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

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ClinicalTrials.gov Identifier: NCT04001075
Recruitment Status : Recruiting
First Posted : June 27, 2019
Last Update Posted : July 1, 2019
Sponsor:
Information provided by (Responsible Party):
I-Mab Biopharma HongKong Limited

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).

Condition or disease Intervention/treatment Phase
Advanced Solid Tumord Drug: TJ107 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Two Part, Single-Centre, Open-label, Phase I/IIa, Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TJ107 in Chinese Patients With Advanced Solid Tumors
Actual Study Start Date : February 25, 2019
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : December 2021

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




Primary Outcome Measures :
  1. Dose Limiting Toxicities [ Time Frame: 28days after first dose ]
    Safety and tolerability of TJ107. Incidence of dose-limiting toxicities (DLTs)

  2. Adverse events [ Time Frame: 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

  3. Serious adverse events [ Time Frame: 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 Outcome Measures :
  1. Maximum tolerated dose [ Time Frame: through study completion, an average of 1 year ]
    Maximum tolerated dose (MTD)

  2. Maximum effective dose [ Time Frame: through study completion, an average of 1 year ]
    Maximum effective dose (MED)

  3. Recommended phase II dose [ Time Frame: through study completion, an average of 1 year ]
    Recommended phase II dose (RP2D)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04001075


Contacts
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Contact: Lingling Gu, Master 86-21-60578021 lingling.gu@i-mabbiopharma.com

Locations
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China, Shanghai
Shanghai East Hospital Recruiting
Shanghai, Shanghai, China, 200120
Contact: Jin Li, Doctor    86-21-38804518    lijin@csco.org.cn   
Sponsors and Collaborators
I-Mab Biopharma HongKong Limited

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Responsible Party: I-Mab Biopharma HongKong Limited
ClinicalTrials.gov Identifier: NCT04001075     History of Changes
Other Study ID Numbers: TJ107001STM101
First Posted: June 27, 2019    Key Record Dates
Last Update Posted: July 1, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No