Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TJ107 in Chinese Patients With Advanced Solid Tumors

A Phase I/IIa, Open-label, Dose-Escalation and Dose Expansion Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TJ107 in Chinese Patients With Advanced Solid Tumors

This is a two-part study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of TJ107 in Chinese patients with advanced solid tumors. Approximately a total of 36 ~ 60 patients will be enrolled into the dose escalation cohorts (Part A), and expansion cohorts (Part B).

Inclusion Criteria:

• Aged at least 18 years old;
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0~2;
• Patients must have histological or cytological confirmation of advanced solid tumors that is refractory to standard therapy or for which there is no standard available therapy;
• Predicted life expectancy ≥3 months;
• Patients must have adequate organ and marrow function;
• Patients at reproductive age should take adequate contraceptive measures while on study drug and for 6 months following the last dose of study drug.
• Patients should have the ability and willingness to comply with the study and follow up. And patients must be able to provide written informed consent.

Exclusion Criteria:

• Patients who have experienced a Grade 3 or higher toxicity related to prior immunotherapy.
• Patients who are still receive anti-tumor therapy such as radiotherapy, chemotherapy, targeted therapy, endocrine therapy, or other clinical trials from 4 weeks prior to the first dose, or patients who have not recovered from previous toxicity to level 1.
• Women who are pregnant or breast feeding
• Patients who are drug-dependent or have a history of substance abuse or psychonosema history.
• Have been vaccinated within 4 weeks of study dosing, with the exception of licensed intranasal or intramuscular influenza vaccine during study
• Prior allogeneic bone marrow transplantation or prior solid organ transplantation
• Positive laboratory test for HBsAg with HBV DNA ≥ 100 IU/mL, or positive laboratory test for HCV.
• Prior treatment with immune checkpoint inhibitors, immunomodulatory mAbs, and/or mAb-derived therapies is allowed provided that at least 3 months or 5 half-lives of the drug, whichever is longer, have elapsed from the last dose.
• Uncontrolled concurrent illness.
• Major surgery procedure (excluding diagnostic surgery) within 4 weeks of the first dose of study drug.
• Patients with a history of treated CNS metastases.
• Other psychiatric illness/social situations that would limit compliance with the study requirements decided by the investigator.