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New treatment option for Solid Tumor
Official title Study of TJ033721 (Givastomig) in Subjects With Advanced or Metastatic Solid Tumors
ClinicalTrials.gov ID: NCT04900818
What this study is testing
What is TJ033721 (givastomig)?
TJ033721 (givastomig) is an investigational medicine, being studied as a potential treatment for solid tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is an open label, multi-center, multiple dose Phase 1 study to evaluate the safety, tolerability, MTD PK, and PD of TJ033721 (givastomig) in subjects with advanced or metastatic solid tumors.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Part 1 - Monotherapy people with advanced or metastatic solid tumor in people whose disease has progressed despite standard therapy, or who has no...
- 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...
- Must have CLDN18.2-positive tumor expression
You likely can't join if
- 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...
- 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
See the full eligibility criteria
- Part 1 - Monotherapy people with advanced or metastatic solid tumor in people whose disease has progressed despite standard therapy, or who has no further standard therapy, or who is unsuitable for available standard...
- 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, Part 3, Part 4 Combination people:
- Must have CLDN18.2-positive tumor expression
- 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. people with previously treated brain metastases may participate provided they are clinically stable and without requirement of steroid treatment for at least...
- 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...
- Diagnosis of immunodeficiency such as known active HIV
- Any active infection requiring parenteral treatment For Part 2, 3, 4 Combination people:
- Prior treatment with anti-PD-1 or PD-L1 agent
The study team makes the final eligibility decision.
Where it's taking place
- Orange, California, United States
- Aurora, Colorado, United States
- Layfayette, Indiana, United States
- Boston, Massachusetts, United States
- New Brunswick, New Jersey, United States
- New York, New York, United States
- Huntersville, North Carolina, United States
- Nashville, Tennessee, United States
- Dallas, Texas, United States
- Madison, Wisconsin, United States
- Hefei, Anhui, China
- Beijing, Beijing Municipality, China
- Guangzhou, Guangdong, China
- Harbin, Heilongjiang, China
- Zhengzhou, Henan, China
- Wuhan, Hubei, China
- Shenyang, Liaoning, China
- Shanghai, Shanghai Municipality, China
- Tianjin, Tianjin Municipality, China
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Orange, California, United States; Aurora, Colorado, United States; Layfayette, Indiana, United States; Boston, Massachusetts, United States; New Brunswick, New Jersey, United States; New York, New York, United States and 14 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.