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

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

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).

Study Overview

• Status: Completed
• Conditions: Advanced Solid Tumord
• Intervention / Treatment: Drug: TJ107

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guanzhou, Guangdong, China, 510655
      • The Sixth Affiliated Hospital, Sun Yat-sen University
  • Liaoning
    • Shenyang, Liaoning, China, 110001
      • The First Affiliated Hospital of China Medical University
  • Shanghai
    • Shanghai, Shanghai, China, 200120
      • Shanghai East Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310016
      • Sir Run Run Shaw Hospital, affiliated with the Zhejiang University School of the Medical

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TJ107; Patients enrolled in dose escalation part will be given 2 doses (28 days/dose) during the main-treatment period	Drug: TJ107; Patients enrolled in dose escalation part will be given 2 doses (28 days/dose) during the main-treatment period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum tolerated dose	Maximum tolerated dose (MTD)	through study completion, an average of 1 year
Maximum effective dose	Maximum effective dose (MED)	through study completion, an average of 1 year
Recommended phase II dose	Recommended phase II dose (RP2D)	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: TJ Biopharma Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2019
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): September 23, 2021

Study Registration Dates

• First Submitted: June 23, 2019
• First Submitted That Met QC Criteria: June 26, 2019
• First Posted (Actual): June 27, 2019

Study Record Updates

• Last Update Posted (Estimated): April 15, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: TJ107001STM101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No