NCT05688280

Intratumoral Injection of IP-001 Following Thermal Ablation in Patients With CRC, NSCLC, and STS

Intratumoral Injection of IP-001 Following Thermal Ablation in Patients With Advanced Solid Tumors. A Multicenter Phase 1b/2a Trial in Colorectal Cancer, Non-small Cell Lung Cancer, and Soft Tissue Sarcoma Patients

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Immunophotonics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to determine the safety and efficacy of IP-001 for intratumoral injection administration following thermal ablation of a solid tumor.

Detailed description

The therapeutic approach taken by this clinical trial may offer patients a therapeutic benefit after failure of standard chemotherapy and immunotherapy. Patients giving written informed consent will undergo screening during the Pretreatment Period to determine eligibility for trial entry. The Pretreatment Period will include collection and recording of medical history, concomitant medications, baseline symptoms, previous therapies, and baseline assessments. The patient's baseline tumor burden will be recorded with radiological assessments, along with analyzing location and size of tumors to identify and characterize target tumor(s) that will be treated and/or followed during the clinical trial. If confirmed eligible for the study, the patient will advance into the Treatment Period. During the Treatment Period, patients will receive a routine radiofrequency ablation (RFA), followed by an injection of investigational product (IP-001 for Injection) into the tumor. Patients can be treated every 6 weeks for up to 4 treatments with RFA + IP-001 for Injection. A patient will move to the 6-month Follow-up Period when the patient has completed 4 treatment cycles or if the decision is made that no subsequent treatments will be administered. During the Follow-up Period, there will be a Follow-up Visit every 6 weeks for 5 visits, at disease progression, or prior to the start of a new antineoplastic treatment.

Conditions

• Metastatic Solid Tumor
• Colon Cancer
• Nonsmall Cell Lung Cancer
• Soft Tissue Sarcoma

Interventions

Type	Name	Description
DRUG	1.0% IP-001 for Injection	4 mL 1.0% IP-001 for Injection following RFA every 6 weeks for up to 4 treatments.

Timeline

• Start date: 2022-11-29
• Primary completion: 2025-02-01
• Completion: 2025-02-01
• First posted: 2023-01-18
• Last updated: 2025-01-08

Locations

16 sites across 5 countries: United States, France, Germany, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study