Clinical trial for Colorectal Cancer Metastatic
Official title BAL/BOT/agenT-797 in pMMR CRC With Liver Metastases
ClinicalTrials.gov ID: NCT07550088
What this study is testing
What is Balstilimab?
It is an investigational medicine being studied as a potential treatment for metastatic colorectal cancer. It is designed to help the immune system recognize and attack cancer cells by blocking a specific protein called PD-1.
Also referred to as AGEN2034.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see if the combination of balstilimab, botensilimab, and agenT-797 can shrink tumors and what side effects it causes.
- Who it's for
- Adults who have already tried other treatments for metastatic colorectal cancer that is microsatellite stable and has liver metastases.
- What's involved
- All participants receive the drug combo every 42 days, have imaging scans, blood tests, and tumor tissue samples taken, and are monitored for side effects.
- Time commitment
- The study lasts until treatment ends, with regular visits for scans, blood work, and follow‑up after treatment to check survival.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adults ≥18 years of age with histologically confirmed metastatic colorectal cancer with liver metastases, including evidence of active liver disease...
- At least one measurable lesion per RECIST v1.1, with ≥1 target lesion in the liver
- Tumor confirmed as microsatellite stable (MSS)/proficient mismatch repair (pMMR) per a FDA-approved assay (Caris MI Cancer Seek®, FoundationOne® CDx...
- Received ≥1 prior line of systemic therapy including fluorouracil, oxaliplatin, and irinotecan (not necessarily in combination), and prior EGFR...
- ECOG performance status 0-1 and life expectancy ≥12 weeks
You likely can't join if
- Tumor is dMMR/MSI-high
- Prior treatment with PD-1, PD-L1, CTLA-4 inhibitors, or other immunotherapy agents
- Evidence of bowel obstruction, impending obstruction, or recent obstruction (within 3 months)
- Refractory ascites requiring frequent paracentesis or recent escalation of diuretics
- Clinically significant cardiovascular disease (e.g., recent myocardial infarction or stroke, unstable angina, NYHA class ≥III heart failure...
- Active or untreated brain metastases or leptomeningeal disease
See the full eligibility criteria
- Adults ≥18 years of age with histologically confirmed metastatic colorectal cancer with liver metastases, including evidence of active liver disease if previously treated locally
- At least one measurable lesion per RECIST v1.1, with ≥1 target lesion in the liver
- Tumor confirmed as microsatellite stable (MSS)/proficient mismatch repair (pMMR) per a FDA-approved assay (Caris MI Cancer Seek®, FoundationOne® CDx, or Tempus xT CDx).
- Received ≥1 prior line of systemic therapy including fluorouracil, oxaliplatin, and irinotecan (not necessarily in combination), and prior EGFR inhibitor or bevacizumab if eligible, unless contraindicated
- ECOG performance status 0-1 and life expectancy ≥12 weeks
- ANC ≥1.5 × 10⁹/L
- Platelets ≥100 × 10⁹/L
- Hemoglobin ≥ 9 g/dL
- AST/ALT ≤2.5 × ULN
- Total bilirubin ≤1.5 × ULN
- Creatinine clearance ≥ 40 mL/min, as measured or calculated per local institutional standards.
- Albumin ≥3 g/dL
- PT/PTT ≤1.5 × ULN
- Willing and able to provide written informed consent
- Negative pregnancy test for women of childbearing potential
- Agreement to use effective contraception during study participation
- Tumor is dMMR/MSI-high
- Prior treatment with PD-1, PD-L1, CTLA-4 inhibitors, or other immunotherapy agents
- Evidence of bowel obstruction, impending obstruction, or recent obstruction (within 3 months)
- Refractory ascites requiring frequent paracentesis or recent escalation of diuretics
- Clinically significant cardiovascular disease (e.g., recent myocardial infarction or stroke, unstable angina, NYHA class ≥III heart failure, uncontrolled arrhythmias) or QTc \>480 ms
- Active or untreated brain metastases or leptomeningeal disease
- Concurrent malignancy requiring treatment or active within 2 years (with protocol-specified exceptions)
- Cytotoxic, targeted therapy or other investigational therapy within 3 weeks.
- Monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugates, or similar therapy, within 4 weeks, or 5 half-lives, whichever is shorter.
- Small molecules/tyrosine kinase inhibitors within 2 weeks or less than 5 circulating half-lives of investigational drug.
- Known hypersensitivity to study drugs or excipients
- History of or active interstitial lung disease or pneumonitis requiring systemic steroids
- Prior allogeneic transplant (organ, stem cell, or bone marrow)
- Active or recent autoimmune disease requiring systemic treatment
- Requirement for systemic corticosteroids (\>10 mg prednisone equivalent) or other immunosuppressive therapy within defined windows
- Active infection, including HIV, HTLV, HBV, HCV, or other infections requiring systemic therapy
- Recent SARS-CoV-2 infection within protocol-defined timeframe
- Uncontrolled hypertension, significant proteinuria (UPCR ≥1 g/g), or other clinically significant uncontrolled medical conditions
- Non-healing wounds, active bleeding, or uncontrolled thyroid dysfunction
- Psychiatric or substance use disorders that may interfere with study participation
- Receipt of live or attenuated vaccines within 30 days prior to treatment and while participating in the study
- Pregnant or breastfeeding women, or those planning pregnancy during the study
The study team makes the final eligibility decision.
Where it is enrolling
- La Jolla, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at La Jolla, California, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.