RecruitingPhase 1/2

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

China68 participantsStarted 2024-01-11

Plain-language summary

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

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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;

Incidence of Treatment-Emergent Adverse Events

Timeframe: Approximately 2years

Objective response rate(ORR)

Timeframe: Approximately 2years

NCT IDNCT06214143

SponsorShanghai Pharmaceuticals Holding Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12-31

Ye Guo

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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;