Advanced Solid TumorsPhase 1/2NCT06214143
A Clinical Study of T3011 in Combination With PD-1/PD-L1 Inhibitors in Subjects With Advanced Solid Tumors
A Phase 1/2 study testing T3011 high dose, T3011 middle dose and T3011 low dose in people with Advanced Solid Tumors, run by Shanghai Pharmaceuticals Holding Co., Ltd at 22 sites in China.
Trial summary
This clinical study evaluated the efficacy and safety of T3011 in combination with PD-1/PD-L1 inhibitors in subjects with advanced solid tumors Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- T3011 high dose, T3011 middle dose and T3011 low dose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 22 sitesChina
- Study dates
- 11 Jan 2024to 31 Dec 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 solid tumors;
- 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 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
22 sites in 1 country. Contact the study team or a site near you to ask about taking part.
22 sites in 1 country
China22 sites, 22 recruiting
- Recruiting
Anyang Cancer Hospital
Anyang
Yaowen Zhang
- Recruiting
The First Affiliated Hospital of Bengbu Medical University
Bengbu
Chengyi Jiang
Huan Zhou
- Recruiting
Hunan cancer hospital
Changsha
Feng Liu
Wenxiao Huang
- Recruiting
Sichuan Cancer Hospital
Chengdu
Peng Zhang
- Recruiting
Dongguan People's Hospital
Dongwan
Zhigang Liu
- Recruiting
Fujian Cancer Hospital
Fuzhou
Sufang Qiu
- Recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou
Jinsong Li
- Recruiting
The First Affiliated Hospital of Guangdong Pharmaceutical University
Guangzhou
Xicheng Wang
- Recruiting
Harbin Medical University Cancer Hospital
Ha’erbin
Jin Wu
- Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou
Yulong Zheng
- Recruiting
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou
Ying Yuan
- Recruiting
Shandong cancer hospital
Jinan
Man Hu
- Recruiting
Jiangxi cancer hospital
Nanchang
Jingao Li
- Recruiting
Guangxi Medical University Affiliated Cancer Hospital
Nanning
Song Qu
- Recruiting
Shanghai East Hospital
Shanghai
Ye Guo
- Recruiting
Shanghai Ninth People's Hospital
Shanghai
Guoxin Ren
- Recruiting
Liaoning Cancer Hospital
Shenyang
Zhendong Li
- Recruiting
Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center
Shenzhen
Yan Qin
- Recruiting
Shanxi Cancer Hospital
Taiyuan
Shuqing Wei
- Recruiting
Tianjin cancer hospital
Tianjin
Peiguo Wang
- Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan
Kunyu Yang
- Recruiting
Henan cancer hospital
Zhengzhou
Yanyan Liu
About this study
Official title: A Single-arm, Multi-center Phase Ib/IIa Clinical Study to Evaluate the Tolerability, Safety, and Initial Efficacy of T3011 Herpesvirus Injection Combined With PD-1/PD-L1 Inhibitors in Patients With Advanced Solid Tumors
This clinical study evaluated the efficacy and safety of T3011 in combination with PD-1/PD-L1 inhibitors in subjects with advanced solid tumors
- Conditions
- Advanced Solid Tumors
- Being tested
- T3011 high dose, T3011 middle dose, T3011 low dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T3011 high doseBiological
T3011 high dose： T3011 will be given intratumorally，Q2W； PD-1/PD-L1 inhibitor：Administered by intravenous infusion，3 mg/kg，Q2W
T3011 middle doseBiological
T3011 middle dose： T3011 will be given intratumorally，Q2W； PD-1/PD-L1 inhibitor：Administered by intravenous infusion，3 mg/kg，Q2W
T3011 low doseBiological
T3011 low dose： T3011 will be given intratumorally，Q2W； PD-1/PD-L1 inhibitor：Administered by intravenous infusion，3 mg/kg，Q2W
| Study group | Role | What they receive |
|---|---|---|
| T3011 | Experimental | Not described Receives: Biological: T3011 high dose; Biological: T3011 middle dose; Biological: T3011 low dose |
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 2years
Objective response rate(ORR)
Tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1
Measured: Approximately 2years
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 2years
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 2years
Progression-free survival (PFS)
From the start date of study treatment to the date of progression disease or death , whichever occurred first.
Measured: Approximately 2years
Overall Survival (OS)
Determination of the overall survival time of all patients
Measured: Approximately 2years
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 start11 Jan 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies 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
- 68 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
- NCT06214143
- Sponsor's protocol ID
- SPH-T3011-201
- Status last verified
- Apr 2026
- First submitted
- 9 Jan 2024
- Last updated
- 5 May 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 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Multi-center Phase Ib/IIa Clinical Study to Evaluate the Tolerability, Safety, and Initial Efficacy of T3011 Herpesvirus Injection Combined With PD-1/PD-L1 Inhibitors in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06214143
- Acronym / sponsor ID
- SPH-T3011-201
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Shanghai Pharmaceuticals Holding Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 11 Jan 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 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 efficacy and safety of T3011 in combination with PD-1/PD-L1 inhibitors in subjects with advanced solid tumors
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 high dose, Biological: T3011 middle dose, Biological: T3011 low dose |
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 solid tumors;
- 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 |
|---|---|---|
| T3011 high doseT3011 high dose： T3011 will be given intratumorally，Q2W； PD-1/PD-L1 inhibitor：Administered by intravenous infusion，3 mg/kg，Q2W | Biological | T3011 |
| T3011 middle doseT3011 middle dose： T3011 will be given intratumorally，Q2W； PD-1/PD-L1 inhibitor：Administered by intravenous infusion，3 mg/kg，Q2W | Biological | T3011 |
| T3011 low doseT3011 low dose： T3011 will be given intratumorally，Q2W； PD-1/PD-L1 inhibitor：Administered by intravenous infusion，3 mg/kg，Q2W | Biological | T3011 |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: Approximately 2years
Adverse event type, incidence, duration
Objective response rate(ORR)
Time frame: Approximately 2years
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 2years
Duration of remission (DOR)
Time frame: Approximately 2years
Progression-free survival (PFS)
Time frame: Approximately 2years
Overall Survival (OS)
Time frame: Approximately 2years
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 5 May 2026.
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
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A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
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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.
22 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 high dose, T3011 middle dose and T3011 low dose in people with Advanced Solid Tumors, run by Shanghai Pharmaceuticals Holding Co., Ltd at 22 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 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 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 Ye Guo (0086-021-38804518, pattrickguo@mail.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 2years). 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 5 May 2026.