NCT06214156

Brief Summary

This clinical study evaluated the tolerability, safety and preliminary efficacy of T3011 in subjects with advanced melanoma.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P50-P75 for phase_1

Timeline
5mo left

Started Jan 2024

Typical duration for phase_1

Geographic Reach
1 country

7 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Jan 2024Sep 2026

First Submitted

Initial submission to the registry

January 9, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 19, 2024

Completed
7 days until next milestone

Study Start

First participant enrolled

January 26, 2024

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

January 14, 2026

Status Verified

April 1, 2025

Enrollment Period

2.7 years

First QC Date

January 9, 2024

Last Update Submit

January 12, 2026

Conditions

Advanced Melanoma

Outcome Measures

Primary Outcomes (2)

  • Incidence of Treatment-Emergent Adverse Events

    Adverse event type, incidence, duration

    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

    Approximately 2 years

Secondary Outcomes (4)

  • Disease control rate (DCR)

    Approximately 2 years

  • Duration of remission (DOR)

    Approximately 2 years

  • Progression-free survival (PFS)

    Approximately 2 years

  • Overall Survival (OS)

    Approximately 2 years

Study Arms (1)

T3011

EXPERIMENTAL
Biological: T3011

Interventions

T3011BIOLOGICAL

T3011 will be given intratumorally， Q2W；

T3011

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Beijing Cancer Hospital

Beijing, China

RECRUITING

The First Affiliated Hospital of Bengbu Medical College

Bengbu, China

RECRUITING

Jilin Cancer Hospital

Changchun, China

RECRUITING

Chengdu Shangjin Nanfu Hospital

Chengdu, China

RECRUITING

Fujian Cancer Hospital

Fuzhou, China

RECRUITING

The Third People's Hospital of Zhengzhou

Zhengzhou, China

RECRUITING

Sun Yat-sen University Cancer Center

Zhongshan, China

RECRUITING

Central Study Contacts

Jun Guo

CONTACT

0086-010-88196370guoj307@126.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2024

First Posted

January 19, 2024

Study Start

January 26, 2024

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

January 14, 2026

Record last verified: 2025-04

Locations

CN(7)