Advanced MelanomaPhase 1/2NCT06214156
A Clinical Study of T3011 in Subjects With Advanced Melanoma
A Phase 1/2 study testing T3011 in people with Advanced Melanoma, run by Shanghai Pharmaceuticals Holding Co., Ltd at 7 sites in China.
Trial summary
This clinical study evaluated the tolerability, safety and preliminary efficacy of T3011 in subjects with advanced melanoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Melanoma
- What is being tested?
- T3011
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 7 sitesChina
- Study dates
- 26 Jan 2024to 30 Sep 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with advanced melanoma;
- At least one measurable lesion;
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
- Expected survival > 12 weeks;
- Laboratory inspection meets the requirements;
- 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;
- 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;
- Understand and voluntarily sign the ICF，willing and able to comply with all experimental requirements.
Who cannot join
- Subjects who have received other antitumor therapy within the prescribed time prior to the first dose;
- Subjects with a history of other malignancies within the prescribed time prior to the start of study treatment.
- At screening, subjects with a history or evidence of high risk cardiovascular disease;
- Subjects with persistent or active infection requiring intravenous anti-infective therapy;
- Subjects with autoimmune diseases or a history of autoimmune diseases;
- Subjects with known psychiatric disorders that may affect trial compliance;
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- 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;
- Subjects requiring systemic treatment with anti-HSV drugs during the study period;
- 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;
- 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;
- Subjects with a history of drug use，drug abuse or alcohol abuse within the year prior to signing the ICF;
- Female subjects who are pregnant or breastfeeding, or planning to conceive or have children during the study period;
- The investigator considers it inappropriate to participate in this study.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
China7 sites, 7 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing
Jun Guo
- Recruiting
The First Affiliated Hospital of Bengbu Medical College
Bengbu
Mingxi Wang
- Recruiting
Jilin Cancer Hospital
Changchun
Xueying Zhang
- Recruiting
Chengdu Shangjin Nanfu Hospital
Chengdu
Yaotiao Deng
- Recruiting
Fujian Cancer Hospital
Fuzhou
Yu Chen
- Recruiting
The Third People's Hospital of Zhengzhou
Zhengzhou
Xianbin Liang
- Recruiting
Sun Yat-sen University Cancer Center
Zhongshan
Xiaoshi Zhang
About this study
Official title: A Phase Ib/IIa Clinical Study to Evaluate the Tolerability, Safety and Preliminary Efficacy of T3011 in Subjects With Advanced Melanoma
This clinical study evaluated the tolerability, safety and preliminary efficacy of T3011 in subjects with advanced melanoma.
- Conditions
- Advanced Melanoma
- Being tested
- T3011
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T3011Biological
T3011 will be given intratumorally， Q2W；
| Study group | Role | What they receive |
|---|---|---|
| T3011 | Experimental | Not described Receives: Biological: T3011 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events
Adverse event type, incidence, duration
Measured: 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
Measured: Approximately 2 years
Secondary outcomes (4)
Disease control rate (DCR)
DCR was defined as the percentage of patients who have achieved complete response, partial response and stable disease
Measured: 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.
Measured: 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.
Measured: Approximately 2 years
Overall Survival (OS)
Determination of the overall survival time of all patients
Measured: Approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start26 Jan 2024
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced MelanomaStudies of the same condition, open and under way.
- More trials run by Shanghai Pharmaceuticals Holding Co., LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Pharmaceuticals Holding Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06214156
- Sponsor's protocol ID
- SPH-T3011-202
- Status last verified
- Aug 2026
- First submitted
- 9 Jan 2024
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/IIa Clinical Study to Evaluate the Tolerability, Safety and Preliminary Efficacy of T3011 in Subjects With Advanced Melanoma
- ClinicalTrials.gov ID
- NCT06214156
- Acronym / sponsor ID
- SPH-T3011-202
- Conditions
- Advanced Melanoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Shanghai Pharmaceuticals Holding Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 26 Jan 2024 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 19 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical study evaluated the tolerability, safety and preliminary efficacy of T3011 in subjects with advanced melanoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| T3011 | Experimental | Biological: T3011 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects with advanced melanoma;
- At least one measurable lesion;
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
- Expected survival > 12 weeks;
- Laboratory inspection meets the requirements;
Key exclusion criteria (13 listed)
- Subjects who have received other antitumor therapy within the prescribed time prior to the first dose;
- Subjects with a history of other malignancies within the prescribed time prior to the start of study treatment.
- At screening, subjects with a history or evidence of high risk cardiovascular disease;
- Subjects with persistent or active infection requiring intravenous anti-infective therapy;
- Subjects with autoimmune diseases or a history of autoimmune diseases;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T3011T3011 will be given intratumorally， Q2W； | Biological | T3011 |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: Approximately 2 years
Adverse event type, incidence, duration
Objective response rate(ORR)
Time frame: Approximately 2 years
Tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1
4 secondary outcomes
Disease control rate (DCR)
Time frame: Approximately 2 years
Duration of remission (DOR)
Time frame: Approximately 2 years
Progression-free survival (PFS)
Time frame: Approximately 2 years
Overall Survival (OS)
Time frame: Approximately 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
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A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced Melanoma
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing T3011 in people with Advanced Melanoma, run by Shanghai Pharmaceuticals Holding Co., Ltd at 7 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jun Guo (0086-010-88196370, guoj307@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (time frame: Approximately 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.