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Study of TJ033721 in Subjects With Advanced or Metastatic Solid Tumors

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: NCT04900818
Recruitment Status : Recruiting
First Posted : May 25, 2021
Last Update Posted : June 22, 2023
Information provided by (Responsible Party):
I-Mab Biopharma Co. Ltd.

Brief Summary:
This is an open label, multi-center, multiple dose Phase 1 study to evaluate the safety, tolerability, MTD PK, and PD of TJ033721 in subjects with advanced or metastatic solid tumors.

Condition or disease Intervention/treatment Phase
Solid Tumor Advanced Cancer Metastatic Cancer Gastric Cancer Gastroesophageal Junction Carcinoma Esophageal Adenocarcinoma Drug: TJ033721 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of TJ033721 in Subjects With Advanced or Metastatic Solid Tumors
Actual Study Start Date : June 29, 2021
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Dose Escalation: TJ033721

Dose Escalation:: TJ033721 will be administered at up to 8 dose levels (0.1, 0.3, 1, 3, 5, 8, 12 and 15 mg/kg) bi-weekly (Q2W)

During dose expansion, TJ033721 will be administered Q2W, starting at the highest dose to have cleared the DLT period.

After the conclusion of dose expansion TJ033721 will be administered Q2W at the MAD or RP2D.

Drug: TJ033721
Tetravalent IgG(H)-scFv fusion-type of bi-specific antibody (BsAb)

Primary Outcome Measures :
  1. Dose-limiting toxicities (DLTs) [ Time Frame: 28 days ]
  2. Incidence and severity of AEs [ Time Frame: Up to 100 days post last dose ]
    The CTCAE criteria will be used to assess adverse events on this trial.

  3. Maximum tolerated or administered dose (MTD, MAD) [ Time Frame: 28 Days ]
    Based on DLT definitions

Secondary Outcome Measures :
  1. Pharmacokinetic (PK) Parameters: AUC∞ [ Time Frame: Up to 100 days post last dose ]
    Area under the curve from time zero extrapolated to infinity (AUC∞)

  2. Pharmacokinetic (PK) Parameters: AUCt [ Time Frame: up to 100 days post last dose ]
    AUC from time zero to the time of the last quantifiable concentration (AUC0-t)

  3. Pharmacokinetic (PK) Parameters: Cmax [ Time Frame: up to 100 days post last dose ]
    Maximum observed concentration

  4. Pharmacokinetic Parameters: Tmax [ Time Frame: up to 100 days post last dose ]
    Time of peak concentration (Tmax)

  5. Pharmacokinetic Parameters: T1/2 [ Time Frame: up to 100 days post last dose ]
    Investigational Product (IP) half-life (T1/2)

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:

  • Subjects with advanced or metastatic solid tumor in subjects whose disease has progressed despite standard therapy, or who has no further standard therapy, or who is unsuitable for available standard treatment options.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 with adequate organ function
  • Have known PD-L1 status with prior testing by immunohistochemistry and a corresponding combined positive score (CPS)

For dose expansion study only:

  • Advanced or metastatic gastric cancer, gastroesophageal junction carcinoma, and esophageal adenocarcinoma without further standard therapy or unsuitable for available standard treatment options.
  • Must have CLDN18.2-positive tumor expression as determined by the CLDN18.2 IHC assay

Exclusion Criteria

  • Prior exposure to CLDN18.2 -targeted therapy
  • Prior exposure to 4-1BB agonists
  • Second malignancy within the last 3 years with the exception of cutaneous squamous cell carcinoma or cutaneous basal cell carcinoma or cervical carcinoma in situ
  • Known active or chronic Hepatitis B or Hepatitis C, other hepatitides
  • Unstable/active ulcer or digestive tract bleeding within 6 weeks
  • Active autoimmune disease requiring systemic treatment within the past 2 years
  • Active interstitial lung disease (ILD) or pneumonitis or a history of ILD or pneumonitis requiring treatment
  • Known active CNS metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment;
  • New York Heart Association (NYHA) Class 3 or 4 congestive heart failure, severe/unstable angina, myocardial infarction (MI), symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack (TIA), arterial embolism, pulmonary embolism, percutaneous transluminal coronary angioplasty (PTCA), deep vein thrombosis, or coronary artery bypass grafting (CABG) in the previous 6 months
  • Diagnosis of immunodeficiency such as known active HIV
  • Any active infection requiring parenteral treatment

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): NCT04900818

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Contact: US Site Head 301-294-4408

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Sponsors and Collaborators
I-Mab Biopharma Co. Ltd.
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Responsible Party: I-Mab Biopharma Co. Ltd. Identifier: NCT04900818    
Other Study ID Numbers: TJ033721STM101
First Posted: May 25, 2021    Key Record Dates
Last Update Posted: June 22, 2023
Last Verified: June 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplastic Processes
Pathologic Processes