A Clinical Study of T3011 in Subjects With Advanced Melanoma

Launched by SHANGHAI PHARMACEUTICALS HOLDING CO., LTD · Jan 9, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called T3011 for patients with advanced melanoma, which is a serious type of skin cancer. The main goals of the study are to see how well the treatment is tolerated by patients, its safety, and if it shows any early signs of being effective. The trial is currently looking for participants aged 65 to 74 who have advanced melanoma and at least one measurable tumor. To join, participants should generally be in good health, expected to live for more than 12 weeks, and meet certain lab test requirements.

Eligible participants can expect to undergo regular check-ups during the study to monitor their health and the effects of T3011. It's important that women who can become pregnant have a negative pregnancy test and use effective birth control, while men must also agree to use contraception during the study. There are several criteria that would exclude someone from participating, such as recent cancer treatments or certain health conditions. If you or a loved one is interested in learning more about this trial, it could be a chance to explore a new treatment option for advanced melanoma.

Gender

ALL

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.