OncRef

Clinical Trial: NCT06048367

Carbon Nanoparticle-Loaded Iron [CNSI-Fe(II)] in the Treatment of Advanced Solid Tumor

Status:

COMPLETED

Phase:

Phase 1

Lead Sponsor:Sichuan Enray Pharmaceutical Sciences Company
Information Provided By:Sichuan Enray Pharmaceutical Sciences Company
Last Update Posted:2025-08-03

Study Overview

Brief Summary

This Phase I clinical trial aims to evaluate the safety, tolerability, pharmacokinetics (PK) profile and preliminary efficacy of intratumoral injection of Carbon Nanoparticle-Loaded Iron [CNSI-Fe(II)] in patients with advanced solid tumors. The study also aims to observe dose-limiting toxicities (DLT) of CNSI-Fe(II) to determine the maximum tolerated dose (MTD) or the highest injectable dose in humans, providing dosing guidelines for future clinical studies. CNSI-Fe(II) shows promise as an innovative tumor therapeutic agent due to its unique properties of ferroptosis. The study primarily focuses on assessing the potential efficacy of CNSI-Fe(II) in patients with advanced solid tumors, particularly in patients with Kras mutation, e.g., pancreatic cancer patients.

Official Title

Carbon Nanoparticle-Loaded Iron [CNSI-Fe(II)] Dose Escalation Study for the Treatment of Advanced Solid Tumors: Phase 1 Clinical Trial

Conditions

Advanced Solid Tumor, Lung Cancer, Pancreas Cancer, Breast Cancer, Thyroid Cancer, Colorectal Cancer, Cervical Cancer, Ovarian Cancer, Vulva Cancer

Intervention / Treatment

  • Drug: CNSI-Fe(II) 30 mg
  • Drug: CNSI-Fe(II) 60 mg
  • Drug: CNSI-Fe(II) 90 mg
  • Drug: CNSI-Fe(II) 120 mg
  • Drug: CNSI-Fe(II) 150 mg

Other Study ID Numbers

  • CNSI-Fe(II)

Start Date (Actual)

2022-11-17

Primary Completion Date (Actual)

2024-09-29

Study Completion Date (Actual)

2025-02-06

Enrollment (Actual)

19

Study Type

Interventional

Phase

Phase 1