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

TJ Biopharma Co., Ltd.

Status and phase

Completed

Phase 2

Phase 1

Conditions

Advanced Solid Tumord

Treatments

Drug: TJ107

Study type

Interventional

Funder types

Industry

Identifiers

NCT04001075

TJ107001STM101

Details and patient eligibility

About

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).

Enrollment

32 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.