A Clinical Study of T3011 in Subjects With Advanced Melanoma

August 5, 2026 updated by: Shanghai Pharmaceuticals Holding Co., Ltd

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

42

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Beijing Cancer Hospital
        • Contact:
          • Jun Guo
      • Bengbu, China
        • Recruiting
        • The First Affiliated Hospital of Bengbu Medical College
        • Contact:
          • Mingxi Wang
      • Changchun, China
        • Recruiting
        • Jilin Cancer Hospital
        • Contact:
          • Xueying Zhang
      • Chengdu, China
        • Recruiting
        • Chengdu Shangjin Nanfu Hospital
        • Contact:
          • Yaotiao Deng
      • Fuzhou, China
        • Recruiting
        • Fujian Cancer Hospital
        • Contact:
          • Yu Chen
      • Zhengzhou, China
        • Recruiting
        • The Third People's Hospital of Zhengzhou
        • Contact:
          • Xianbin Liang
      • Zhongshan, China
        • Recruiting
        • Sun Yat-Sen University Cancer Center
        • Contact:
          • Xiaoshi Zhang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: T3011
Biological: T3011
T3011 will be given intratumorally， Q2W；

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Approximately 2 years
Incidence of Treatment-Emergent Adverse Events
Time Frame: Approximately 2 years
Adverse event type, incidence, duration
Approximately 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS)
Time Frame: Approximately 2 years
From the start date of study treatment to the date of progression disease or death , whichever occurred first.
Approximately 2 years
Duration of remission (DOR)
Time Frame: Approximately 2 years
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.
Approximately 2 years
Disease control rate (DCR)
Time Frame: Approximately 2 years
DCR was defined as the percentage of patients who have achieved complete response, partial response and stable disease
Approximately 2 years
Overall Survival (OS)
Time Frame: Approximately 2 years
Determination of the overall survival time of all patients
Approximately 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Pharmaceuticals Holding Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 26, 2024

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

January 9, 2024

First Submitted That Met QC Criteria

January 9, 2024

First Posted (Actual)

January 19, 2024

Study Record Updates

Last Update Posted (Actual)

August 6, 2026

Last Update Submitted That Met QC Criteria

August 5, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPH-T3011-202

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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