Intratumoral Injection of IP-001 Following Thermal Ablation in Patients With CRC, NSCLC, and STS (INJECTABL-1)
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ClinicalTrials.gov Identifier: NCT05688280 |
Recruitment Status :
Recruiting
First Posted : January 18, 2023
Last Update Posted : December 5, 2023
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Tracking Information | |||||||||
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First Submitted Date ICMJE | December 22, 2022 | ||||||||
First Posted Date ICMJE | January 18, 2023 | ||||||||
Last Update Posted Date | December 5, 2023 | ||||||||
Actual Study Start Date ICMJE | November 29, 2022 | ||||||||
Estimated Primary Completion Date | May 2024 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Safety and Tolerability [ Time Frame: Up to 12 weeks ] The assessment of safety will be based on incidence of adverse events.
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Intratumoral Injection of IP-001 Following Thermal Ablation in Patients With CRC, NSCLC, and STS | ||||||||
Official Title ICMJE | 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 | ||||||||
Brief 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. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Intervention Model Description: Open-label study with 3 Cohorts
There will be 3 study periods: a Pretreatment Period, a Treatment Period, and a Follow-up Period. Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | 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.
Other Name: IP-001
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
44 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | May 2024 | ||||||||
Estimated Primary Completion Date | May 2024 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | France, Germany, Switzerland, United Kingdom, United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT05688280 | ||||||||
Other Study ID Numbers ICMJE | IP-IIO-622 | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Immunophotonics, Inc. | ||||||||
Original Responsible Party | Same as current | ||||||||
Current Study Sponsor ICMJE | Immunophotonics, Inc. | ||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE |
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PRS Account | Immunophotonics, Inc. | ||||||||
Verification Date | December 2023 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |