Actively Recruiting
Study of TJ033721 (Givastomig) in Subjects With Advanced or Metastatic Solid Tumors
Led by I-Mab Biopharma US Limited · Updated on 2026-03-05
330
Participants Needed
21
Research Sites
335 weeks
Total Duration
On this page
Sponsors
I
I-Mab Biopharma US Limited
Lead Sponsor
B
Bristol-Myers Squibb
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of TJ033721 (Givastomig) in Subjects With Advanced or Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects with advanced or metastatic solid tumors whose disease has progressed despite standard therapy or who have no further standard options or are unsuitable for available treatments
- Subjects with treatment-naive locally advanced, unresectable or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma
- Subjects with unresectable, locally advanced or metastatic pancreatic adenocarcinoma
- Subjects with unresectable, locally advanced or metastatic biliary tract cancer
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 with adequate organ function
- Known PD-L1 status with prior immunohistochemistry testing and combined positive score (CPS)
- Must have CLDN18.2-positive tumor expression for dose expansion and combination therapy parts
You will not qualify if you...
- Prior exposure to CLDN18.2-targeted therapy
- Prior exposure to 4-1BB agonists
- Second malignancy within the last 3 years except certain skin cancers or cervical carcinoma in situ
- Known active or chronic hepatitis B, hepatitis C, or other hepatitis
- Unstable or active ulcer or digestive tract bleeding within 6 weeks
- Active autoimmune disease requiring systemic treatment within past 2 years
- Active interstitial lung disease (ILD), pneumonitis, or history requiring treatment
- Known active CNS metastases or carcinomatous meningitis; previously treated brain metastases must be stable without steroid use for at least 14 days
- New York Heart Association (NYHA) Class 3 or 4 heart failure, severe angina, recent myocardial infarction, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, arterial embolism, or recent coronary interventions within 6 months
- Diagnosis of immunodeficiency such as active HIV
- Any active infection requiring parenteral treatment
- Prior treatment with anti-PD-1 or PD-L1 agents for combination therapy parts
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 21 locations
1
Stern Center for Cancer Clinical Trials and Research
Orange, California, United States, 92868
Actively Recruiting
2
UCHealth Cancer Care - Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Actively Recruiting
3
Horizon Oncology Research, LLC.
Layfayette, Indiana, United States, 47905
Completed
4
Mass General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
5
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
Completed
6
NYU Langone
New York, New York, United States, 10016
Actively Recruiting
7
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
8
Carolina BioOncology Institute
Huntersville, North Carolina, United States, 28078
Completed
9
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Completed
10
Mary Crowley Cancer Research
Dallas, Texas, United States, 75230
Completed
11
UW Carbone Cancer Center
Madison, Wisconsin, United States, 53705
Actively Recruiting
12
The Second Hospital of Anhui Medical University
Hefei, Anhui, China, 230601
Withdrawn
13
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
14
Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510655
Active, Not Recruiting
15
HARBIN Medical University Cancer Hospital
Harbin, Heilongjiang, China, 150086
Completed
16
Henan Cancer Hospital
Zhengzhou, Henan, China, 45003
Completed
17
Hubei Cancer Hospital
Wuhan, Hubei, China, 430079
Completed
18
The First Hospital of China Medical University
Shenyang, Liaoning, China, 110499
Completed
19
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200032
Completed
20
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China, 300060
Completed
21
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 3110020
Completed
Research Team
C
Clinical Development
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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