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A Phase I/II Study of TJ004309 for Advanced Solid Tumor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04322006
Recruitment Status : Recruiting
First Posted : March 26, 2020
Last Update Posted : March 14, 2023
Information provided by (Responsible Party):
I-Mab Biopharma Co. Ltd.

Brief Summary:
This study is a phase I/II study of single drug TJ004309 and Toripalimab combine treatment for Advanced solid tumor. This study include two stages. First stage is dose escalation and second stage is dose extension. The purpose of part A is to confirm the MTD or MED and the clinical dose. The purpose of part B is to observe the safety, effectiveness, Pharmacokinetics, pharmacodynamics and biomarker properties for effective subjects.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Drug: TJ004309 Drug: Toripalimab Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 376 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Study of Evaluating the Safety, Tolerance, Pharmacokinetics, Pharmacodynamics and Curative Effect of Dose Escalation and Extension for Single Drug TJ004309 and Toripalimab Combine Treatment for Advanced Solid Tumor
Actual Study Start Date : May 9, 2020
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Arm Intervention/treatment
Experimental: TJ004309 injection Monotherapy or Combination with Toripalimab
TJ004309 will be dose escalated in a 3+3 design in Monotherapy or combination with Toripalimab
Drug: TJ004309
Antibody to CD73

Drug: Toripalimab
Humanized monoclonal antibody to PD-1

Primary Outcome Measures :
  1. Dose Limiting Toxicities(DLT) [ Time Frame: 28days after first dose for QW, 21days after first dose for Q3W ]
    The safety and tolerance of TJ004309

  2. MTD [ Time Frame: 2 years ]
    Maximum tolerated dose (MTD)

  3. MED [ Time Frame: 2 years ]
    Maximum effective dose (MED)

  4. Recommend dose of TJ004309 [ Time Frame: 2 years ]
    Recommend dose of TJ004309

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

Inclusion Criteria:

  • Age ≥ 18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1
  • In the dose-escalation phase, subjects with advanced solid tumors that are histologically or cytologically confirmed to be unresectable or have metastasized, subjects with standard treatment failure or intolerance (disease progression, or inability to tolerate chemotherapy, targeted therapy, etc.), or subjects without effective treatment.
  • Synchronous dose expansion (will base on dose-escalation phase)
  • At least one measurable disease by modified RECIST 1.1 for immune based therapeutics V1.1
  • Expected survival ≥ 3 months
  • Adequate organ function as defined by the following criteria:

    • Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤ 2.5 times upper limit of normal (ULN)
    • Total serum bilirubin ≤ 1.5 times the ULN
    • Absolute neutrophil count (ANC) ≥ 1.5 ×109/ L
    • Platelets ≥ 100×109/ L without transfusion support within 28 days prior to study treatment
    • Hemoglobin ≥ 9.0 g/dL without transfusion support within 14 days prior to study treatment
    • Serum creatinine ≤ 1.5 times the ULN or Creatinine clearance > 30 mL/min by Cockcroft-Gault formula
    • International normalized ratio (INR) in normal range
  • Serum pregnancy test must be negative for childbearing female prior to study treatment
  • The man have reproductive ability or childbearing female (refers to men and women not on birth control operation, and the menopause women), must use the highly effective contraceptive methods (such as oral contraceptives, intrauterine contraceptive device, abstemious sexual desire or barrier contraceptive method combined with spermicide) during the study, and sustain contraception 6 months after the last dose
  • Willingness and ability to consent for self to participate in study and comply with scheduled visits, treatment plan, laboratory tests, and other study procedures

Exclusion Criteria:

  • Pregnancy or breastfeeding
  • Prior T-cell therapy
  • Receipt of systemic anticancer therapy or ≥ 5 times the elimination half-life of the drug has elapsed within 2 weeks prior to study treatment (Note: whichever is shorter shall prevail.)
  • Exist ≥ 2 kinds of primary tumor, expect cured preinvasive carcinoma and basaloma. (patients are not excluded if ≥ 5 years treatment with other tumor prior to study treatment.)
  • Autoimmune disease requiring treatment within the past twelve months only requiring related treatment replacement
  • Condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications more than 7 days within 14 days prior to study treatment (Note: inhaled and topical steroids, and adrenal replacement steroid doses > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.)
  • Current treatment on another therapeutic clinical trial within 14 days prior to study treatment
  • Major surgical procedure or significant traumatic injury within 4 weeks prior to study treatment and no date of surgery (if applicable) or anticipated need for a major surgical procedure planned during study treatment
  • Chest radiotherapy ≤ 4 weeks, wide field radiotherapy ≤ 4 weeks (defined as > 50% of volume of pelvic bones or equivalent) or palliative radiotherapy ≤ 2 weeks prior to study treatment
  • Brain involvement with cancer, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease, unless the lesion(s) have been radiated or resected, are considered fully treated and inactive, are asymptomatic, and no steroids have been administered for central nervous system disease over the 2 weeks prior to study treatment
  • Known active viral or nonviral hepatitis or cirrhosis, except patients with Hepatitis C infection and undetectable virus following treatment are eligible.
  • Known human immunodeficiency virus (HIV) positive
  • Ascites or pericardial effusion that can not be control
  • History of or active interstitial lung disease
  • Hypertension is not well controlled by medication. Hypertension defined as blood pressure (BP) systolic > 150 or diastolic > 90 mm Hg (Note: Initiation or adjustment of antihypertensive medication prior to study entry is allowed provided that the average of the three most recent BP readings prior to study enrollment is ≤150/90 mm Hg.)
  • Cardiovascular diseases with clinical significance, include phase II-III cardiac insufficiency defined by New York Heart Association, myocardial infarction (MI) within 3 months prior to study treatment, symptomatic congestive heart failure, cerebral infarction within 3 months prior to study treatment, percutaneous transluminal coronary angioplasty (PTCA), or coronary artery bypass grafting (CABG) within 6 months prior to study treatment
  • Deep-venous thrombosis within 6 months prior to study treatment (except treated without warfarin 2 weeks prior to study treatment)
  • Thrombolytic use (except to maintain IV catheters) within 10 days prior study treatment
  • Any active infection requiring systemic treatment
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for this study

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 identifier (NCT number): NCT04322006

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Contact: Yilong Wu 020-83827812-21187
Contact: Qing Zhou 020-83827812

Show Show 26 study locations
Sponsors and Collaborators
I-Mab Biopharma Co. Ltd.
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Responsible Party: I-Mab Biopharma Co. Ltd. Identifier: NCT04322006    
Other Study ID Numbers: TJ004309STM102
First Posted: March 26, 2020    Key Record Dates
Last Update Posted: March 14, 2023
Last Verified: March 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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