Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years - 70 Years|
Inclusion Criteria:1. Obtain the current IRB approved informed consent with written from potential patients before the any screening activities or procedures. 2. Male or female, ≥ 18 years and ≤ 70 years of age. 3. Patients with histologically proven unresectable stage IIIb /IIIc or IV (M1a/M1b) malignant melanoma following AJCC edition 8 published 2016 guidance. If patient in stage IV (M1b), pulmonary lesion as following: number of pulmonary lesion must be ≤ 5; any single lesion must less than 20 mm in longest diameter; total cumulative diameter of all lesions must be ≤ 50 mm; 4. Patients with at least one measurable lesion with size ≥ 10 mm and < 100mm. 5. Patient with at least one injectable lesion (long diameter ≥ 10 mm and < 100mm. 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. 7. Patients with life expectancy > 5 months as judged by investigator. 8. Patients with adequate bone marrow, liver and renal function within 28 days prior to study entry, as defined by the following:
- - White Blood Cell count ≥3.0 × 109/L.
- - Absolute neutrophil count (ANC) ≥ 1.5 × 109/L.
- - Platelet count≥ 100 × 109/L.
- - Hemoglobin > 10.0 g/dl.
- - Albumin ≥ 3 g/dl.
- - liver function: Total bilirubin ≤ 1.5 x upper normal limit (UNL) , Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 x upper normal limit (UNL).
- - renal function: serum creatinine < 1.5 x UNL or 24 hour creatinine clearance rate≥ 50 mL/min（calculated by Cockcroft and Gault） - International normalized ratio (INR) < 1.5 and Activated partial thromboplastin time (APTT) or Partial thromboplastin time (PTT) ≤ 1.5 × ULN.
Exclusion Criteria:1. Patients that have previously been treated with dacarbazine. 2. Previous treatment with any investigational product or T-VEC or other similar ' oncolytic' viruses therapy. 3. Sizes of tumor does not meet the requirement of injection or unacceptable for intratumoral injection. 4. Patients who have treatment with anti-HSV antiviral therapy (such as acyclovir, ganciclovir, foscarnet, etc.) within 4 weeks prior to the first IP administration. 5. No history of malignancy within the past 5 years except for the following: adequately treated of stage I or II basal cell/squamous cell skin cancer, superficial bladder cancer or any other cancer from which the patient has been completed curative therapy. 6. Patients with known or suspected allergies and/or hypersensitivity to any component of OrienX10 or Dacarbazine. 7. HSV
- - 1 antibody IgG and IgM are negative.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|OrienGene Biotechnology Ltd.|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Jun Guo, MD|
|Principal Investigator Affiliation||Peking University Cancer Hospital & Institute|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
Experimental: treatment group
OrienX010 will be administered once every two weeks by intratumoral injection. The treatment dose , depends on the patient's tumour size, The maximum dose of OrienX010 in at each treatment , the expected accumulated dose in 10 mL. The investigator should be confirmed the injectable tumor size and adequate dose within 24 hours prior to treatment. OrienX010 treatment will be continuous and extend from first dose of study medication until to complete response, clinical related progression disease (PDr), untolerated toxicities, lost to follow up, death or meet end of treatment criteria.
Active Comparator: Control group
Dacarbazine will be administered once every three weeks by intravenous 1000mg/square meter. Dacarbazine treatment will be continuous and extend from first dose of study medication until to progression disease (PD), untolerated toxicities, lost to follow up, death or meet end of treatment criteria.
Biological: - OrienX010 injection
OrienX010 to be used in this study have been developed and manufactured by OrienGene Biotechnology Ltd. Dacarbazine to be used in this study was manufactured by Sinopharm A-Think Pharmaceutical Co., Ltd.
Drug: - Dacarbazine (DTIC)
Dacarbazine to be used in this study was manufactured by Sinopharm A-Think Pharmaceutical Co., Ltd.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.