A Clinical Study of T3011 in Subjects With Advanced Melanoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-26

Study Completion Date

2026-09-30

Brief Summary

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

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Detailed Description

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Conditions

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Advanced Melanoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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T3011

Group Type EXPERIMENTAL

T3011

Intervention Type BIOLOGICAL

T3011 will be given intratumorally， Q2W；

Interventions

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T3011

T3011 will be given intratumorally， Q2W；

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No