A First-in-Human Study to Evaluate the Administration of ReoCure alone and in combination with Keytruda (Pembrolizumab) in Patients with Advanced Malignant Solid Tumours
- Conditions
- Advanced Malignant Solid TumoursCancer - Any cancer
- Registration Number
- ACTRN12620000777998
- Lead Sponsor
- ViroCure, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 45
A patient will be eligible for study participation if all the following criteria are met:
1. Willing to sign ICF on a voluntary basis and to voluntarily participate in the study, after being fully informed of and completely understanding this study, prior to any Screening procedure being undertaken.
2. Males and females, of any race, aged greater than or equal to 18 years at time of signing the ICF.
3. Patients with histologically or cytologically confirmed advanced/late stage solid tumours:
• of any type, for patients in Phase1a Part A:
• classified as melanoma, gastric adenocarcinoma or gastro-oesophageal junction adenocarcinoma or gastrointestinal stromal tumours or solid tumours of colon or lung, for participants in Phase 1a Part B and in Phase 1b, with hepatic and/or subcutaneous metastases, who failed to respond to existing standard chemotherapies or have refused standard treatment or have condition for which no standard therapy exists.
Patients must have at least one of the below lesions that are accessible (palpable or can be visualized by ultrasound) and amenable to multiple intratumoral injections of ReoCure:
a. Measurable Hepatic lesion as per RECIST 1.1
b. Measurable Subcutaneous lesion as per RECIST 1.1.
4. Patients must have Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2.
5. Patients must have a life expectancy of greater than or equal to 12 weeks.
6. Patients who have adequate haematologic, renal, and hepatic functions as confirmed by the following criteria;
a. ANC greater than or equal to 1,500/µL
b. Platelet greater than or equal to 100,000/µL
c. Hb greater than or equal to 9.0 mg/dL
d. Serum creatinine less than or equal to 1.5 × ULN or eGFR greater than or equal to 45 mL/min/1.73 m2, for patients with creatinine levels above institutional normal
e. Total bilirubin: less than or equal to 1.5 × ULN
f. AST and ALT: less than or equal to 5 × ULN
g. Prothrombin time and aPTT must be normal or in case of borderline elevation must be deemed clinically not significant as ascertained by the Investigator
h. Non-clinically-significant hypoalbuminemia as ascertained by the Investigator is acceptable, provided that there is no:
• Ascites
• Hepatic encephalopathy
7. Patients must have had an interval of greater than or equal to 21 days since exposure to cytotoxic drugs, greater than or equal to 28 days or greater than or equal to 5 half-lives whichever is shorter since exposure to targeted agents (small molecule inhibitors), greater than or equal to 28 days since biological therapy (immunotherapy), hormone therapy and gene therapy, or greater than or equal to 14 days since radiotherapy, at baseline:
a. Patients must have fully recovered to NCI-CTCAE Grade 1 or better from AEs due to all previous cancer therapeutics prior to entering this study.
Note: Patients with less than or equal to Grade 2 neuropathy or less than or equal to Grade 2 alopecia or Grade 2 AEs that qualify as Grade 2 due to replacement hormonal or steroid therapy may qualify for the study with approval by Sponsor/ medical monitor.
b. If a patient received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to enrolment.
c. Patients must have received their last dose of known myelosuppressive anti-cancer chemotherapy at least 3 weeks prior to administration of first dose of IP or at least 6 weeks if nitrosourea.
d. For radiation therapy
A patient will be ineligible for study participation if any of the following criteria are met:
1. Patients with severe hypersensitivity or a history of any hypersensitivity to the similar drug class of the study drugs (IP and Pembrolizumab).
2. Patients with tumour lesions situated in a previously irradiated area, or in an area subjected to other loco-regional therapy, unless there is demonstrated progression in the lesion as per the Investigator’s assessment.
3. Patients with tumour lesions with macroscopic intravascular tumour invasion (e.g. liver lesions with tumour infiltration into the main portal vein, hepatic vein or vena cava).
4. Patients with any of the following medical histories or surgery/procedure histories:
a. Major surgery requiring general anaesthesia or a respiratory assistance device within 4 weeks prior to baseline (within 2 weeks for video-assisted thoracoscopic surgery or open-and-closed surgery)
b. Severe cardiovascular disease within 24 weeks prior to baseline
c. Severe cerebrovascular disease within 24 weeks prior to baseline
d. Pulmonary thromboembolism, deep vein thrombosis (DVT) or other clinically significantly severe lung disease within 24 weeks prior to baseline
e. History of organ transplant that requires use of immunosuppressive medications
5. Patients who have any of the following concomitant diseases at baseline:
a. History of malignancies other than melanoma, gastric adenocarcinoma or gastro-oesophageal junction adenocarcinoma or gastrointestinal stromal tumours or solid tumours of colon or lung within 5 years
b. Clinically significant symptom or uncontrolled central nervous system or brain metastases. Patients with treated brain metastases are eligible if there is no evidence of progression for at least 4 weeks after central nervous system-directed treatment, as ascertained by clinical examination and brain imaging (MRI or CT scan) during the Screening period and off steroids (for at least 2 weeks prior to first dose of IP).
c. History or evidence of symptomatic autoimmune pneumonitis, glomerulonephritis, vasculitis, or other symptomatic autoimmune disease, or active autoimmune disease or syndrome that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs) except vitiligo or resolved childhood asthma/atopy or evidence of clinically significant immunosuppression. Replacement therapy (i.e., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
d. Class III or IV heart failure by New York Heart Association classification
e. Uncontrolled hypertension (SBP/ DBP greater than 160/100 mmHg)
f. Active hepatitis B and hepatitis C virus infection
g. Known infection with human immunodeficiency virus
h. History of primary immune deficiency
i. Other active viral infections
j. Thromboembolic disease or bleeding diatheses
k. Severe infection or other uncontrolled active infectious disease requiring antibiotics or antiviral agents that would interfere with the evaluation of safety and efficacy in the judgment of the Investigator.
6. Patients who have received any of the following medications:
a. Administration of granulocyte colony-stimulating factor or platelet transfusion within 2 weeks prior to baseline for correction of ANC or platelet count
b. Patients with therapeutic doses of anticoagulants, sh
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method