A Clinical Study of T3011 in Subjects With Advanced Melanoma

Last updated: April 10, 2025
Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd
Overall Status: Active - Recruiting

Phase

1/2

Condition

Melanoma

Metastatic Melanoma

Treatment

T3011

Clinical Study ID

NCT06214156
SPH-T3011-202
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 benegative within 7 days prior to the first dose,and effective contraceptive measuresmust be taken from signing the informed consent form (ICF) until at least 6 monthsafter the last dose;

  7. Male subjects of childbearing potential agree to use effective contraception fromsigning the ICF until at least 6 months after the last dose; In addition, malesubjects must agree not to donate sperm during this period;

  8. Understand and voluntarily sign the ICF,willing and able to comply with allexperimental requirements.

Exclusion

Exclusion Criteria:

  1. Subjects who have received other antitumor therapy within the prescribed time priorto the first dose;

  2. Subjects with a history of other malignancies within the prescribed time prior tothe start of study treatment.

  3. At screening, subjects with a history or evidence of high risk cardiovasculardisease;

  4. Subjects with persistent or active infection requiring intravenous anti-infectivetherapy;

  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 startingtreatment and require puncture drainage, or who had received puncture drainagewithin 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 timeprior to the first dose, or who plan to receive such vaccines during the studyperiod; Subjects who have received any tumor vaccine in the past;

  10. Subjects who had undergone major surgery within the prescribed time before the firstdose,and had not recovered from surgery-related adverse reactions or were still inthe postoperative recovery period,or who plan to undergo major surgery during thestudy period;

  11. Subjects with a history of drug use,drug abuse or alcohol abuse within the yearprior to signing the ICF;

  12. Female subjects who are pregnant or breastfeeding, or planning to conceive or havechildren during the study period;

  13. The investigator considers it inappropriate to participate in this study.

Study Design

Total Participants: 42
Treatment Group(s): 1
Primary Treatment: T3011
Phase: 1/2
Study Start date:
January 26, 2024
Estimated Completion Date:
September 30, 2025

Connect with a study center

  • Beijing Cancer Hospital

    Beijing,
    China

    Active - Recruiting

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu,
    China

    Active - Recruiting

  • Jilin Cancer Hospital

    Changchun,
    China

    Active - Recruiting

  • Chengdu Shangjin Nanfu Hospital

    Chengdu,
    China

    Active - Recruiting

  • Fujian Cancer Hospital

    Fuzhou,
    China

    Active - Recruiting

  • The Third People's Hospital of Zhengzhou

    Zhengzhou,
    China

    Active - Recruiting

  • Sun Yat-sen University Cancer Center

    Zhongshan,
    China

    Active - Recruiting

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