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Recruiting NCT06214143

A Clinical Study of T3011 in Combination With PD-1/PD-L1 Inhibitors in Subjects With Advanced Solid Tumors

Phase I / Phase II Interventional Advanced Solid Tumors

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: T3011 high dose, T3011 middle dose, T3011 low dose.
Who it may be relevant to
Registry conditions: Advanced Solid Tumors. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

This clinical study evaluated the efficacy and safety of T3011 in combination with PD-1/PD-L1 inhibitors in subjects with advanced solid tumors

Interventions

  • Biological T3011 high dose
    T3011 high dose： T3011 will be given intratumorally，Q2W； PD-1/PD-L1 inhibitor：Administered by intravenous infusion，3 mg/kg，Q2W
  • Biological T3011 middle dose
    T3011 middle dose： T3011 will be given intratumorally，Q2W； PD-1/PD-L1 inhibitor：Administered by intravenous infusion，3 mg/kg，Q2W
  • Biological T3011 low dose
    T3011 low dose： T3011 will be given intratumorally，Q2W； PD-1/PD-L1 inhibitor：Administered by intravenous infusion，3 mg/kg，Q2W

Primary outcome measures

  • Incidence of Treatment-Emergent Adverse Events [Time frame: Approximately 2years]
  • Objective response rate(ORR) [Time frame: Approximately 2years]
Secondary outcome measures (4)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 22 centers
  • Anyang Cancer Hospital — Anyang
  • The First Affiliated Hospital of Bengbu Medical University — Bengbu
  • Hunan cancer hospital — Changsha
  • Sichuan Cancer Hospital — Chengdu
  • Dongguan People's Hospital — Dongwan
  • Fujian Cancer Hospital — Fuzhou
  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Guangzhou
  • The First Affiliated Hospital of Guangdong Pharmaceutical University — Guangzhou
  • … and 14 more centers

Identifiers

NCT: NCT06214143 · SPH-T3011-201

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗