A Study of NILK-2301 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 1

Trial Details

NCT ID
NCT06663839
Phase
PHASE1
Sponsor
Light Chain Bioscience - Novimmune SA
Status
RECRUITING
Cancer Type
Colorectal Cancer
Interventions
  • Biological NILK-2301
Locations (sample)
  • Barcelona, Spain|41.38879,2.15899
  • Madrid, Spain|40.4165,-3.70256

Key Eligibility Criteria

  • 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

For full eligibility, visit ClinicalTrials.gov.

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