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 |
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Recruitment Status :
Recruiting
First Posted : January 18, 2023
Last Update Posted : December 5, 2023
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Sponsor:
Immunophotonics, Inc.
Information provided by (Responsible Party):
Immunophotonics, Inc.
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Metastatic Solid Tumor Colon Cancer Nonsmall Cell Lung Cancer Soft Tissue Sarcoma | Drug: 1.0% IP-001 for Injection | Phase 1 Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 44 participants |
| 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. |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | 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 |
| Actual Study Start Date : | November 29, 2022 |
| Estimated Primary Completion Date : | May 2024 |
| Estimated Study Completion Date : | May 2024 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Lung cancer
MedlinePlus related topics:
Soft Tissue Sarcoma
| Arm | Intervention/treatment |
|---|---|
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Experimental: Colorectal Cancer (CRC)
Radiofrequency ablation (RFA) followed by an intratumoral injection of IP-001.
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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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Experimental: Non-Small Cell Lung Cancer (NSCLC)
Radiofrequency ablation (RFA) followed by an intratumoral injection of IP-001.
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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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Experimental: Soft Tissue Sarcoma (STS)
Radiofrequency ablation (RFA) followed by an intratumoral injection of IP-001.
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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 |
Primary Outcome Measures :
- Safety and Tolerability [ Time Frame: Up to 12 weeks ]The assessment of safety will be based on incidence of adverse events.
Secondary Outcome Measures :
- Efficacy: Disease control according to Immune Response Evaluation Criteria in Solid Tumors for immune-based treatment (iRECIST) (iDC) [ Time Frame: Up to 12 weeks ]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.
- Efficacy: Disease control according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) (DC) [ Time Frame: Up to 12 weeks ]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.
- Efficacy: Objective response according to iRECIST (iOR) [ Time Frame: Up to 12 weeks ]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.
- Efficacy: Duration of response according to iRECIST (iDOR) [ Time Frame: Up to 12 weeks ]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.
- Efficacy: Progression-free survival according to iRECIST (iPFS) [ Time Frame: Up to 12 weeks ]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.
- Efficacy: Objective response according to RECIST 1.1 (OR) [ Time Frame: Up to 12 weeks ]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.
- Efficacy: Duration of response according to RECIST 1.1 (DOR) [ Time Frame: Up to 12 weeks ]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.
- Efficacy: Progression-free survival according to RECIST 1.1 (PFS) [ Time Frame: Up to 12 weeks ]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.
- Efficacy: Time to response according to iRECIST 1.1 (iTTR) [ Time Frame: Up to 12 weeks ]An iTTR is defined as the time from start of trial treatment until iOR according to iRECIST achieved during the trial.
- Efficacy: Time to response according to RECIST 1.1 (TTR) [ Time Frame: Up to 12 weeks ]A TTR is defined as the time from treatment start until OR according to iRECIST achieved during the trial.
- Efficacy: Disease-free survival (DFS) [ Time Frame: Up to 12 weeks ]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.
- Efficacy: Overall survival (OS) [ Time Frame: Up to 12 weeks ]An OS is defined as the time from start of treatment until death from any cause.
- Efficacy: OR of the injected lesions according to RECIST 1.1 [ Time Frame: Up to 12 weeks ]An OR of the ablated and injected (treated) lesions will be assessed using RECIST 1.1.
- Efficacy: OR of the non-injected lesions according to RECIST 1.1 [ Time Frame: Up to 12 weeks ]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.
- Efficacy: iOR of the injected lesions according to iRECIST [ Time Frame: Up to 12 weeks ]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.
- Efficacy: iOR of the non-injected lesions according to iRECIST [ Time Frame: Up to 12 weeks ]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.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
- Life expectancy of > 6 months. Only have lesions with the longest diameter of ≤ 5 cm.
- Presence of at least one non-bone tumor lesion that is ablation-accessible, with a minimum size of 1.0 cm.
- Measurable disease according to RECIST 1.1.
- Age ≥ 18 years.
- ECOG performance status 0-1.
- Bone marrow function: neutrophil count ≥ 1.5 × 109/L, platelet count ≥ 100 × 109/L, hemoglobin ≥ 90 g/L.
- 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).
- 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.
- Adequate renal function defined by an estimated creatinine clearance ≥ 50 mL/min according to the Cockcroft-Gault formula (or local institutional standard method).
- 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:
- Known allergic reaction to shellfish, crabs, crustaceans, or any trial components, used in trial treatment.
- Malignant primary brain tumors or evidence of brain metastases or leptomeningeal disease.
- Patients who have received chemotherapy, radiotherapy, immunotherapy, or concurrent or recent treatment with any other investigational agents within 21 days prior to treatment.
- 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.
- Patients with a history of malignancy, with the exception of non-melanoma skin cancers and in situ cancers.
- Concomitant treatment with systemic corticosteroids (10 mg prednisolone or equivalent) or other immunosuppressive therapy.
- Anti-coagulation therapies which cannot be stopped 24 hours prior to trial treatment.
- Severe or uncontrolled cardiovascular disease (congestive heart failure New York Heart Association classification III or IV).
- Documented HIV positive.
- Active Hepatitis C or Hepatitis B Viral infection.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05688280
Contacts
| Contact: Jane Bierman | +31 64 523 4949 | jane.bierman2@iqvia.com | |
| Contact: Sara Mcloud Tyley | +44 7342 061 439 | sara.mcloudtyley@iqvia.com |
Locations
| United States, Florida | |
| Miami Cardiac & Vascular Institute | Recruiting |
| Coral Gables, Florida, United States, 33146 | |
| Contact: Govindarajan Narayanan, MD govindarajann@baptisthealth.net | |
| United States, Kentucky | |
| University of Louisville Physicians, PSC | Recruiting |
| Louisville, Kentucky, United States, 40202 | |
| Contact: Robert Martin, PhD, MD 502-562-4158 robert.martin@louisville.edu | |
| United States, Oklahoma | |
| Stephenson Cancer Center | Recruiting |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Contact: Abdul R Naqash, MD abdulrafeh-naqash@ouhsc.edu | |
| France | |
| Institut Bergonie | Recruiting |
| Bordeaux, France, 33076 | |
| Contact: Antoine Italiano, MD +33 5 56 33 32 44 a.italiano@bordeaux.unicancer.fr | |
| Hospitalier Pitie-Salpetriere | Recruiting |
| Paris, France, 75013 | |
| Contact: Jean-Philippe Spano, MD +33 1 42 16 04 72 jean-philippe.spano@aphp.fr | |
| Hôpital Foch | Recruiting |
| Suresnes, France, 92150 | |
| Contact: Jaafar Bennouna, MD +33 1 46 25 19 75 j.bennouna@hopital-foch.com | |
| Institut Gustave Roussy | Recruiting |
| Villejuif, France, 94805 | |
| Contact: Thierry de Baere, MD +33 1 42 11 54 28 thierry.debaere@gustaveroussy.fr | |
| Germany | |
| Johann Wolfgang Goethe-Univresitat Frankfurt/Main | Recruiting |
| Frankfurt, Germany, 60590 | |
| Contact: Thomas Vogl t.vogl@em.uni-frankfurt.de | |
| SLK-Kliniken Heilbronn GmbH | Recruiting |
| Heilbronn, Germany, 74078 | |
| Contact: Uwe Martens +49-7131-49-28001 uwe.martens@skl-kliniken.de | |
| Munchen Klinik Bogenhausen | Recruiting |
| Munich, Germany, 81925 | |
| Contact: Thomas Helmberger 00498992702201 thomas.helmberger@muenchen-klinik.de | |
| Switzerland | |
| IOSI Ospedale San Giovanni Bellinzona | Recruiting |
| Bellinzona, Switzerland, 6500 | |
| Contact: Sara DeDosso, MD +41 91 811 86 67 sara.dedosso@eoc.ch | |
| Contact: Ilaria Colombo, MD +41 91 811 81 94 ilaria.colombo@eoc.ch | |
| Inselspital Universitatsspital, Bern | Recruiting |
| Bern, Switzerland, CH-3010 | |
| Contact: Attila Kollar, MD +41 31 632 41 14 attila.kollar@insel.ch | |
| Contact: Sabine Schmid, MD 0041 31 632 41 14 sabine.schmid@insel.ch | |
| Kantonsspital Graubunden | Recruiting |
| Chur, Switzerland, 7000 | |
| Contact: Michael Mark, MD +41 81 256 74 25 Michael.Mark@ksgr.ch | |
| Contact: Sara Bastian, MD +41 81 256 68 84 sara.bastian@ksgr.ch | |
| Kantonsspital St. Gallen | Recruiting |
| St. Gallen, Switzerland, CH-9007 | |
| Contact: Markus Jorger, MD +41 76 559 10 70 Markus.Joerger@kssg.ch | |
| Contact: Dagmar Hess, MD +41 71 494 10 80 dagmar.hess@kssg.ch | |
| United Kingdom | |
| University College London Hospitals | Recruiting |
| London, United Kingdom, W1T 7HA | |
| Contact: Steve Bandula, MD s.bandula@ucl.ac.uk | |
| Churchill Hospital | Recruiting |
| Oxford, United Kingdom, OX3 7LJ | |
| Contact: Mark Middleton, MD | |
Sponsors and Collaborators
Immunophotonics, Inc.
Investigators
| Principal Investigator: | Markus Jorger, MD | Cantonal Hospital of St. Gallen | |
| Study Director: | Diane Beatty, PhD | Immunophotonics, Inc. |
| Responsible Party: | Immunophotonics, Inc. |
| ClinicalTrials.gov Identifier: | NCT05688280 |
| Other Study ID Numbers: |
IP-IIO-622 |
| First Posted: | January 18, 2023 Key Record Dates |
| Last Update Posted: | December 5, 2023 |
| Last Verified: | December 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Immunophotonics, Inc.:
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Cancer Anti-cancer drug or therapy Advanced solid tumors Intratumoral injection IP-001 Thermal ablation Phase lb/lla Melanoma |
Soft tissue sarcoma Tumor ablation Systemic immune response Interventional immuno-oncology Interventional oncology Abscopal effect T-cell stimulation |
Additional relevant MeSH terms:
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Lung Neoplasms Sarcoma Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms |
Lung Diseases Respiratory Tract Diseases Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Carcinoma, Bronchogenic Bronchial Neoplasms |