Status:
RECRUITING
A Clinical Study of T3011 in Subjects With Advanced Melanoma
Lead Sponsor:
Shanghai Pharmaceuticals Holding Co., Ltd
Conditions:
Advanced Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This clinical study evaluated the tolerability, safety and preliminary efficacy of T3011 in subjects with advanced melanoma.
Eligibility Criteria
Inclusion
- 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 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;
- 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;
- Understand and voluntarily sign the ICF，willing and able to comply with all experimental requirements.
Exclusion
- Subjects who have received other antitumor therapy within the prescribed time prior to the first dose;
- Subjects with a history of other malignancies within the prescribed time prior to the start of study treatment.
- At screening, subjects with a history or evidence of high risk cardiovascular disease;
- Subjects with persistent or active infection requiring intravenous anti-infective therapy;
- 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 starting treatment and require puncture drainage, or who had received puncture drainage within 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 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;
- 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;
- Subjects with a history of drug use，drug abuse or alcohol abuse within the year prior to signing the ICF;
- Female subjects who are pregnant or breastfeeding, or planning to conceive or have children during the study period;
- The investigator considers it inappropriate to participate in this study.
Key Trial Info
Start Date :
January 26 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2025
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT06214156
Start Date
January 26 2024
End Date
September 30 2025
Last Update
April 11 2025
Active Locations (7)
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1
Beijing Cancer Hospital
Beijing, China
2
The First Affiliated Hospital of Bengbu Medical College
Bengbu, China
3
Jilin Cancer Hospital
Changchun, China
4
Chengdu Shangjin Nanfu Hospital
Chengdu, China