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Study of TJ033721 (Givastomig) in Subjects With Advanced or Metastatic Solid Tumors

NCT04900818 · I-Mab Biopharma US Limited
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Official title
A Phase 1 Study of TJ033721 in Subjects With Advanced or Metastatic Solid Tumors
About this study
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.
Eligibility criteria
Inclusion Criteria: Part 1 - Monotherapy 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; Part 3: Combination Therapy Subjects with unresectable, locally advanced or metastatic histologically confirmed pancreatic adenocarcinoma; Part 4: Combination Therapy Subjects with unresectable, locally advanced or metastatic histologically confirmed biliary tract cancer. * 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 subjects: • Must have CLDN18.2-positive tumor expression Exclusion Criteria * 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. 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, 3, 4 Combination subjects: • Prior treatment with anti-PD-1 or PD-L1 agent
Study design
Enrollment target: 330 participants
Allocation: non_randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2021-06-29
Estimated completion: 2027-12
Last updated: 2026-03-05
Interventions
Drug: TJ033721 (givastomig)Drug: TJ033721 (givastomig) , nivolumab, chemotherapyDrug: TJ033721 (givastomig), chemotherapyDrug: TJ033721 (givastomig), durvalumab, chemotherapy
Primary outcomes
  • Dose-limiting toxicities (DLTs) (28 days)
  • Incidence and severity of AEs (Up to 100 days post last dose)
  • Maximum tolerated or administered dose (MTD, MAD) (28 Days)
Sponsor
I-Mab Biopharma US Limited · industry
With: Bristol-Myers Squibb
Contacts & investigators
ContactClinical Development · contact · us.info@imabbio.com · (240) 745-6330
All locations (21)
Stern Center for Cancer Clinical Trials and ResearchRecruiting
Orange, California, United States
UCHealth Cancer Care - Anschutz Medical CampusRecruiting
Aurora, Colorado, United States
Horizon Oncology Research, LLC.Completed
Layfayette, Indiana, United States
Mass General HospitalRecruiting
Boston, Massachusetts, United States
Rutgers Cancer Institute of New JerseyCompleted
New Brunswick, New Jersey, United States
NYU LangoneRecruiting
New York, New York, United States
Memorial Sloan Kettering Cancer CenterRecruiting
New York, New York, United States
Carolina BioOncology InstituteCompleted
Huntersville, North Carolina, United States
Vanderbilt-Ingram Cancer CenterCompleted
Nashville, Tennessee, United States
Mary Crowley Cancer ResearchCompleted
Dallas, Texas, United States
UW Carbone Cancer CenterRecruiting
Madison, Wisconsin, United States
The Second Hospital of Anhui Medical UniversityWithdrawn
Hefei, Anhui, China
Beijing Cancer HospitalRecruiting
Beijing, Beijing Municipality, China
Sixth Affiliated Hospital, Sun Yat-sen UniversityActive Not Recruiting
Guangzhou, Guangdong, China
HARBIN Medical University Cancer HospitalCompleted
Harbin, Heilongjiang, China
Henan Cancer HospitalCompleted
Zhengzhou, Henan, China
Hubei Cancer HospitalCompleted
Wuhan, Hubei, China
The First Hospital of China Medical UniversityCompleted
Shenyang, Liaoning, China
Zhongshan Hospital, Fudan UniversityCompleted
Shanghai, Shanghai Municipality, China
Tianjin Medical University Cancer Institute and HospitalCompleted
Tianjin, Tianjin Municipality, China
Sir Run Run Shaw Hospital, Zhejiang University School of MedicineCompleted
Hangzhou, Zhejiang, China
Study of TJ033721 (Givastomig) in Subjects With Advanced or Metastatic Solid Tumors · TrialPath