Clinical trial NCT04001075: Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TJ107 in Chinese Patients With Advanced Solid Tumors
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Advanced Solid Tumord
Lead sponsor: TJ Biopharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-06-27
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Dose Limiting Toxicities
timeFrame: 28days after first dose
measure: Adverse events
timeFrame: 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
measure: Serious adverse events
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Maximum tolerated dose
timeFrame: through study completion, an average of 1 year
measure: Maximum effective dose
timeFrame: through study completion, an average of 1 year
measure: Recommended phase II dose
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Guanzhou
country: China
facility: The sixth Affiliated Hospital, Sun Yat-sen University
state: Guangdong
city: Shenyang
country: China
facility: the First Affiliated Hospital of China Medical University
state: Liaoning
city: Shanghai
country: China
facility: Shanghai East Hospital
state: Shanghai
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital, affiliated with the Zhejiang University School of the Medical
state: Zhejiang
Study officials:
References: