Clinical Trials /

Study of TJ033721 in Subjects With Advanced or Metastatic Solid Tumors

NCT04900818

Description:

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.

Related Conditions:
  • Adenocarcinoma of the Gastroesophageal Junction
  • Esophageal Adenocarcinoma
  • Gastric Carcinoma
  • Malignant Solid Tumor
  • Pancreatic Ductal Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Study of TJ033721 in Subjects With Advanced or Metastatic Solid Tumors
  • Official Title: A Phase 1 Study of TJ033721 in Subjects With Advanced or Metastatic Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: TJ033721STM101
  • NCT ID: NCT04900818

Conditions

  • Solid Tumor
  • Advanced Cancer
  • Metastatic Cancer
  • Gastric Cancer
  • Gastroesophageal Junction Carcinoma
  • Esophageal Adenocarcinoma
  • Pancreatic Ductal Adenocarcinoma

Interventions

DrugSynonymsArms
TJ033721Dose Escalation: TJ033721

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Dose Escalation: TJ033721ExperimentalDose 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.
  • TJ033721

Eligibility Criteria

        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

        For dose expansion study only:

          -  Advanced or metastatic gastric cancer, gastroesophageal junction carcinoma, esophageal
             adenocarcinoma, and pancreatic ductal 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

          -  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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Dose-limiting toxicities (DLTs)
Time Frame:28 days
Safety Issue:
Description:The CTCAE criteria will be used to assess adverse events on this trial.

Secondary Outcome Measures

Measure:Pharmacokinetic (PK) Parameters: AUC∞
Time Frame:Up to 100 days post last dose
Safety Issue:
Description:Area under the curve from time zero extrapolated to infinity (AUC∞)
Measure:Pharmacokinetic (PK) Parameters: AUCt
Time Frame:up to 100 days post last dose
Safety Issue:
Description:AUC from time zero to the time of the last quantifiable concentration (AUC0-t)
Measure:Pharmacokinetic (PK) Parameters: Cmax
Time Frame:up to 100 days post last dose
Safety Issue:
Description:Maximum observed concentration
Measure:Pharmacokinetic Parameters: Tmax
Time Frame:up to 100 days post last dose
Safety Issue:
Description:Time of peak concentration (Tmax)
Measure:Pharmacokinetic Parameters: T1/2
Time Frame:up to 100 days post last dose
Safety Issue:
Description:Investigational Product (IP) half-life (T1/2)

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:I-Mab Biopharma Co. Ltd.

Last Updated

July 22, 2021