Study of TJ033721 (givastomig) in Subjects with Advanced or Metastatic Solid Tumors
NCT ID: NCT04900818
Last Updated: 2025-01-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
168 participants
INTERVENTIONAL
2021-06-29
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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TJ033721 (givastomig)
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) and 1 dose level (18 mg/kg) every 3 weeks (Q3W)
During dose expansion, TJ033721 will be administered Q2W, starting at the RP2D or MTD in dose escalation.
TJ033721 (givastomig)
Tetravalent IgG(H)-scFv fusion-type of bi-specific antibody (BsAb)
TJ033721 (givastomig) in combination with nivolumab and chemotherapy
TJ033721 will be administered in combination with nivolumab and chemotherapy
TJ033721 (givastomig) , nivolumab, chemotherapy
Tetravalent IgG(H)-scFv fusion-type of bi-specific antibody (BsAb), nivolumab, chemotherapy
Interventions
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TJ033721 (givastomig)
Tetravalent IgG(H)-scFv fusion-type of bi-specific antibody (BsAb)
TJ033721 (givastomig) , nivolumab, chemotherapy
Tetravalent IgG(H)-scFv fusion-type of bi-specific antibody (BsAb), nivolumab, chemotherapy
Eligibility Criteria
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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.
Part 2 - Combination Therapy Subjects with treatment naïve locally advanced, unresectable or metastatic gastric, GEJ, esophageal adenocarcinoma;
* 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 and Part 2 Combination subjects:
• Must have CLDN18.2-positive tumor expression
Exclusion Criteria
* 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, percutaneous transluminal coronary angioplasty (PTCA), 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
For Part 2 Combination subjects:
• Prior treatment with anti-PD-1 or PD-L1
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
I-Mab Biopharma US Limited
INDUSTRY
Responsible Party
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Locations
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Stern Center for Cancer Clinical Trials and Research
Orange, California, United States
UCHealth Cancer Care - Anschutz Medical Campus
Aurora, Colorado, United States
Horizon Oncology Research, LLC.
Layfayette, Indiana, United States
Mass General Hospital
Boston, Massachusetts, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
NYU Langone
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Carolina BioOncology Institute
Huntersville, North Carolina, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Mary Crowley Cancer Research
Dallas, Texas, United States
UW Carbone Cancer Center
Madison, Wisconsin, United States
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
HARBIN Medical University Cancer Hospital
Harbin, Heilongjiang, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Hubei Cancer Hospital
Wuhan, Hubei, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hongzhou, Zhejiang, China
Countries
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Central Contacts
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Other Identifiers
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TJ033721STM101
Identifier Type: -
Identifier Source: org_study_id
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