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New treatment option for Breast Carcinoma
Official title Immune Response Activation for the Treatment of Unresectable Metastatic Colorectal Cancer or CEA Positive Metastatic Breast Cancer
ClinicalTrials.gov ID: NCT06130826
What this study is testing
What is Immunotherapy?
Immunotherapy is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for breast carcinoma.
Also referred to as Immunological, Immunological Therapy.
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 I trial studies the side effects and best dose of M5A-IL2 immunocytokine (M5A-ICK) combined with stereotactic body radiation therapy (SBRT) and to see how well they work in treating patients with colorectal cancer or xarcinoembryonic antigen (CEA) positive breast cancer that cannot be removed by surgery (unresectable) or has spread from where it first started (primary site) to other places in the body (metastatic). Carcinoembryonic Antigen (CEA) is a protein that is present in most colorectal cancers and in many other cancers, such as breast cancer, as well.
- Phase 1: an early, usually small safety study
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
- Patients should have a diagnosis of metastatic colon or rectal or breast cancer that is pathology proven
- Patients should have a CEA producing colorectal cancer or breast cancer defined as a baseline CEA or prior documented CEA level exceeding 5 ng/ml or...
- Patients should 18 years of age or older
- Patients are willing and capable to consent to study and to adhere with all elements of the study
- Patients who have failed to respond to standard systemic therapy, or for whom standard or curative systemic therapy does not exist, is not tolerable...
You likely can't join if
- Patients on immunosuppressive treatments including supra-physiological doses of corticosteroids
- Patients with history of auto-immune disease including history of inflammatory bowel disease
- Patients with active brain metastases
- Patients in the child-bearing ages who refuse to use adequate birth control measures (example: contraceptives, barrier method, or abstinence)
- Lactating females who do not agree to stop breastfeeding
- Known active hepatitis B or C
See the full eligibility criteria
Who can join
- Patients should have a diagnosis of metastatic colon or rectal or breast cancer that is pathology proven
- Patients should have a CEA producing colorectal cancer or breast cancer defined as a baseline CEA or prior documented CEA level exceeding 5 ng/ml or evidence of CEA staining by Immunohistochemistry (IHC)
- Patients should 18 years of age or older
- Patients are willing and capable to consent to study and to adhere with all elements of the study
- Patients who have failed to respond to standard systemic therapy, or for whom standard or curative systemic therapy does not exist, is not tolerable or was refused
- Patients should be at least 4 weeks from last receipt of a cytotoxic or biological agent prior to start of SBRT, with the exception of mitomycin C which requires a 6-week washout
- Patients should have unresectable disease or not be a candidate for surgical resection
- Patients must have a minimum of 1 and a maximum of 5 separate metastatic lesions planned for SBRT. (Patients may have \> 5 metastatic lesions overall, however only up to 5 lesions will be treated with SBRT.) SBRT sites...
- Patients should be at least 4 weeks from last radiation therapy prior to starting SBRT
- Patients should be at least 4 weeks from any investigational therapy prior to starting SBRT, with the exception of prior immunotherapy which would require a 3 month washout
- Patients should have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Patients should be considered clinically stable with an estimated overall survival of at least 3 months
- Neutrophil count \> 1500/mm\^3
- Lymphocyte count \> 500/mm\^3
- Hemoglobin \> 9 gm/dl
- Platelets count \> 100,000/mm\^3
- Aspartate transaminase (AST)/alanine transaminase (ALT) \< 2.5 x upper limit of normal (ULN)
- Bilirubin ≤ ULN
- Patients should have adequate kidney function defined as a serum creatinine \ 60ml/min (Cockroft-Gault formula)
- Patients should have adequate cardiac function defined as:
- No history of acute coronary syndromes (including myocardial infarction, unstable angina, Coronary artery bypass grafting (CABG), coronary angioplasty, or stenting) \< 12 months prior to screening
- No impaired cardiovascular function or clinically significant cardiovascular diseases, including any of the following:
- Symptomatic chronic heart failure;
- Evidence of clinically significant cardiac arrhythmias and/or conduction abnormalities
- No uncontrolled arterial hypertension despite appropriate medical therapy (defined as systolic blood pressure \> 160 or diastolic blood pressure \>100)
- Electrocardiogram (EKG) showing normal sinus rhythm and a corrected QT (QTc) ≤ 450 ms for male and ≤ 470 ms for female patients
- Patients should have adequate pulmonary function defined as:
- Lack of uncontrolled pleural effusion requiring recurrent draining procedures (more than once per month)
- Lack of oxygen supplementation dependence
- All people must have the ability to understand and the willingness to sign a written informed consent
- Screening 2-dimensional (2-D) echocardiogram (echo) shows a left ventricular ejection fraction (LVEF) \> 40%
- Urinalysis shows lack of proteinuria or a maximum of 1+ proteinuria
- Women of childbearing potential should use highly effective contraception while receiving the trial regimen and for at least 5 half-lives of M5A-IL2 from the last dose of M5A-IL2
What rules you out
- Patients on immunosuppressive treatments including supra-physiological doses of corticosteroids
- Patients with history of auto-immune disease including history of inflammatory bowel disease
- Patients with active brain metastases
- Patients in the child-bearing ages who refuse to use adequate birth control measures (example: contraceptives, barrier method, or abstinence)
- Lactating females who do not agree to stop breastfeeding
- Known active hepatitis B or C
- Major surgical procedure within 4 weeks prior to SBRT
- Non-healed wound or surgical incisions
- Radiographic evidence of bowel obstruction
- Electrolyte disturbances (sodium, potassium, magnesium, calcium, and phosphorous) that are not correctable to at least CTCAE grade 1 with replacement therapy
- Known hypersensitivity of any of the study drug agents or components
- Patients should not have any uncontrolled illness including ongoing or active infection
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study agents
- Pregnant women are excluded from this study because the investigational agents on this study are highly likely to exert teratogenic or abortifacient effects
- Patients with other active malignancies are ineligible for this study
- people, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, 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 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?
Study sites include Duarte, 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.