A Phase I Study of TJ033721 in Subjects with Advanced or Metastatic Solid Tumors.
The primary objectives of the study are:
1. to evaluate the safety and tolerability of TJ033721 in subjects with advanced or metastatic solid tumors;
2. to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) of TJ033721;
3. to determine a recommended phase 2 dose (RP2D) of TJ033721.
The secondary objectives of the study are:
1. to characterize the pharmacokinetic (PK) profile of TJ033721;
2. to evaluate pharmacodynamic (PD) profiling of TJ033721;
3. to evaluate the immunogenicity of TJ033721;
4. to assess preliminary antitumor activity of TJ033721 by assessing response rate by RECIST 1.1 and iRECIST.
The exploratory objectives of the study are:
1. to explore associations of PD activity with efficacy and safety outcomes in subjects treated with TJ033721;
2. to explore the exposure-response relationship for PD activity in subjects treated with TJ033721;
3. to explore associations of exploratory biomarkers with PD activity in subjects treated with TJ033721.
- Rutgers Cancer Institute of New Jersey
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
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
For further information about clinical trials, please contact us at 732-235-7356.