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

Must have received: systemic therapy

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

Cannot have received: radiotherapy to target lesions

Radiotherapy to the target lesions within 4 weeks prior to the first NILK-2301 infusion

Cannot have received: anti-cancer therapy including chemotherapy, hormonal therapy, and investigational agents

Exception: 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

Prior anti-cancer therapy including chemotherapy, hormonal therapy, and investigational agents within 28 days prior to starting NILK-2301 dosing

Cannot have received: other investigational therapies

Exception: COVID-19 vaccination is allowed only starting from Cycle 2 (if not completed before study inclusion)

Other investigational therapies must not be used, i.e., treatment within another clinical trial is not permitted, while the patient is on study

Cannot have received: CEACAM5 targeting agent

Previous treatment with a CEACAM5 targeting agent

Cannot have received: T-cell bispecific antibody

Prior treatment with a T-cell bispecific antibody or CAR T-cells

Cannot have received: CAR-T cell therapy

Prior treatment with a T-cell bispecific antibody or CAR T-cells