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Closed (no longer recruiting)Last updated: 7 February 2024

This Phase I trial is evaluating appropriate dosing levels of an intratumoral therapy (within a tumour) alone, and in combination with immunotherapy (pembrolizumab) in people with advanced solid cancersA First-in-Human Dose Escalation and Expansion Study to Evaluate Intratumoral Administration of ReoCure as Monotherapy and in Combination with Keytruda (Pembrolizumab) in Patients with Advanced Malignant Solid Tumours

Clinical summary

Summary

This is a dose escalation and dose expansion trial. In Part A (ReoCure Monotherapy Dose Escalation) will assess ReoCure at 3 different dose levels. Participants will receive 1 injection every 3 weeks in 3 Cohorts. Part B (ReoCure Combination Therapy Dose Escalation) will test 2 dose levels of ReoCure in combination with fixed dose of pembrolizumab (200mg every 3 weeks) in 2 cohorts. For the Dose Expansion part of the study, ReoCure in combination with a fixed dose of pembrolizumab (200mg once in every 3 weeks) treated with the recommended dose selected from the Dose Escalation part. It is hoped that this study will determine the safest and most effective dose of ReoCure for those with advanced or late stage cancer, and help provide more insight in the effect of ReoCure.

Conditions

This trial is treating patients with advanced solid cancers.

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

ViroCure, Inc.

Scientific Title

A First-in-Human Dose Escalation and Expansion Study to Evaluate Intratumoral Administration of ReoCure as Monotherapy and in Combination with Keytruda (Pembrolizumab) in Patients with Advanced Malignant Solid Tumours

Eligibility

Inclusion

 

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 (especially involving brain tumour):
i. Craniospinal irradiation (greater than 24 Gy) or TBI greater than 3 months prior to Screening
ii. Focal irradiation to symptomatic metastatic sites greater than 2 weeks prior to Screening, if patients have recovered from any AE related to the procedure
iii. Local palliative external beam radiation therapy (XRT) (small port) greater than or equal to 2 weeks, if patients have recovered from any AE related to the procedure
iv. If prior total body irradiation (TBI), craniospinal XRT or if greater than or equal to 50% radiation of pelvis greater than or equal to 6 months must have elapsed
v. If other substantial bone marrow (BM) radiation greater than or equal to 6 weeks must have elapsed.
8. Patients with dermatoses without active infection will be allowed based on case by case prior discussion with study medical monitor, Investigator and Sponsor’s CMO.
9. Male patients must abstain from heterosexual activities or agree to use a condom through 90 days after final dose of study drug. Women of childbearing potential must be willing to abstain from heterosexual activities or agree to use highly effective, double-barrier contraception during the study and for 90 days following the final dose of ReoCure, to avoid pregnancy. Double-barrier contraception is defined as a condom AND one other form of the following:
a. Birth control pills (The Pill)
b. Depot or injectable birth control
c. Intrauterine Device
d. Birth control patch (e.g. Ortho Evra)
e. NuvaRing®
f. Documented evidence of surgical sterilization at least 6 months prior to the Screening Visit, i.e., tubal ligation or hysterectomy for women or vasectomy for men.
Male patients must not donate sperm for at least 24 weeks post-dose of the last study treatment. Male partners of female patients and female partners of male patients must also use contraception as listed above, if they are of childbearing potential.
Female patients of childbearing potential must have a negative serum pregnancy test at Screening and on Day 1.

Exclusion

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, should be excluded from most deep lesion biopsies and injections. However, for deep injections in patients receiving a preventive dose of LMW heparin it is recommended that their LMW heparin treatment is stopped 24 hours before the intratumoral injection and resumed 24 hours after the injection.
c. Patients with current or prior use of immunosuppressive medication within 14 days before the first dose of IP. The following are exceptions to this criterion:
i. Intranasal, inhaled, topical steroids, or local steroid injections (e.g. intra-articular injection)
ii. Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent. Inhaled or topical steroids, and adrenal replacement steroid doses less than or equal to 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease. Inhaled or topical steroids, and adrenal replacement steroid doses less than or equal to 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
iii. Steroids as premedication for hypersensitivity reactions (e.g. computerized tomography [CT] scan premedication)
iv. Receipt of live attenuated vaccine within 30 days prior to the first dose of IP.
v. Note: Patients, if enrolled, should not receive live vaccine while receiving IP and up to 30 days after the last dose of IP.
7. Patients who have received other IP or investigational device within 4 weeks prior to baseline.
8. Patients with any prior Grade 3 or higher immune-related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved Grade >1 irAE (as per NCI-CTCAE version 5.0)
9. Patients with any Grade greater than 1 toxicity (as per NCI-CTCAE version 5.0) related to prior anti-cancer therapy, except those that are deemed not clinically significant by the Investigator in discussion with the study medical monitor, sponsor’s CMO.
10. Patients who, in the opinion of the Investigator, are unsuitable or unable to participate in the study.


Inclusion

  • You have been diagnosed with cancer, but have not received any treatment.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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