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

NCT06663839 | Recruiting Phase 1

• 2 other identifiers: LCB-2301-0012023-508058-24-01
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Colorectal Cancer Metastatic

Keywords

Colorectal Cancer

Outcome Measures

Primary Outcomes (4)

• 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.

  Up to 12 months

• 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.

  Up to 12 months

• 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.

  Up to 12 months

• Adverse Events (AEs)

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

  Up to 12 months

Secondary Outcomes (4)

• Progression Free Survival (PFS)

  Up to 12 months

• Overall Survival (OS)

  Up to 12 months

• Pharmacokinetics - Cmax

  Up to 12 months

• Presence of anti-drug antibodies (ADA)

  Up to 12 months

Study Arms (1)

NILK-2301 Single Agent

EXPERIMENTAL

NILK-2301 will be evaluated in patients with locally advanced or metastatic low tumor volume colorectal cancer

Drug: Biological NILK-2301

Interventions

Biological NILK-2301 DRUG

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.

NILK-2301 Single Agent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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.
• 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

You may not qualify 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.
• 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.

Sponsors & Collaborators

• Light Chain Bioscience - Novimmune SA: lead

Study Sites (2)

Hospital Universitari Vall d'Hebron

Barcelona, Spain

RECRUITING

START Madrid-FJD, Hospital Fundación Jiménez Díaz

Madrid, Spain

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Clinical Project Manager

CONTACT

+41 79 26 83 513; LCB-Clinical@lightchainbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2024
• First Posted: October 29, 2024
• Study Start: April 12, 2024
• Primary Completion: October 1, 2025
• Study Completion: January 1, 2026
• Last Updated: October 29, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)