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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.



Inclusion and Exclusion Criteria

  • Inclusion Criteria:
  • Men and Women > 18 years of age with Eastern Cooperative Oncology Group (ECOG) performance status < 2; 2a. Eligibility: U.S. Sites Includes subjects with loco-regional disease that have relapsed/recurred within 6 months of chemo-radiation and who have no standard of care. Includes patients (subjects) with metastatic disease having injections into only superficial lesions that have failed (includes progression, relapse or intolerance) or not be a candidate for approved therapies. Note, patients (subjects) that have approved therapies available, which might confer clinical benefit, may be enrolled as long as the physician properly explains the nature of the treatment, and obtains consent ". Includes patients (subjects) with metastatic disease having at least one deep tumor injection who have failed (includes progression, relapse or intolerance) all approved lines of therapy prior to enrollment unless they are not an appropriate candidate for a particular approved therapy or no approved therapy exists. Note: There is no limit on the number of prior therapies that a patient (subject) may have received prior to enrollment in any cohort. 2b. Eligibility: Canadian Sites Subjects with advanced or metastatic solid tumors that have disease progression after treatment with approved, available therapies (in site's country) for the cancer type or for whom available therapies have limited benefit and the subject refuses the available therapy. Includes subjects with locoregional disease that have relapsed/recurred within 6 months of chemo-radiation; or who have no standard of care or beneficial options. No limit on the number of prior treatments;
  • Subjects must have measurable disease by RECIST 1.1 criteria including one target tumor for injection. Superficial tumors must have one tumor greater than or equal to 1.0 cm, deep tumors greater than or equal to 1.0 cm (as measured by caliper (for non-injected tumors only) or image guidance);
  • Subjects must have a minimum of one injectable lesion as determined by the investigator (for superficial tumors) or radiologist (deep tumors).
  • Prior chemotherapy or immunotherapy (tumor vaccine, cytokine, or growth factor given to control the cancer: systemic or IT) must have been completed at least 4 weeks prior to enrollment and all adverse events have either returned to baseline (or resolved to < grade 1); note: subjects who have received prior platinum therapy are eligible irrespective of their response.
  • Prior systemic radiation therapy (either IV, intrahepatic or oral) completed at least 4 weeks prior to study drug administration.
  • Prior focal radiotherapy completed at least 4 weeks prior to study drug administration.
  • Prior major treatment-related surgery completed at least 4 weeks prior to study drug administration;
  • No prior primary or metastatic brain or meningeal tumors unless clinically and radiographically stable as well as off steroid therapy for at least 2 months; 10a. Life expectancy ≥8 weeks all (US); 10b. Life expectancy ≥12 weeks; ≥ 8 weeks superficial tumors (Canada);
  • 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
  • Screening laboratory values must meet the following criteria:
  • White Blood Cell (WBC) ≥2000/μL (≥2 x 10^9/L)
  • Neutrophils ≥1000/μL (≥1 x 10^9/L)
  • Platelets ≥70x103/μL (≥ 70 x 10^9/L) (superficial tumor dosing only)
  • Hemoglobin ≥8 g/dL (≥80 g/L) (superficial tumor dosing only)
  • Creatinine within the institution's laboratory upper limit of normal (ULN) or calculated creatinine clearance >50 ml/min
  • alanine aminotransferase /aspartate aminotransferase (ALT/AST) ≤2.5 x ULN without, and ≤ 5 x ULN with hepatic metastases
  • Bilirubin ≤2 x ULN (except subjects with Gilbert's syndrome, who must have total bilirubin < 3.0 mg/dL (<52 µmol/L))
  • For patients with planned deep tumor injections: prothrombin time (PT), activated partial thromboplastin time (aPPT), and international normalized ratio (INR) within normal limits; Platelet count ≥100,000/μL; hemoglobin ≥ 9 gm/dL.
  • Additional criteria for cohort D (anti-PD1 combo) will be supplied in an appendix at a later date. Exclusion Criteria:
  • History of severe hypersensitivity reactions to cisplatin or vinblastine or other products of the same class;
  • Other prior malignancy, except for adequately treated basal or squamous cell skin cancer or superficial bladder cancer, or any other cancer from which the subject has been disease-free for at least 5 years;
  • Underlying medical condition that, in the Principal Investigator's opinion, will make the administration of study drug hazardous or obscure the interpretation of toxicity determination or adverse events;
  • Concurrent medical condition requiring the use of immunosuppressive medications, or systemic or topical corticosteroids; systemic or topical corticosteroids must be discontinued at least 4 weeks prior to enrollment. Inhaled or intranasal corticosteroids (with minimal systemic absorption may be continued if the subject is on a stable dose). Non-absorbed intra-articular steroid injections will be permitted; or use of other investigational drugs (drugs not marketed for any indication) within 30 days prior to study drug administration. Use of steroids as prophylactic treatment for subjects with contrast allergies to diagnostic imaging contrast dyes will be permitted;
  • For deep tumor cohorts, patients who require uninterrupted anticoagulants of any type, on daily aspirin therapy, or NSAIAs.
  • U.S. ONLY: For all Cohorts, patients who refuse approved therapy for which they are a suitable candidate are not eligible for enrollment on this trial.
  • Additional criteria for cohort D (anti-PD1 combo) will be supplied in an appendix at a later date.


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