A Phase 1/2 interventional study of T3011 in Advanced Melanoma, sponsored by Shanghai Pharmaceuticals Holding Co., Ltd. Recruiting at 7 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-06.
Sponsored by Shanghai Pharmaceuticals Holding Co., Ltd · Phase 1/2, Interventional, and Treatment
Among 202 studies in Melanoma with a site in China — 82 open to participants now, 95 under way, 5 of them phase 3. Melanoma · China.
Among the 202 studies in Melanoma with a site in China, this one is the 113th largest by planned enrollment of the 188 interventional ones that give a count, is one of 12 that started in 2024, is one of 34 in phase 1/2, reaches primary completion later than 34 of the 94 other live ones, and was the 145th registered.
3,370 studies on the registry are indexed under Melanoma; 578 are open to participants now.
Browse Melanoma studies →82 of the 202 studies in Melanoma with a site in China are open now. Recruiting first, the newest first:
Sichuan Baili Pharmaceutical Co., Ltd. · Sites in China
Sun Yat-sen University · Sites in China
Peking University Third Hospital · Sites in China
Bristol-Myers Squibb · Sites in China, United States, Belgium and 10 more countries
Shanghai Henlius Biotech · Sites in China
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 467 Melanoma studies recruiting now, 380 (81%) set no upper age limit and 49 (10%) stop at 75 or younger; 47 take children under 18; 29 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
202 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 91 · Phase 2 109 · Phase 3 13 · Phase 4 2
First in 2008; this study’s year is marked. 12 started in 2024.
This study's planned enrollment of 42 is close to the median of 40 across 2,649 interventional studies indexed under Melanoma.
Median enrollment 52 across the 188 interventional studies, 75 across the 14 observational. Of the 43 that completed or were terminated, 12 (28%) have results posted.
This tab as a report to print or save as PDF → With an account.
100 of 202 have an industry lead sponsor. The 10 most frequent:
Shanghai Pharmaceuticals Holding Co., Ltd is the lead sponsor of 35 studies on the registry; 14 are open to participants now.
Shanghai Pharmaceuticals Holding Co., Ltd has 1 study filed under Melanoma — fewer than ten, so there is no comparison to draw.
24 of the studies in Melanoma with a site in China that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06008106Phase 3Shanghai Kechow Pharma, Inc.Comparing Tunlametinib Capsules and Combination Chemotherapy in Advanced NRAS-mutant Melanoma | 2027-09-22 |
| NCT07280832Shanghai JMT-Bio Inc.Phase I/II Clinical Study of JMT108 Injection for the Treatment of Advanced Malignant Melanoma and Urinary Tract Tumors | 2026-11-30 |
| NCT06359860Beijing Scitech-Mq Pharmaceuticals LimitedA Study of ST-1898 for Unresectable or Metastatic Melanoma | 2026-12 |
| NCT07586891Xijing HospitalExploratory Study With Parallel Controls on the Safety and Efficacy of Neoadjuvant Low Branched-Chain Amino Acid Diet in Combination With Anti-PD-1 Monoclonal Antibody for Stage III Melanoma | 2026-12 |
| NCT07586904Xijing HospitalEfficacy and Safety of Neoadjuvant Cadonilimab Plus High-Dose Recombinant Human Interferon α1b in Stage III/IV Melanoma. | 2026-12 |
Among the 202 studies in Melanoma with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This clinical study evaluated the tolerability, safety and preliminary efficacy of T3011 in subjects with advanced melanoma.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biological: T3011
T3011 will be given intratumorally， Q2W；
Incidence of Treatment-Emergent Adverse Events
Adverse event type, incidence, duration
Time frame: Approximately 2 years
Objective response rate(ORR)
Tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1
Time frame: Approximately 2 years
Disease control rate (DCR)
DCR was defined as the percentage of patients who have achieved complete response, partial response and stable disease
Time frame: Approximately 2 years
Duration of remission (DOR)
DOR was defined for participants who had an objective response as the time from the first occurrence of a documented unconfirmed response to the date of disease progression per RECIST v1.1 or death from any cause.
Time frame: Approximately 2 years
Progression-free survival (PFS)
From the start date of study treatment to the date of progression disease or death , whichever occurred first.
Time frame: Approximately 2 years
Overall Survival (OS)
Determination of the overall survival time of all patients
Time frame: Approximately 2 years
Started Jan 2024 (actual). Primary completion is estimated for Sep 2026, 32 months after the start.
Of 135 industry-sponsored phase 1/2 interventional studies under Melanoma, half reached primary completion within 61 months of starting (the median), counting those still running; a quarter within 41 and three quarters within 84. This study's planned 32 months is below that.
Counting every sponsor, half of 220 studies reached it within 61 months; a quarter within 42 and three quarters within 85.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drug tested here: Oncolytic HSV-1 Expressing IL-12 and Anti-PD-1 Antibody T3011
Shanghai Pharmaceuticals Holding Co., Ltd →