Metastatic Solid TumorPhase 1/2INJECTABL-1NCT05688280
Intratumoral Injection of IP-001 Following Thermal Ablation in Patients With CRC, NSCLC, and STS
A Phase 1/2 study testing 1.0% IP-001 for Injection in people with Metastatic Solid Tumor and Colon Cancer, run by Immunophotonics, Inc. at 16 sites in 5 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Solid Tumor, Colon Cancer, Nonsmall Cell Lung Cancer
- What is being tested?
- 1.0% IP-001 for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 16 sitesin 5 countries
- Study dates
- 29 Nov 2022to Feb 2025
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
16 sites in 5 countries.
16 sites in 5 countries
France4 sites
Institut Bergonie
Bordeaux, 33076
Hospitalier Pitie-Salpetriere
Paris, 75013
Hôpital Foch
Suresnes, 92150
Institut Gustave Roussy
Villejuif, 94805
Switzerland4 sites
IOSI Ospedale San Giovanni Bellinzona
Bellinzona, 6500
Inselspital Universitatsspital, Bern
Bern, CH-3010
Kantonsspital Graubunden
Chur, 7000
Kantonsspital St. Gallen
Sankt Gallen, CH-9007
United States3 sites
Miami Cardiac & Vascular Institute
Coral Gables, Florida, 33146
University of Louisville Physicians, PSC
Louisville, Kentucky, 40202
Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
Germany3 sites
Johann Wolfgang Goethe-Univresitat Frankfurt/Main
Frankfurt, 60590
SLK-Kliniken Heilbronn GmbH
Heilbronn, 74078
Munchen Klinik Bogenhausen
Munich, 81925
United Kingdom2 sites
University College London Hospitals
London, W1T 7HA
Churchill Hospital
Oxford, OX3 7LJ
About this study
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
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.
Read the 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.
- Being tested
- 1.0% IP-001 for Injection
- Keywords
- 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
- Medical subject headings
- Neoplasm Metastasis, Colonic Neoplasms, Carcinoma, Non-Small-Cell Lung, Sarcoma, Neoplasms, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1.0% IP-001 for InjectionDrug
Also called IP-001
4 mL 1.0% IP-001 for Injection following RFA every 6 weeks for up to 4 treatments.
| Study group | Role | What they receive |
|---|---|---|
| Colorectal Cancer (CRC) | Experimental | Radiofrequency ablation (RFA) followed by an intratumoral injection of IP-001. Receives: Drug: 1.0% IP-001 for Injection |
| Non-Small Cell Lung Cancer (NSCLC) | Experimental | Radiofrequency ablation (RFA) followed by an intratumoral injection of IP-001. Receives: Drug: 1.0% IP-001 for Injection |
| Soft Tissue Sarcoma (STS) | Experimental | Radiofrequency ablation (RFA) followed by an intratumoral injection of IP-001. Receives: Drug: 1.0% IP-001 for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability
The assessment of safety will be based on incidence of adverse events.
Measured: Up to 12 weeks
Secondary outcomes (16)
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.
Measured: Up to 12 weeks
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.
Measured: Up to 12 weeks
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.
Measured: Up to 12 weeks
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.
Measured: Up to 12 weeks
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.
Measured: Up to 12 weeks
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.
Measured: Up to 12 weeks
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.
Measured: Up to 12 weeks
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.
Measured: Up to 12 weeks
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.
Measured: Up to 12 weeks
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.
Measured: Up to 12 weeks
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.
Measured: Up to 12 weeks
Efficacy: Overall survival (OS)
An OS is defined as the time from start of treatment until death from any cause.
Measured: Up to 12 weeks
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.
Measured: Up to 12 weeks
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.
Measured: Up to 12 weeks
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.
Measured: Up to 12 weeks
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.
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study start29 Nov 2022
- Primary completionFeb 2025 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Open-label study with 3 Cohorts * Cohort 1: 18 patients with Stage 3 or Stage 4 Colorectal Cancer (CRC) * Cohort 2: 17 patients with Stage 3 or Stage 4 Non-Small Cell Lung Cancer (NSCLC) * Cohort 3: 3 patients with Stage 3 or Stage 4 Soft Tissue Sarcoma (STS) There will be 3 study periods: a Pretreatment Period, a Treatment Period, and a Follow-up Period.
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Immunophotonics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Markus Jorger, MD, Principal investigator, Cantonal Hospital of St. GallenDiane Beatty, PhD, Study director, Immunophotonics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05688280
- Sponsor's protocol ID
- IP-IIO-622
- Acronym
- INJECTABL-1
- Status last verified
- Jan 2025
- First submitted
- 22 Dec 2022
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05688280
- Acronym / sponsor ID
- INJECTABL-1 / IP-IIO-622
- Keywords
- Cancer, Anti-cancer drug or therapy, Advanced solid tumors, Intratumoral injection, IP-001, Thermal ablation, Phase lb/lla, Melanoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Immunophotonics, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Nov 2022 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 18 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Open-label study with 3 Cohorts * Cohort 1: 18 patients with Stage 3 or Stage 4 Colorectal Cancer (CRC) * Cohort 2: 17 patients with Stage 3 or Stage 4 Non-Small Cell Lung Cancer (NSCLC) * Cohort 3: 3 patients with Stage 3 or Stage 4 Soft Tissue Sarcoma (STS) There will be 3 study periods: a Pretreatment Period, a Treatment Period, and a Follow-up Period.
| Arm | Type | Receives |
|---|---|---|
| Colorectal Cancer (CRC) | Experimental | Drug: 1.0% IP-001 for InjectionRadiofrequency ablation (RFA) followed by an intratumoral injection of IP-001. |
| Non-Small Cell Lung Cancer (NSCLC) | Experimental | Drug: 1.0% IP-001 for InjectionRadiofrequency ablation (RFA) followed by an intratumoral injection of IP-001. |
| Soft Tissue Sarcoma (STS) | Experimental | Drug: 1.0% IP-001 for InjectionRadiofrequency ablation (RFA) followed by an intratumoral injection of IP-001. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1.0% IP-001 for InjectionAlso: IP-0014 mL 1.0% IP-001 for Injection following RFA every 6 weeks for up to 4 treatments. | Drug | Colorectal Cancer (CRC), Non-Small Cell Lung Cancer (NSCLC), Soft Tissue Sarcoma (STS) |
Primary outcome
Safety and Tolerability
Time frame: Up to 12 weeks
The assessment of safety will be based on incidence of adverse events.
16 secondary outcomes
Efficacy: Disease control according to Immune Response Evaluation Criteria in Solid Tumors for immune-based treatment (iRECIST) (iDC)
Time frame: Up to 12 weeks
Efficacy: Disease control according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) (DC)
Time frame: Up to 12 weeks
Efficacy: Objective response according to iRECIST (iOR)
Time frame: Up to 12 weeks
Efficacy: Duration of response according to iRECIST (iDOR)
Time frame: Up to 12 weeks
Efficacy: Progression-free survival according to iRECIST (iPFS)
Time frame: Up to 12 weeks
Efficacy: Objective response according to RECIST 1.1 (OR)
Time frame: Up to 12 weeks
Efficacy: Duration of response according to RECIST 1.1 (DOR)
Time frame: Up to 12 weeks
Efficacy: Progression-free survival according to RECIST 1.1 (PFS)
Time frame: Up to 12 weeks
Efficacy: Time to response according to iRECIST 1.1 (iTTR)
Time frame: Up to 12 weeks
Efficacy: Time to response according to RECIST 1.1 (TTR)
Time frame: Up to 12 weeks
Efficacy: Disease-free survival (DFS)
Time frame: Up to 12 weeks
Efficacy: Overall survival (OS)
Time frame: Up to 12 weeks
Efficacy: OR of the injected lesions according to RECIST 1.1
Time frame: Up to 12 weeks
Efficacy: OR of the non-injected lesions according to RECIST 1.1
Time frame: Up to 12 weeks
Efficacy: iOR of the injected lesions according to iRECIST
Time frame: Up to 12 weeks
Efficacy: iOR of the non-injected lesions according to iRECIST
Time frame: Up to 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Markus Jorger, MD principal investigator
Cantonal Hospital of St. Gallen
Diane Beatty, PhD study director
Immunophotonics, Inc.
16 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 1.0% IP-001 for Injection in people with Metastatic Solid Tumor and Colon Cancer, run by Immunophotonics, Inc. at 16 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in France, Switzerland, United States, Germany, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability (time frame: Up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2025.