Phase
Condition
Melanoma
Metastatic Melanoma
Treatment
T3011
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subjects with advanced melanoma;
At least one measurable lesion;
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
Expected survival > 12 weeks;
Laboratory inspection meets the requirements;
For women of childbearing potential, the serum pregnancy test results must benegative within 7 days prior to the first dose,and effective contraceptive measuresmust be taken from signing the informed consent form (ICF) until at least 6 monthsafter the last dose;
Male subjects of childbearing potential agree to use effective contraception fromsigning the ICF until at least 6 months after the last dose; In addition, malesubjects must agree not to donate sperm during this period;
Understand and voluntarily sign the ICF,willing and able to comply with allexperimental requirements.
Exclusion
Exclusion Criteria:
Subjects who have received other antitumor therapy within the prescribed time priorto the first dose;
Subjects with a history of other malignancies within the prescribed time prior tothe start of study treatment.
At screening, subjects with a history or evidence of high risk cardiovasculardisease;
Subjects with persistent or active infection requiring intravenous anti-infectivetherapy;
Subjects with autoimmune diseases or a history of autoimmune diseases;
Subjects with known psychiatric disorders that may affect trial compliance;
Subjects who have pleural effusion, pericardial effusion, or ascites before startingtreatment and require puncture drainage, or who had received puncture drainagewithin the specified time before starting the study treatment;
Subjects requiring systemic treatment with anti-HSV drugs during the study period;
Subjects who have received live or attenuated vaccines within the prescribed timeprior to the first dose, or who plan to receive such vaccines during the studyperiod; Subjects who have received any tumor vaccine in the past;
Subjects who had undergone major surgery within the prescribed time before the firstdose,and had not recovered from surgery-related adverse reactions or were still inthe postoperative recovery period,or who plan to undergo major surgery during thestudy period;
Subjects with a history of drug use,drug abuse or alcohol abuse within the yearprior to signing the ICF;
Female subjects who are pregnant or breastfeeding, or planning to conceive or havechildren during the study period;
The investigator considers it inappropriate to participate in this study.
Study Design
Connect with a study center
Beijing Cancer Hospital
Beijing,
ChinaActive - Recruiting
The First Affiliated Hospital of Bengbu Medical College
Bengbu,
ChinaActive - Recruiting
Jilin Cancer Hospital
Changchun,
ChinaActive - Recruiting
Chengdu Shangjin Nanfu Hospital
Chengdu,
ChinaActive - Recruiting
Fujian Cancer Hospital
Fuzhou,
ChinaActive - Recruiting
The Third People's Hospital of Zhengzhou
Zhengzhou,
ChinaActive - Recruiting
Sun Yat-sen University Cancer Center
Zhongshan,
ChinaActive - Recruiting
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