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

NCT ID: NCT04001075

Last Updated: 2024-04-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-25
• Study Completion Date: 2021-09-23

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).

Conditions

Advanced Solid Tumord

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TJ107

Patients enrolled in dose escalation part will be given 2 doses (28 days/dose) during the main-treatment period

Group Type: EXPERIMENTAL

TJ107

Intervention Type: DRUG

Patients enrolled in dose escalation part will be given 2 doses (28 days/dose) during the main-treatment period

Interventions

TJ107

Patients enrolled in dose escalation part will be given 2 doses (28 days/dose) during the main-treatment period

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

TJ Biopharma Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The sixth Affiliated Hospital, Sun Yat-sen University

Guanzhou, Guangdong, China

the First Affiliated Hospital of China Medical University

Shenyang, Liaoning, China

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

Sir Run Run Shaw Hospital, affiliated with the Zhejiang University School of the Medical

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

TJ107001STM101

Identifier Type: -

Identifier Source: org_study_id