BridgeMD
New treatment option for Colorectal Cancer Metastatic
Official title A Study of NILK-2301 in Patients with Locally Advanced or Metastatic Low Tumor Volume (LTV) Colorectal Cancer
ClinicalTrials.gov ID: NCT06663839
What this study is testing
What is Biological NILK-2301?
Biological NILK-2301 is an investigational medicine, being studied as a potential treatment for colorectal cancer metastatic.
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
- Study LCB-2301-001 is an open-label, Phase 1, dose escalation (Part A) and expansion (Part B), first-in-human clinical study of NILK-2301 in patients with locally advanced or metastatic low tumor volume (LTV) colorectal cancer. The dose escalation part (Part A) of the study will evaluate the safety and tolerability of escalating doses of NILK-2301 to determine the maximum tolerated dose (MTD) and non-tolerated toxic dose (NTD) of NILK-2301 monotherapy.
- Phase 1: an early, usually small safety study
- Time commitment: about 12 months
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 at the time of signing the informed consent form (ICF).
- Histologically or cytologically confirmed diagnosis of CRC.
- Patients with locally advanced or metastatic disease
- after at least 1 prior systemic treatment for the primary malignancy
- and who have failed treatment with, are intolerant to, or are not candidates for available therapies that are known to confer a clinical benefit to...
You likely can't join if
- Patient has known hypersensitivity to NILK-2301 or any of the constituent compounds.
- Patients with CNS lesions and / or bone disease.
- Patients with pleural and / or pericardial tumor lesions.
- Radiotherapy to the target lesions within 4 weeks prior to the first NILK- 2301 infusion.
- Prior anti-cancer therapy including chemotherapy, hormonal therapy, and investigational agents within 28 days prior to starting NILK-2301 dosing...
- Other investigational therapies must not be used, i.e., treatment within another clinical trial is not permitted, while the patient is on study...
See the full eligibility criteria
Who can join
- Adults ≥ 18 years of age at the time of signing the informed consent form (ICF).
- Histologically or cytologically confirmed diagnosis of CRC.
- Patients with locally advanced or metastatic disease
- after at least 1 prior systemic treatment for the primary malignancy
- and who have failed treatment with, are intolerant to, or are not candidates for available therapies that are known to confer a clinical benefit to patients with these tumor entities.
- Measurable disease according to the revised RECIST guideline version 1.1 (5).
- Tumor lesions of up to approximately 50 cc estimated with the sum of all measurable lesions (excluding pathological lymph nodes) longest diameter (SLD). SLD should be \< 7 cm.
- Any measurable lesion (excluding pathological lymph nodes) longest diameter ˂ 5 cm.
- Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1.
- people must have the following laboratory values (determined by local lab):
- Absolute neutrophil count (ANC) ≥ 1.0 x 109/L, the use of colony- stimulating factors, i.e., granulocyte colony-stimulating factor (G-CSF) or GM-CSF, within 14 days before the test is not allowed.
- Platelets ≥ 100 x 109/L, transfusion support within 14 days before the test is not allowed.
- Hemoglobin ≥ 10 g/dL. Prior RBC transfusion is permitted.
- Potassium within normal limits or correctable with supplements.
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN), or Alkaline Phosphatase (ALP) ≤ 3 × ULN
- Serum bilirubin \< 1.5 x ULN.
- Calculated glomerular filtration rate of ≥ 45 mL/min/1.73 m2, according to the MDRD abbreviated formula.
- International normalized ratio (INR) \< 1.5 x ULN and partial thromboplastin time (PTT)\< 1.5 x ULN.
- Females of childbearing potential (FCBP) must:
- have two negative urine or serum pregnancy tests as verified by the Investigator prior to starting NILK-2301; the subject may not receive NILK-2301 until the Investigator has verified that the result of the pregnancy...
- agree to use and be able to comply with a highly effective birth control method, i.e., one that can achieve a failure rate of less than 1% per year when used consistently and correctly, from signing the ICF, throughout...
What rules you out
- Patient has known hypersensitivity to NILK-2301 or any of the constituent compounds.
- Patients with CNS lesions and / or bone disease.
- Patients with pleural and / or pericardial tumor lesions.
- Radiotherapy to the target lesions within 4 weeks prior to the first NILK- 2301 infusion.
- Prior anti-cancer therapy including chemotherapy, hormonal therapy, and investigational agents within 28 days prior to starting NILK-2301 dosing. Note: low dose steroids (oral prednisone or equivalent ≤ 10 mg per day...
- Other investigational therapies must not be used, i.e., treatment within another clinical trial is not permitted, while the patient is on study. COVID- 19 vaccination is allowed only starting from Cycle 2 (if not...
- Severe cardiac dysfunction (NYHA classification III-IV).
- Significant hepatic dysfunction (serum bilirubin ≥ 1.8 mg/dL or AST and/or ALT ≥ 2.5 times ULN), or ALP ≤ 3 × ULN.
- Patients with known human immunodeficiency virus (HIV) infection or known history or serological evidence of hepatitis B or C virus infection.
- Uncontrolled active systemic bacterial, viral, fungal, or other infection (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other...
- Confirmed history or current autoimmune disease or other diseases or conditions resulting in permanent immunosuppression or requiring permanent immunosuppressive therapy. Low- dose steroids (oral prednisone or...
- Patients with concomitant active malignancy requiring ongoing systemic treatment.
- Patients with CNS metastases, history of leptomeningeal disease, or seizure disorder requiring therapy (e.g., steroids or anti-epileptics).
- ANC \< 1 x 109/L (the use of colony stimulating factors, G-CSF or GM-CSF, within 14 days before the test is not allowed).
- Pregnancy and lactation.
- History of psychiatric illness or substance abuse likely to interfere with ability to comply with protocol requirements or give informed consent.
- Significant medical diseases or conditions, including laboratory abnormalities, as assessed by the Investigators and Sponsor, that would substantially increase the risk-benefit ratio of participating in the study. This...
- Patients in whom acute toxic effects of any prior radiotherapy, chemotherapy, or surgical procedure have not resolved to Grade ≤ 1 or returned to baseline except for alopecia (any grade), anemia, and peripheral...
- Exposure to live or live attenuated vaccine within 28 days prior to signing the ICF.
- Previous treatment with a CEACAM5 targeting agent.
- Prior treatment with a T-cell bispecific antibody or CAR T-cells.
The study team makes the final eligibility decision.
Where it's taking place
- Barcelona, Spain
- Madrid, Spain
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 12 months 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 Barcelona, Spain; Madrid, Spain. 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.