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.
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
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.
Single group
Biological NILK-2301
DrugTreatments 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.
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.
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.
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.
Adverse Events (AEs)
Number of patients with AEs as assessed by CTCAE v5.0
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
Overall Survival (OS)
Is defined as the time from the first dose of NILK-2301 to death from any cause
Pharmacokinetics - Cmax
Maximum concentration of drug
Presence of anti-drug antibodies (ADA)
Detection of ADAs in patients
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