NCT06663839

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Light Chain Bioscience - Novimmune SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Biological 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.

Timeline

• Start date: 2024-04-12
• Primary completion: 2025-10-01
• Completion: 2026-01-01
• First posted: 2024-10-29
• Last updated: 2024-10-29

Locations

2 sites across 1 country: Spain