Study of TJ033721 (Givastomig) in Subjects With Advanced or Metastatic Solid Tumors
A Phase 1 Study of TJ033721 in Subjects With Advanced or Metastatic Solid Tumors
1 other identifier
interventional
330
2 countries
21
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 (givastomig) in subjects with advanced or metastatic solid tumors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2021
Longer than P75 for phase_1
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 20, 2021
CompletedFirst Posted
Study publicly available on registry
May 25, 2021
CompletedStudy Start
First participant enrolled
June 29, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
March 5, 2026
March 1, 2026
5.4 years
May 20, 2021
March 3, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
Dose-limiting toxicities (DLTs)
28 days
Incidence and severity of AEs
The CTCAE criteria will be used to assess adverse events on this trial.
Up to 100 days post last dose
Maximum tolerated or administered dose (MTD, MAD)
Based on DLT definitions
28 Days
Secondary Outcomes (5)
Pharmacokinetic (PK) Parameters: AUC∞
Up to 100 days post last dose
Pharmacokinetic (PK) Parameters: AUCt
up to 100 days post last dose
Pharmacokinetic (PK) Parameters: Cmax
up to 100 days post last dose
Pharmacokinetic Parameters: Tmax
up to 100 days post last dose
Pharmacokinetic Parameters: T1/2
up to 100 days post last dose
Study Arms (4)
TJ033721 (givastomig)
EXPERIMENTALDose 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) in combination with nivolumab and chemotherapy
EXPERIMENTALTJ033721 will be administered in combination with nivolumab and chemotherapy
TJ033721 (givastomig) in combination chemotherapy
EXPERIMENTALTJ033721 (givastomig) will be administered in combination chemotherapy
TJ033721 (givastomig) in combination with durvalumab and chemotherapy
EXPERIMENTALTJ033721 (givastomig) will be administered in combination with durvalumab and chemotherapy
Interventions
Tetravalent IgG(H)-scFv fusion-type of bi-specific antibody (BsAb), nivolumab, chemotherapy
Tetravalent IgG(H)-scFv fusion-type of bi-specific antibody (BsAb)
Tetravalent IgG(H)-scFv fusion-type of bi-specific antibody (BsAb), chemotherapy
Tetravalent IgG(H)-scFv fusion-type of bi-specific antibody (BsAb), durvalumab, chemotherapy
Eligibility Criteria
You may qualify if:
- 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
You may not qualify 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 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- I-Mab Biopharma US Limitedlead
- Bristol-Myers Squibbcollaborator
Study Sites (21)
Stern Center for Cancer Clinical Trials and Research
Orange, California, 92868, United States
UCHealth Cancer Care - Anschutz Medical Campus
Aurora, Colorado, 80045, United States
Horizon Oncology Research, LLC.
Layfayette, Indiana, 47905, United States
Mass General Hospital
Boston, Massachusetts, 02114, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901, United States
NYU Langone
New York, New York, 10016, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Carolina BioOncology Institute
Huntersville, North Carolina, 28078, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232, United States
Mary Crowley Cancer Research
Dallas, Texas, 75230, United States
UW Carbone Cancer Center
Madison, Wisconsin, 53705, United States
The Second Hospital of Anhui Medical University
Hefei, Anhui, 230601, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510655, China
HARBIN Medical University Cancer Hospital
Harbin, Heilongjiang, 150086, China
Henan Cancer Hospital
Zhengzhou, Henan, 45003, China
Hubei Cancer Hospital
Wuhan, Hubei, 430079, China
The First Hospital of China Medical University
Shenyang, Liaoning, 110499, China
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 3110020, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 20, 2021
First Posted
May 25, 2021
Study Start
June 29, 2021
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2027
Last Updated
March 5, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share