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A Phase 1/2 Safety Study of Intratumorally Dosed INT230-6

Descriptive Information
Brief Title † A Phase 1/2 Safety Study of Intratumorally Dosed INT230-6
Official Title † A Phase 1/2 Safety Study of Intratumorally Administered INT230-6 in Adult Subjects With Advanced Refractory Cancers
Brief Summary This study evaluates the intratumoral administration of escalating doses of a novel, experimental drug, INT230-6. The study is being conducted in patients with several types of refractory cancers including those at the surface of the skin (melanoma, head and neck, lymphoma, breast) and tumors within the body such (pancreatic, colon, liver, lung, etc.). Sponsor also plans to test INT230-6 in combination with anti-PD-1 antibodies.
Detailed Description INT230-6 is comprised of a 3 agents in a fixed ratio - a cell permeation enhancer and two, potent anti-cancer payloads (cisplatin and vinblastine sulfate). The penetration enhancer facilitates dispersion of the two drugs throughout injected tumors and enables increased diffusion into cancer cells. (Nonclinical safety studies showed no findings following drug injection into healthy tissues.) Historically physicians administer the two active drugs comprising INT230-6 by intravenous (IV) infusion to achieve a systemic blood level at the limit of tolerability. The objective is destroy both visible tumors and unseen circulating cancer cells (micro-metastases). Unfortunately, dosing drugs IV delivers only a small amount with a low concentration at the tumor site. This approach especially for late stage cancers is not highly effective and often quite toxic to the patient. Attempts at direct intratumoral injection with chemotherapeutic agents have not shown the ability to treat the injected tumor, non-injected tumors or micro-metastases. This lack of efficacy for local administration is due possibly to poor dispersion and a lack of cell uptake of the agents. Due to the use of the novel cell penetration enhancing agent INT230-6 treatment demonstrates strong efficacy in animals having large tumors. The Sponsor's in vivo, non-clinical data shows that INT230-6 thoroughly saturates and kills injected tumors. In addition, the drug induces an adaptive (T-cell mediated) immune response that attacks not only the injected tumor, but non-injected tumors and unseen micro-metastases. Cured animals become permanently immunized against the type of cancer that INT230-6 eliminates. Clinical trial IT-01 will thus seek to determine the safety and potential efficacy of dosing INT230-6 directly into several different types of cancers. In addition animal studies showed a strong synergy of INT230-6 with immune modulation agents. Thus as part of study IT-01 the Sponsor will seek to understand the safety and efficacy of INT230-6 when administered in combination with immuno-therapeutic agents such as antibodies that target Programmed Cell Death (PD-1 or anti-PD-1) receptors. This study seek to understand whether tumor regression can be achieved and patient outcomes improved.
Study Phase Phase 1/Phase 2
Study Type † Interventional
Study Design †
Primary Outcome Measure † Rate and severity of treatment-emergent adverse events ≥ grade 3 attributed to study drug using the NCI Common Terminology Criteria for Adverse Events (CTCAE v.4.03) (Scale 1 to 5)
Secondary Outcome Measure † Preliminary Efficacy: Control or Regression of Injected Tumors by Measurement of Length, Width and Height (in centimeters) Radio-graphically Using Computer Tomography or Magnetic Resonance Imaging to Calculate Tumor Volumes (cubic centimeters) Over Time.
Condition † Melanoma Head and Neck Cancer Lymphoma Breast Cancer Pancreatic Cancer Liver Cancer Colon Cancer Lung Cancer Glioblastoma
Intervention † DrugINT230-6
Study Arms / Comparison Groups Cohort A INT230-6 injections every 28 days for 5 sessions into only superficial tumors, low starting dose, low concentration per tumor. Cohort B1 INT230-6 injections every 28 days for 5 sessions into superficial or deep tumors, low starting dose, low drug concentration per tumor Cohort B2 INT230-6 injections every 28 days for 5 sessions into superficial or deep tumors, medium starting dose, low drug concentration per tumor Cohort B3 INT230-6 injections every 28 days for 5 sessions into superficial or deep tumors, high starting dose, low drug concentration per tumor Cohort C1 INT230-6 injections every 28 days for 5 sessions into superficial or deep tumors, low starting dose, high drug concentration per tumor Cohort C2 INT230-6 injections every 28 days for 5 sessions into superficial or deep tumors, medium starting dose, high drug concentration per tumor Cohort C3 INT230-6 injections every 28 days for 5 sessions into superficial or deep tumors, high starting dose, high drug concentration per tumor Cohort D INT230-6 injections every 28 days for 5 sessions into superficial or deep tumors, dosing per any B or C cohorts (having acceptable tolerability) with addition of anti-PD-1 antibodies Cohort E INT230-6 injections every 14 days for 5 sessions into superficial or deep tumors treated, dosing per any B, C or D cohorts (having acceptable tolerability) an anti-PD-1 antibody could be added
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Drug
Estimated Enrollment † 60
Start Date † February 9, 2017
Completion Date January 2020
Primary Completion Date July 2018
Eligibility Criteria † Inclusion Criteria: 1. Men and Women > 18 years of age with Eastern Cooperative Oncology Group (ECOG) performance status 12 weeks; 11. Subjects who may become pregnant or who are sexually active with a partner who could become pregnant are to use an effective form of barrier contraception during the study and for at least 60 days for female patients and 180 days for male patients after administration of study drug; and 12. Screening laboratory values must meet the following criteria: 1. White Blood Cell (WBC) ≥2000/μL (≥2 x 10^9/L) 2. Neutrophils ≥1000/μL (≥1 x 10^9/L) 3. Platelets ≥70x103/μL (≥ 70 x 10^9/L) (superficial tumor dosing only) 4. Hemoglobin ≥8 g/dL (≥80 g/L) (superficial tumor dosing only) 5. Creatinine within the institution's laboratory upper limit of normal (ULN) or calculated creatinine clearance >50 ml/min 6. alanine aminotransferase /aspartate aminotransferase (ALT/AST) ≤2.5 x ULN without, and ≤ 5 x ULN with hepatic metastases 7. Bilirubin ≤2 x ULN (except subjects with Gilbert's syndrome, who must have total bilirubin
Gender All
Ages 18 Years - N/A
Accepts Healthy Volunteers No
Contacts †† Kim Rivers, 860-415-9619, krivers@ce3inc.com
Location Countries † Canada
Administrative Information
NCT ID † NCT03058289
Organization ID IT-01
Secondary IDs ††
Responsible Party Sponsor
Study Sponsor † Intensity Therapeutics, Inc.
Collaborators †† University of Southern California
Investigators † Study Director: Ian B. Walters, M.D., Intensity Therapeutics
Information Provided By
Verification Date April 2017
First Received Date † February 10, 2017
Last Updated Date April 10, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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