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

NCT04001075 | Completed Phase 1

• 1 other identifier: TJ107001STM101
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 4

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

Outcome Measures

Primary Outcomes (3)

• Dose Limiting Toxicities

  Safety and tolerability of TJ107. Incidence of dose-limiting toxicities (DLTs)

  28days after first dose

• Adverse events

  Safety and tolerability of TJ107. Incidence of 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

• Serious adverse events

  Safety and tolerability of TJ107. Incidence of serious adverse events by National Cancer Institute Common Terminology Criteria for Adverse Events(CI CTCAE 5.0)

  through study completion, an average of 1 year

Secondary Outcomes (3)

• Maximum tolerated dose

  through study completion, an average of 1 year

• Maximum effective dose

  through study completion, an average of 1 year

• Recommended phase II dose

  through study completion, an average of 1 year

Study Arms (1)

TJ107

EXPERIMENTAL

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

Drug: TJ107

Interventions

TJ107 DRUG

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

TJ107

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• TJ Biopharma Co., Ltd.: lead

Study Sites (4)

The sixth Affiliated Hospital, Sun Yat-sen University

Guanzhou, Guangdong, 510655, China

Location

the First Affiliated Hospital of China Medical University

Shenyang, Liaoning, 110001, China

Location

Shanghai East Hospital

Shanghai, Shanghai Municipality, 200120, China

Location

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

Hangzhou, Zhejiang, 310016, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2019
• First Posted: June 27, 2019
• Study Start: February 25, 2019
• Primary Completion: June 30, 2021
• Study Completion: September 23, 2021
• Last Updated: April 15, 2024

Record last verified: 2024-04

Locations

CN (4)