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Clinical Trials in China / NCT06214156
Recruiting Phase 1/2

A Clinical Study of T3011 in Subjects With Advanced Melanoma

NCT06214156 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai Pharmaceuticals Holding Co., Ltd
Phase
Phase 1/2
Started
2024-01-26
Last updated
2026-08-06

Condition(s) studied

Advanced Melanoma

Investigational drug(s) / intervention(s)

T3011

T3011: T3011 will be given intratumorally, Q2W;

Study summary

This clinical study evaluated the tolerability, safety and preliminary efficacy of T3011 in subjects with advanced melanoma.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (7)

FacilityCityRegionStatus
Beijing Cancer Hospital Beijing China Recruiting
The First Affiliated Hospital of Bengbu Medical College Bengbu China Recruiting
Jilin Cancer Hospital Changchun China Recruiting
Chengdu Shangjin Nanfu Hospital Chengdu China Recruiting
Fujian Cancer Hospital Fuzhou China Recruiting
The Third People's Hospital of Zhengzhou Zhengzhou China Recruiting
Sun Yat-sen University Cancer Center Zhongshan China Recruiting

More Shanghai Pharmaceuticals Holding Co., Ltd trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06214156 on ClinicalTrials.gov ↗ ← All trials in China