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Trial Title:
A Clinical Study of T3011 in Subjects With Advanced Melanoma
NCT ID:
NCT06214156
Condition:
Advanced Melanoma
Conditions: Official terms:
Melanoma
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
T3011
Description:
T3011 will be given intratumorally， Q2W；
Arm group label:
T3011
Summary:
This clinical study evaluated the tolerability, safety and preliminary efficacy of T3011
in subjects with advanced melanoma.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Subjects with advanced melanoma;
2. At least one measurable lesion;
3. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
4. Expected survival > 12 weeks;
5. Laboratory inspection meets the requirements;
6. For women of childbearing potential, the serum pregnancy test results must be
negative within 7 days prior to the first dose，and effective contraceptive measures
must be taken from signing the informed consent form (ICF) until at least 6 months
after the last dose;
7. Male subjects of childbearing potential agree to use effective contraception from
signing the ICF until at least 6 months after the last dose; In addition, male
subjects must agree not to donate sperm during this period;
8. Understand and voluntarily sign the ICF，willing and able to comply with all
experimental requirements.
Exclusion Criteria:
1. Subjects who have received other antitumor therapy within the prescribed time prior
to the first dose;
2. Subjects with a history of other malignancies within the prescribed time prior to
the start of study treatment.
3. At screening, subjects with a history or evidence of high risk cardiovascular
disease;
4. Subjects with persistent or active infection requiring intravenous anti-infective
therapy;
5. Subjects with autoimmune diseases or a history of autoimmune diseases;
6. Subjects with known psychiatric disorders that may affect trial compliance;
7. Subjects who have pleural effusion, pericardial effusion, or ascites before starting
treatment and require puncture drainage, or who had received puncture drainage
within the specified time before starting the study treatment;
8. Subjects requiring systemic treatment with anti-HSV drugs during the study period;
9. Subjects who have received live or attenuated vaccines within the prescribed time
prior to the first dose, or who plan to receive such vaccines during the study
period; Subjects who have received any tumor vaccine in the past;
10. Subjects who had undergone major surgery within the prescribed time before the first
dose，and had not recovered from surgery-related adverse reactions or were still in
the postoperative recovery period，or who plan to undergo major surgery during the
study period;
11. Subjects with a history of drug use，drug abuse or alcohol abuse within the year
prior to signing the ICF;
12. Female subjects who are pregnant or breastfeeding, or planning to conceive or have
children during the study period;
13. The investigator considers it inappropriate to participate in this study.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Cancer Hospital
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Jun Guo
Facility:
Name:
The First Affiliated Hospital of Bengbu Medical College
Address:
City:
Bengbu
Country:
China
Status:
Recruiting
Contact:
Last name:
Mingxi Wang
Facility:
Name:
Jilin Cancer Hospital
Address:
City:
Changchun
Country:
China
Status:
Recruiting
Contact:
Last name:
Xueying Zhang
Facility:
Name:
Chengdu Shangjin Nanfu Hospital
Address:
City:
Chengdu
Country:
China
Status:
Recruiting
Contact:
Last name:
Yaotiao Deng
Facility:
Name:
Fujian Cancer Hospital
Address:
City:
Fuzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Yu Chen
Facility:
Name:
The Third People's Hospital of Zhengzhou
Address:
City:
Zhengzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Xianbin Liang
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Zhongshan
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaoshi Zhang
Start date:
January 26, 2024
Completion date:
July 30, 2025
Lead sponsor:
Agency:
Shanghai Pharmaceuticals Holding Co., Ltd
Agency class:
Industry
Source:
Shanghai Pharmaceuticals Holding Co., Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06214156
