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Colorectal Cancer MetastaticPhase 1NCT06663839

A Study of NILK-2301 in Patients with Locally Advanced or Metastatic Low Tumor Volume (LTV) Colorectal Cancer

A Phase 1 study testing Biological NILK-2301 in people with Colorectal Cancer Metastatic, run by Light Chain Bioscience - Novimmune SA at 2 sites in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer Metastatic
What is being tested?
Biological NILK-2301
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
2 sitesSpain
Study dates
12 Apr 2024to Jan 2026
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to 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).
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  • 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.
  • Subjects 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 test is negative. A urine or serum pregnancy test is required at screening and within 72 hours prior to dosing on Cycle 1, Day 1, and within 72 hours prior to Day 1 of every subsequent cycle. Note: the Cycle 1, Day 1 pregnancy test does not need to be repeated if the screening pregnancy test was done within 72 hours prior to dosing. A serum or urine pregnancy test (Investigator's discretion) must also be performed at the end of study for each FCBP; and
  • 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 the study, and for up to 28 days following the last dose of NILK-2301

Who cannot join

  • 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, including systemic or topic use), localized non-central nervous system (CNS) radiotherapy of non-target lesions, and treatment with bisphosphonates and RANKL inhibitors are not criteria for exclusion.
  • 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 completed before study inclusion).
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  • 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 treatment), or intravenous anti-infective treatment within 2 weeks prior to first dose of NILK-2301.
  • 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 equivalent ≤ 10 mg per day) for rheumatoid arthritis or similar conditions are allowed.
  • 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 includes, but is not limited to, myocardial infarction within the last 6 months, unstable angina or unstable life-threatening arrhythmias, uncontrolled diabetes mellitus, severely immunocompromised state, and major surgery ≤ 4 weeks prior to starting NILK-2301.
  • 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 neuropathy (for the latter, recovery to Grade ≤ 2 is acceptable).
  • 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.

Trial locations and contacts

2 sites in 1 country.

Clinical Project Manager contact

+41 79 26 83 513

LCB-Clinical@lightchainbio.com

Spain2 sites, 2 recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona

    Recruiting

  • START Madrid-FJD, Hospital Fundación Jiménez Díaz

    Madrid

    Recruiting

Other trials in Spain

About this study

Official title: A Phase I, Open-label, Dose Finding Study of NILK-2301, a Bispecific CEACAM5 X CD3 Engaging Antibody, in Patients with Locally Advanced or Metastatic Low Tumor Volume (LTV) Colorectal Cancer

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. The expansion part (Part B) will further evaluate the safety and efficacy of NILK-2301 monotherapy administered at or below the MTD in up to 10 additional subjects in order to determine the recommended Phase 2 dose (RP2D).

Treatments will be administered every two weeks in 28-day cycles for up to 12 months until disease progression, unacceptable toxicity, or Investigator/patient decision to withdraw study consent.

Being tested
Biological NILK-2301
Keywords
Colorectal Cancer
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biological NILK-2301Drug

    Treatments will be administered every two weeks in 28-day cycles for up to 12 months until disease progression, unacceptable toxicity, or Investigator/patient decision to withdraw study consent. Should evidence emerge showing that treatment beyond one year may prolong benefit in responding patients, the protocol will be amended to ensure that these responding patients may continue with the study treatment beyond 12 months until disease progression.

Study groups in NCT06663839
Study groupRoleWhat they receive
NILK-2301 Single AgentExperimentalNILK-2301 will be evaluated in patients with locally advanced or metastatic low tumor volume colorectal cancer
Receives: Drug: Biological NILK-2301

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose Limiting Toxicity (DLT)

    Is defined as any of the toxicities occurring within the DLT window (Cycle 1, Days 1 to 28) except those that are clearly and incontrovertibly due to extraneous causes.

    Measured: Up to 12 months

  2. Non-Tolerated Dose (NTD)

    Is defined as a dose level at which 2 or more of up to 6 evaluable patients in a cohort experience a DLT in the 4-week DLT window.

    Measured: Up to 12 months

  3. Maximum Tolerated Dose (MTD)

    Is defined as the last cohort below the NTD with 0 or 1 out of 6 evaluable subjects experiencing a DLT during the 4-week DLT window.

    Measured: Up to 12 months

  4. Adverse Events (AEs)

    Number of patients with AEs as assessed by CTCAE v5.0

    Measured: Up to 12 months

Secondary outcomes (4)

  1. Progression Free Survival (PFS)

    Is defined as the time from the first dose of NILK-2301 to progressive disease or death from any cause, whichever occurs first

    Measured: Up to 12 months

  2. Overall Survival (OS)

    Is defined as the time from the first dose of NILK-2301 to death from any cause

    Measured: Up to 12 months

  3. Pharmacokinetics - Cmax

    Maximum concentration of drug

    Measured: Up to 12 months

  4. Presence of anti-drug antibodies (ADA)

    Detection of ADAs in patients

    Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2024
  2. Study start12 Apr 2024
  3. Primary completionOct 2025 (estimated)
  4. Study completionJan 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06663839
Sponsor's protocol ID
LCB-2301-001
Other IDs
2023-508058-24-01, 2023
Status last verified
Oct 2024
First submitted
25 Oct 2024
Last updated
29 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Biological NILK-2301 in people with Colorectal Cancer Metastatic, run by Light Chain Bioscience - Novimmune SA at 2 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Clinical Project Manager (+41 79 26 83 513, LCB-Clinical@lightchainbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose Limiting Toxicity (DLT) (time frame: Up to 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06663839.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2024.

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