NCT06214156 A Clinical Study of T3011 in Subjects With Advanced Melanoma
| NCT ID | NCT06214156 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Shanghai Pharmaceuticals Holding Co., Ltd |
| Condition | Advanced Melanoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 42 participants |
| Start Date | 2024-01-26 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 42 participants in total. It began in 2024-01-26 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This clinical study evaluated the tolerability, safety and preliminary efficacy of T3011 in subjects with advanced melanoma.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06214156 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Advanced Melanoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06214156 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06214156 currently recruiting?
Yes, NCT06214156 is actively recruiting participants. Contact the research team at guoj307@126.com for enrollment information.
Where is the NCT06214156 trial being conducted?
This trial is being conducted at Beijing, China, Bengbu, China, Changchun, China, Chengdu, China and 3 additional locations.
Who is sponsoring the NCT06214156 clinical trial?
NCT06214156 is sponsored by Shanghai Pharmaceuticals Holding Co., Ltd. The trial plans to enroll 42 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.