhance the effects of other cancer treatments and help manage advanced colorectal cancer. Botensilimab and balstilimab have also demonstrated potential, with patients living an average of 21 months. However, success rates for these treatments vary, particularly in advanced cases. In this trial, the implantable microdevice delivers these and other chemotherapy drugs directly to the tumor, potentially increasing their effectiveness. This method could improve how the drugs reach and affect cancer cells in the liver. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for patients with colorectal cancer that has spread to the liver. Participants must be scheduled for surgical removal of these liver tumors and willing to have a microdevice implanted and later removed during surgery.

Inclusion Criteria

Feasibility of microdevice implantation based on clinical history and extent/anatomical location of the CLM tumor as evaluated by the operating surgical oncologist and interventional radiologist on baseline imaging

Ability to understand and willingness to sign informed consent for both the surgical resection and the proposed research study prior to any procedures

Mothers must discontinue breastfeeding for 14 days after the insertion of the microdevice

Exclusion Criteria

Tumor location not amenable to device placement

I am not pregnant at the time of joining the study or undergoing surgery.

I do not have another cancer that could affect the trial's safety or results.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Device Implantation

Percutaneous placement of the microdevice 3-5 days prior to scheduled resection of colorectal liver metastasis

1 week

1 visit (in-person)

Surgical Retrieval

Surgical retrieval of the microdevice en bloc with the tumor during the scheduled resection

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after device retrieval, ensuring no increased complication rates within 14 days of surgery

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AGEN2373
• Balstilimab
• Bevacizumab
• Botensilimab
• Doxorubicin
• FOLFIRI
• FOLFIRINOX
• FOLFOX

Trial Overview The study tests an implantable microdevice's safety in delivering various drugs directly into liver tumors. Drugs tested include Doxorubicin, FOLFOX, Botensilimab, Balstilimab, Bevacizumab, FOLFIRI, FOLFIRINOX, AGEN2373.

How Is the Trial Designed?

Group I: Single Arm Experimental Treatment 1 Intervention

Subjects will have the device placed loaded with chemotherapeutic agents.

Who Is Running the Clinical Trial?

Northwell Health

Lead Sponsor

Trials

481

Recruited

470,000+

Citations

1. investor.agenusbio.com investor.agenusbio.com/news/news-details/2025/Agenus-Presents-Data-at-ASCO-GI-Demonstrating-Impact-of-BOTBAL-in-Colorectal-Cancer-Across-Neoadjuvant-and-Advanced-Disease/default.aspx

Agenus Presents Data at ASCO GI Demonstrating Impact ... Data from five presentations underscore the transformative potential of BOT/BAL across multiple lines of therapy in colorectal cancer.

2. nature.com nature.com/articles/s41591-024-03083-7

Botensilimab plus balstilimab in relapsed/refractory ... However, response rates vary across tumor types, with particularly disappointing outcomes in patients with metastatic colorectal cancer (mCRC) ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06268015

NCT06268015 | Botensilimab and Balstilimab Optimization ... Histologically confirmed metastatic and/or unresectable colorectal cancer without liver metastasis or known or suspected bone or brain metastases. a. Up to 3 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10832121/

Effectiveness of bevacizumab in the treatment of metastatic ... The addition of BEV can enhance the anti-tumor ability and disease control, while cetuximab and panitumumab may have stronger ability.

5. oncodaily.com oncodaily.com/oncolibrary/botensilimab-balstilimab-esmo-gi-2025

Botensilimab and Balstilimab Show Durable Survival in ... Botensilimab plus balstilimab delivers 21-month overall survival in MSS colorectal cancer, per updated Phase 1b data at ESMO GI 2025.

6. investor.agenusbio.com investor.agenusbio.com/news/news-details/2025/Agenus-Reports-Q3-2025-Results-Showcasing-Clinical-and-Regulatory-Advances/default.aspx

Agenus Reports Q3 2025 Results Showcasing Clinical and ... BOT/BAL has demonstrated durable, long-term survival in patients with advanced solid tumors, reinforcing its potential to expand the reach of ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3780632/

Efficacy and Safety of Bevacizumab in Metastatic ... The use of bevacizumab with chemotherapy resulted in statistically significant increases in overall and progression-free survival for patients with mCRC.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05627635

Study Details | NCT05627635 | FOLFOX and Bevacizumab ... The combination of these drugs may lead to improved disease control and outcomes in patients with MSS metastatic colorectal cancer. Detailed Description.

9. ir.merus.nl ir.merus.nl/news-releases/news-release-details/merus-interim-data-petosemtamab-metastatic-colorectal-cancer

Merus' Interim Data on Petosemtamab in Metastatic ... 100% response rate in 1L left-sided mCRC (n=8, confirmed and unconfirmed). – 62% response rate in 2L left- and right-sided mCRC (n=13, ...