Advanced Solid Tumord
Conditions
Brief summary
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).
Interventions
DRUGTJ107
Patients enrolled in dose escalation part will be given 2 doses (28 days/dose) during the main-treatment period
Sponsors
TJ Biopharma Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose Limiting Toxicities | 28days after first dose | Safety and tolerability of TJ107. Incidence of dose-limiting toxicities (DLTs) |
| Adverse events | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months | Safety and tolerability of TJ107. Incidence of adverse events |
| Serious adverse events | through study completion, an average of 1 year | Safety and tolerability of TJ107. Incidence of serious adverse events by National Cancer Institute Common Terminology Criteria for Adverse Events(CI CTCAE 5.0) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum tolerated dose | through study completion, an average of 1 year | Maximum tolerated dose (MTD) |
| Maximum effective dose | through study completion, an average of 1 year | Maximum effective dose (MED) |
| Recommended phase II dose | through study completion, an average of 1 year | Recommended phase II dose (RP2D) |
Countries
China
Outcome results
None listed