RecruitingPhase 1NCT06663839

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

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

Sponsor

Light Chain Bioscience - Novimmune SA

Enrollment

25 participants

Start Date

Apr 12, 2024

Study Type

INTERVENTIONAL

Conditions

Colorectal Cancer Metastatic

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new experimental drug called NILK-2301 — a type of immunotherapy — in people with locally advanced or metastatic colorectal cancer that has a relatively small total amount of tumor spread (called low tumor volume). People with smaller tumor burdens may respond differently to immune-based treatments. **You may be eligible if...** - You are 18 or older - You have colorectal cancer that has spread or cannot be removed surgically - Your cancer has progressed on at least one prior standard treatment - Your total measurable tumor size is small (each individual tumor lesion is under 5 cm, and the sum of all measurable lesions is under 7 cm) - Your general health is good (ECOG score 0 or 1) - Your blood counts and organ function meet required levels **You may NOT be eligible if...** - You have large tumor masses (any single lesion 5 cm or larger) - You have not tried any prior treatment - Your performance status or organ function is below acceptable thresholds - You have active brain metastases or serious other illnesses Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBiological NILK-2301

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.