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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05688280
Other study ID # IP-IIO-622
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date November 29, 2022
Est. completion date May 2024

Study information

Verified date December 2023
Source Immunophotonics, Inc.
Contact Jane Bierman
Phone +31 64 523 4949
Email jane.bierman2@iqvia.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 44
Est. completion date May 2024
Est. primary completion date May 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Stage 3 or Stage 4 CRC, NSCLC, or STS who have failed, are ineligible, refused, or become intolerant to at least first line (but no more than 4 lines) of systemic therapy 2. Life expectancy of > 6 months. Only have lesions with the longest diameter of = 5 cm. 3. Presence of at least one non-bone tumor lesion that is ablation-accessible, with a minimum size of 1.0 cm. 4. Measurable disease according to RECIST 1.1. 5. Age = 18 years. 6. ECOG performance status 0-1. 7. Bone marrow function: neutrophil count = 1.5 × 109/L, platelet count = 100 × 109/L, hemoglobin = 90 g/L. 8. Adequate hematological function defined by white blood cell count = 2.5 × 109/L with absolute neutrophil count = 1.5 × 109/L, and hemoglobin = 9 g/dL (transfusions allowed on study). 9. Adequate hepatic function defined by a total bilirubin level = 1.5 × the upper limit of normal (ULN) range and aspartate transaminase (AST) and alanine aminotransferase (ALT) levels = 2.5 × ULN for all patients, or for patients with documented metastatic disease to the liver and AST and ALT levels = 5 × ULN. Patients with documented Gilbert disease are allowed if total bilirubin is less than 3 × ULN. 10. Adequate renal function defined by an estimated creatinine clearance = 50 mL/min according to the Cockcroft-Gault formula (or local institutional standard method). 11. Men and women with childbearing potential agree to use effective contraception. Women of childbearing potential must have a negative pregnancy test (serum) before inclusion. Exclusion Criteria: 1. Known allergic reaction to shellfish, crabs, crustaceans, or any trial components, used in trial treatment. 2. Malignant primary brain tumors or evidence of brain metastases or leptomeningeal disease. 3. Patients who have received chemotherapy, radiotherapy, immunotherapy, or concurrent or recent treatment with any other investigational agents within 21 days prior to treatment. 4. Patients who have not recovered to common terminology criteria for adverse events (CTCAE) Grade = 1 from all side effects of prior therapies except for residual toxicities. 5. Patients with a history of malignancy, with the exception of non-melanoma skin cancers and in situ cancers. 6. Concomitant treatment with systemic corticosteroids (10 mg prednisolone or equivalent) or other immunosuppressive therapy. 7. Anti-coagulation therapies which cannot be stopped 24 hours prior to trial treatment. 8. Severe or uncontrolled cardiovascular disease (congestive heart failure New York Heart Association classification III or IV). 9. Documented HIV positive. 10. Active Hepatitis C or Hepatitis B Viral infection.

Study Design


Intervention

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.

Locations

Country Name City State
France Institut Bergonie Bordeaux
France Hospitalier Pitie-Salpetriere Paris
France Hôpital Foch Suresnes
France Institut Gustave Roussy Villejuif
Germany Johann Wolfgang Goethe-Univresitat Frankfurt/Main Frankfurt
Germany SLK-Kliniken Heilbronn GmbH Heilbronn
Germany Munchen Klinik Bogenhausen Munich
Switzerland IOSI Ospedale San Giovanni Bellinzona Bellinzona
Switzerland Inselspital Universitatsspital, Bern Bern
Switzerland Kantonsspital Graubunden Chur
Switzerland Kantonsspital St. Gallen St. Gallen
United Kingdom University College London Hospitals London
United Kingdom Churchill Hospital Oxford
United States Miami Cardiac & Vascular Institute Coral Gables Florida
United States University of Louisville Physicians, PSC Louisville Kentucky
United States Stephenson Cancer Center Oklahoma City Oklahoma

Sponsors (1)

Lead Sponsor Collaborator
Immunophotonics, Inc.

Countries where clinical trial is conducted

United States,  France,  Germany,  Switzerland,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety and Tolerability The assessment of safety will be based on incidence of adverse events. Up to 12 weeks
Secondary Efficacy: Disease control according to Immune Response Evaluation Criteria in Solid Tumors for immune-based treatment (iRECIST) (iDC) An iDC is defined as any complete response (CR or iCR), partial response (PR or iPR), or stable disease (SD or iSD) for 12 weeks according to iRECIST achieved during the trial until disease progression according to iRECIST, death from any cause, or start of a subsequent anticancer treatment, whichever occurs first. Up to 12 weeks
Secondary Efficacy: Disease control according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) (DC) A DC is defined as any complete response (CR), partial response (PR) or stable disease (SD) for 12 weeks from start of treatment according to RECIST 1.1 achieved during trial until disease progression according to iRECEST, death from any cause, or start of a subsequent anticancer treatment, whichever occurs first. Up to 12 weeks
Secondary Efficacy: Objective response according to iRECIST (iOR) An iOR is defined as any complete response (CR or iCR) or partial response (PR or iPR) according to iRECIST achieved during the trial until disease progression according to iRECIST, death from any cause, or start of a subsequent anticancer treatment, whichever occurs first. Up to 12 weeks
Secondary Efficacy: Duration of response according to iRECIST (iDOR) An iDOR is defined as the time from the first documentation of iOR until disease progression according to iRECIST (iPD) or death from any cause. iPD is defined as the time point of first iUPD without subsequent iSD, iPR or iCR before trial discontinuation. Up to 12 weeks
Secondary Efficacy: Progression-free survival according to iRECIST (iPFS) An iPFS is defined as the time from treatment start until disease progression according to iRECIST (iPD) or death from any cause, whichever occurs first. Up to 12 weeks
Secondary Efficacy: Objective response according to RECIST 1.1 (OR) An OR is defined as any complete response (CR) or partial response (PR) according to RECIST 1.1 achieved during trial until disease progression, death from any cause, or start of a subsequent anticancer treatment, whichever occurs first. Up to 12 weeks
Secondary Efficacy: Duration of response according to RECIST 1.1 (DOR) A DOR is defined as the time from the first documentation of OR until disease progression according to RECIST 1.1, death from any cause, or start of a subsequent anticancer treatment, whichever occurs first. Up to 12 weeks
Secondary Efficacy: Progression-free survival according to RECIST 1.1 (PFS) A PFS is defined as the time from treatment start until disease progression according to RECIST 1.1, or death from any cause, whichever occurs first. Up to 12 weeks
Secondary Efficacy: Time to response according to iRECIST 1.1 (iTTR) An iTTR is defined as the time from start of trial treatment until iOR according to iRECIST achieved during the trial. Up to 12 weeks
Secondary Efficacy: Time to response according to RECIST 1.1 (TTR) A TTR is defined as the time from treatment start until OR according to iRECIST achieved during the trial. Up to 12 weeks
Secondary Efficacy: Disease-free survival (DFS) A DFS is defined as the time from start of treatment that the patient survives without any signs or symptoms of cancer or death from any cause, whichever occurs first. Up to 12 weeks
Secondary Efficacy: Overall survival (OS) An OS is defined as the time from start of treatment until death from any cause. Up to 12 weeks
Secondary Efficacy: OR of the injected lesions according to RECIST 1.1 An OR of the ablated and injected (treated) lesions will be assessed using RECIST 1.1. Up to 12 weeks
Secondary Efficacy: OR of the non-injected lesions according to RECIST 1.1 An OR of the non-ablated and non-injected (untreated) lesions will be assessed using the RECIST 1.1 until disease progression according to RECIST 1.1, death from any cause, or start of a subsequent anticancer treatment, whichever occurs first. Up to 12 weeks
Secondary Efficacy: iOR of the injected lesions according to iRECIST An iOR of the ablated and injected (treated) lesions will be assessed using the iRECIST until disease progression according to RECIST 1.1, death from any cause, or start of a subsequent anticancer treatment, whichever occurs first. Up to 12 weeks
Secondary Efficacy: iOR of the non-injected lesions according to iRECIST An iOR of the non-ablated and non-injected (untreated) lesions will be assessed using the iRECIST until disease progression according to RECIST 1.1, death from any cause, or start of a subsequent anticancer treatment, whichever occurs first. Up to 12 weeks
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