Study of TJ033721 in Subjects With Advanced or Metastatic Solid Tumors
Study Details
Study Description
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 |
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Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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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)
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Outcome Measures
Primary Outcome Measures
- Dose-limiting toxicities (DLTs) [28 days]
- Incidence and severity of AEs [Up to 100 days post last dose]
The CTCAE criteria will be used to assess adverse events on this trial.
- Maximum tolerated or administered dose (MTD, MAD) [28 Days]
Based on DLT definitions
Secondary Outcome Measures
- Pharmacokinetic (PK) Parameters: AUC∞ [Up to 100 days post last dose]
Area under the curve from time zero extrapolated to infinity (AUC∞)
- Pharmacokinetic (PK) Parameters: AUCt [up to 100 days post last dose]
AUC from time zero to the time of the last quantifiable concentration (AUC0-t)
- Pharmacokinetic (PK) Parameters: Cmax [up to 100 days post last dose]
Maximum observed concentration
- Pharmacokinetic Parameters: Tmax [up to 100 days post last dose]
Time of peak concentration (Tmax)
- Pharmacokinetic Parameters: T1/2 [up to 100 days post last dose]
Investigational Product (IP) half-life (T1/2)
Eligibility Criteria
Criteria
Inclusion Criteria:
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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.
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Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 with adequate organ function
For dose expansion study only:
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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.
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Must have CLDN18.2-positive tumor expression as determined by the CLDN18.2 IHC assay
Exclusion Criteria
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Prior exposure to CLDN18.2 -targeted therapy
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Prior exposure to 4-1BB agonists
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Known active or chronic Hepatitis B or Hepatitis C, other hepatitides
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Unstable/active ulcer or digestive tract bleeding within 6 weeks
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Active autoimmune disease requiring systemic treatment within the past 2 years
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Active interstitial lung disease (ILD) or pneumonitis or a history of ILD or pneumonitis requiring treatment
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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;
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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
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Diagnosis of immunodeficiency such as known active HIV
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Stern Center for Cancer Clinical Trials and Research | Orange | California | United States | 92868 |
2 | UCHealth Cancer Care - Anschutz Medical Campus | Aurora | Colorado | United States | 80045 |
3 | Horizon Oncology Research, LLC. | Lafayette | Indiana | United States | 47905 |
4 | Mass General Hospital | Boston | Massachusetts | United States | 02114 |
5 | Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | United States | 08901 |
6 | Memorial Sloan Kettering Cancer Center | New York | New York | United States | 10065 |
7 | Carolina BioOncology Institute | Huntersville | North Carolina | United States | 28078 |
8 | Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | United States | 37232 |
9 | Mary Crowley Cancer Research | Dallas | Texas | United States | 75230 |
10 | UW Carbone Cancer Center | Madison | Wisconsin | United States | 53705 |
11 | Beijing Cancer Hospital | Beijing | Beijing | China | 100142 |
12 | Sixth Affiliated Hospital, Sun Yat-sen University | Guangzhou | Guangdong | China | 510655 |
13 | Henan Cancer Hospital | Zhengzhou | Henan | China | 45003 |
14 | Hubei Cancer Hospital | Wuhan | Hubei | China | 430079 |
15 | The First Hospital of China Medical University | Shenyang | Liaoning | China | 110499 |
16 | Zhongshan Hospital, Fudan University | Shanghai | Shanghai | China | 200032 |
17 | Tianjin Medical University Cancer Institute and Hospital | Tianjin | Tianjin | China | 300060 |
18 | Sir Run Run Shaw Hospital, Zhejiang University School of Medicine | Hongzhou | Zhejiang | China | 3110020 |
Sponsors and Collaborators
- I-Mab Biopharma Co. Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TJ033721STM101