Trial Title:
Intratumoral Injection of IP-001 Following Thermal Ablation in Patients With CRC, NSCLC, and STS
NCT ID:
NCT05688280
Condition:
Metastatic Solid Tumor
Colon Cancer
Nonsmall Cell Lung Cancer
Soft Tissue Sarcoma
Conditions: Official terms:
Lung Neoplasms
Sarcoma
Carcinoma, Non-Small-Cell Lung
Conditions: 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
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Intervention 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.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
1.0% IP-001 for Injection
Description:
4 mL 1.0% IP-001 for Injection following RFA every 6 weeks for up to 4 treatments.
Arm group label:
Colorectal Cancer (CRC)
Arm group label:
Non-Small Cell Lung Cancer (NSCLC)
Arm group label:
Soft Tissue Sarcoma (STS)
Other name:
IP-001
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Miami Cardiac & Vascular Institute
Address:
City:
Coral Gables
Zip:
33146
Country:
United States
Status:
Recruiting
Contact:
Last name:
Govindarajan Narayanan, MD
Email:
govindarajann@baptisthealth.net
Facility:
Name:
University of Louisville Physicians, PSC
Address:
City:
Louisville
Zip:
40202
Country:
United States
Status:
Recruiting
Contact:
Last name:
Robert Martin, PhD, MD
Phone:
502-562-4158
Email:
robert.martin@louisville.edu
Facility:
Name:
Stephenson Cancer Center
Address:
City:
Oklahoma City
Zip:
73104
Country:
United States
Status:
Recruiting
Contact:
Last name:
Abdul R Naqash, MD
Email:
abdulrafeh-naqash@ouhsc.edu
Facility:
Name:
Institut Bergonie
Address:
City:
Bordeaux
Zip:
33076
Country:
France
Status:
Completed
Facility:
Name:
Hospitalier Pitie-Salpetriere
Address:
City:
Paris
Zip:
75013
Country:
France
Status:
Completed
Facility:
Name:
Hôpital Foch
Address:
City:
Suresnes
Zip:
92150
Country:
France
Status:
Completed
Facility:
Name:
Institut Gustave Roussy
Address:
City:
Villejuif
Zip:
94805
Country:
France
Status:
Completed
Facility:
Name:
Johann Wolfgang Goethe-Univresitat Frankfurt/Main
Address:
City:
Frankfurt
Zip:
60590
Country:
Germany
Status:
Completed
Facility:
Name:
SLK-Kliniken Heilbronn GmbH
Address:
City:
Heilbronn
Zip:
74078
Country:
Germany
Status:
Completed
Facility:
Name:
Munchen Klinik Bogenhausen
Address:
City:
Munich
Zip:
81925
Country:
Germany
Status:
Completed
Facility:
Name:
IOSI Ospedale San Giovanni Bellinzona
Address:
City:
Bellinzona
Zip:
6500
Country:
Switzerland
Status:
Recruiting
Contact:
Last name:
Sara DeDosso, MD
Phone:
+41 91 811 86 67
Email:
sara.dedosso@eoc.ch
Contact backup:
Last name:
Ilaria Colombo, MD
Phone:
+41 91 811 81 94
Email:
ilaria.colombo@eoc.ch
Facility:
Name:
Inselspital Universitatsspital, Bern
Address:
City:
Bern
Zip:
CH-3010
Country:
Switzerland
Status:
Active, not recruiting
Facility:
Name:
Kantonsspital Graubunden
Address:
City:
Chur
Zip:
7000
Country:
Switzerland
Status:
Recruiting
Contact:
Last name:
Michael Mark, MD
Phone:
+41 81 256 74 25
Email:
Michael.Mark@ksgr.ch
Contact backup:
Last name:
Sara Bastian, MD
Phone:
+41 81 256 68 84
Email:
sara.bastian@ksgr.ch
Facility:
Name:
Kantonsspital St. Gallen
Address:
City:
St. Gallen
Zip:
CH-9007
Country:
Switzerland
Status:
Recruiting
Contact:
Last name:
Markus Jorger, MD
Phone:
+41 76 559 10 70
Email:
Markus.Joerger@kssg.ch
Contact backup:
Last name:
Dagmar Hess, MD
Phone:
+41 71 494 10 80
Email:
dagmar.hess@kssg.ch
Facility:
Name:
University College London Hospitals
Address:
City:
London
Zip:
W1T 7HA
Country:
United Kingdom
Status:
Completed
Facility:
Name:
Churchill Hospital
Address:
City:
Oxford
Zip:
OX3 7LJ
Country:
United Kingdom
Status:
Completed
Start date:
November 29, 2022
Completion date:
May 2025
Lead sponsor:
Agency:
Immunophotonics, Inc.
Agency class:
Industry
Source:
Immunophotonics, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05688280
