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.
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
Drug | Synonyms | Arms |
---|
TJ033721 | | Dose 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
Name | Type | Description | Interventions |
---|
Dose Escalation: TJ033721 | Experimental | 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. | |
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