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New treatment option for Metastatic Colorectal Adenocarcinoma
Official title Botensilimab Plus Balstilimab and Fasting Mimicking Diet Plus Vitamin C for Patients With KRAS-Mutant Metastatic Colorectal Cancer
ClinicalTrials.gov ID: NCT06336902
What this study is testing
What is Balstilimab?
Balstilimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for metastatic colorectal adenocarcinoma.
Also referred to as AGEN 2034, AGEN-2034.
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
- This phase Ib trial tests the safety, side effects, and effectiveness of botensilimab, and balstilimab in combination with a fasting mimicking diet and high dose vitamin C in treating patients with KRAS-mutant metastatic colorectal cancer. Botensilimab and balstilimab are monoclonal antibodies that may interfere with the ability of tumor cells to grow and spread.
- Phase 1: an early, usually small safety study
- Time commitment: about 2 years
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
- Histologically or cytologically confirmed microsatellite stable (MSS) metastatic colorectal adenocarcinoma with any KRAS mutation (as determined by a...
- Disease progression, intolerance or contraindication to a fluoropyrimidine, oxaliplatin, irinotecan
- ≥ 18 years of age
- Performance status Eastern Cooperative Oncology Group (ECOG) 0-1
- Estimated life expectancy ≥ 3 months
You likely can't join if
- Patients with a current diagnosis of diabetes mellitus are not eligible for this study. Note: Patients with pre-diabetes or previous diabetes or...
- Patients taking medications that cannot be safely stopped during the fasting periods or which may not be safely taken without food are not eligible...
- Received prior systemic cytotoxic chemotherapy, biological therapy, radiotherapy, or major surgery within 3 weeks prior to first dose of study drug...
- History of syncope with caloric restriction or another medical comorbidity which would make fasting potentially dangerous
- Current use of oral vitamin C supplements
- Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an...
See the full eligibility criteria
Who can join
- Histologically or cytologically confirmed microsatellite stable (MSS) metastatic colorectal adenocarcinoma with any KRAS mutation (as determined by a Clinical Laboratory Improvement Act [CLIA]-certified lab), including...
- Disease progression, intolerance or contraindication to a fluoropyrimidine, oxaliplatin, irinotecan
- ≥ 18 years of age
- Performance status Eastern Cooperative Oncology Group (ECOG) 0-1
- Estimated life expectancy ≥ 3 months
- Body mass index (BMI) ≥ 18.5
- Absolute neutrophil count ≥ 1,500/mcL
- Hemoglobin ≥ 8.0 g/dL
- Platelets ≥ 75,000/mcL
- Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (for patients with Gilbert syndrome ≤ 3.0 x ULN)
- Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) ≤ 3 x ULN
- Creatinine ≤ 1.5 x ULN
- Measurable disease as defined by RECIST 1.1
- No history of prior or current malignancy that requires active treatment
- Female patients of childbearing potential must be willing to use highly effective contraceptive measures starting with the Screening visit through 90 days after last dose of study treatment. Note: Abstinence is...
- Female patients of childbearing potential must have a negative serum pregnancy test at screening (within 72 hours of first dose of study medication). Non-childbearing potential is defined as 1 of the following:
- ≥ 45 years of age and has not had menses for \> 1 year
- Amenorrheic for \> 2 years without a hysterectomy and/or oophorectomy and follicle stimulating hormone value in the postmenopausal range upon pretrial (screening) evaluation
- Status is post-hysterectomy, -oophorectomy, or -tubal ligation
- Male patients with a female partner(s) of childbearing potential must agree to use highly effective contraceptive measures throughout the trial starting with the Screening visit through 90 days after the last dose of...
What rules you out
- Patients with a current diagnosis of diabetes mellitus are not eligible for this study. Note: Patients with pre-diabetes or previous diabetes or glucose intolerance and who are currently not taking any diabetes...
- Patients taking medications that cannot be safely stopped during the fasting periods or which may not be safely taken without food are not eligible for this study
- Received prior systemic cytotoxic chemotherapy, biological therapy, radiotherapy, or major surgery within 3 weeks prior to first dose of study drug. A 1-week washout is permitted for palliative radiation to non-central...
- History of syncope with caloric restriction or another medical comorbidity which would make fasting potentially dangerous
- Current use of oral vitamin C supplements
- Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigation device within 3 weeks of first dose of current study drug
- Expected to require any other form of systemic or localized antineoplastic therapy while on trial (including maintenance therapy with another agent, radiation therapy, and/or surgical resection)
- History of anti-PD1 or anti-CTLA4 therapy
- Unresolved toxicity ≥ CTCAE grade 2 except for neuropathy, alopecia
- Untreated brain or leptomeningeal metastases or previously treated CNS metastases with any of the following: residual neurologic deficit; history of seizures; ongoing requirement of steroids, exceeding prednisone 10 mg...
- Patients who have uncontrolled or severe hyponatremia, hypernatremia, syndrome of inappropriate antidiuretic hormone secretion (SIADH), hypokalemia, hyperkalemia, hypomagnesemia, or hypermagnesemia
- Patients who have glucose-6-phosphate dehydrogenase (G6PD) deficiency, hereditary spherocytosis, or other conditions predisposing patient to hemolysis
- Patients who have a history of oxalate renal calculi
- Major surgery within 4 weeks of first dose of immunotherapy
- Known severe (grade ≥ 3) hypersensitivity reactions to fully human monoclonal antibodies, antibody, or severe reaction to immuno-oncology agents, such as colitis or pneumonitis requiring treatment with steroids; or has...
- Evidence of bleeding diathesis or clinically significant coagulopathy
- Receiving systemic corticosteroid therapy 1 week prior to the first dose of study drug or receiving any other form of systemic immunosuppressive medication. Note: Corticosteroid use as a premedication for IV contrast...
- Active or history of autoimmune disease that requires systemic treatment within 2 years of the start of study drug (i.e., use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Note: Patients...
- Has had an allogeneic tissue/solid organ transplant, except for corneal transplants
- Legally incapacitated or has limited legal capacity
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, active coronary artery disease, myocardial infarction or cerebrovascular accident...
The study team makes the final eligibility decision.
Where it's taking place
- Fullerton, California, United States
- Los Angeles, 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 - confirm specifics with the study team.
How long does this study last?
The study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you 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?
Study sites include Fullerton, California, United States; Los Angeles, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.