New hope for advanced melanoma: T3011 trial launches
NCT ID NCT06214156
First seen Jun 27, 2026 · Last updated Aug 07, 2026 · Updated 2 times
Summary
This study tests a new drug, T3011, in 42 people with advanced melanoma that has spread. The main goals are to check safety and see if tumors shrink. Participants must have measurable tumors and be in good overall health.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 42 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2024
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
7 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Beijing Cancer Hospital
RECRUITINGBeijing, China
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Chengdu Shangjin Nanfu Hospital
RECRUITINGChengdu, China
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Fujian Cancer Hospital
RECRUITINGFuzhou, China
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Jilin Cancer Hospital
RECRUITINGChangchun, China
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Sun Yat-sen University Cancer Center
RECRUITINGZhongshan, China
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The First Affiliated Hospital of Bengbu Medical College
RECRUITINGBengbu, China
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The Third People's Hospital of Zhengzhou
RECRUITINGZhengzhou, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a PET scan find the best tumor site for harvesting Cancer-Fighting cells?
- Can a DNA vaccine teach the immune system to hunt melanoma?
- Can a new biologic drug shrink advanced melanoma tumors?
- Engineered immune cells take aim at Hard-to-Treat cancers
- Could a diabetes drug boost immunotherapy in advanced melanoma?
- New combo therapy takes on advanced cancers