Study of TJ033721 (Givastomig) in Subjects With Advanced or Metastatic Solid Tumors
NCT04900818 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 330
Last updated 2026-03-05
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.
Conditions
- Solid Tumor
- Advanced Cancer
- Metastatic Cancer
- Gastric Cancer
- Gastroesophageal Junction Carcinoma
- Esophageal Adenocarcinoma
- PDAC - Pancreatic Ductal Adenocarcinoma
- Biliary Tract Cancer (BTC)
Interventions
- DRUG
-
TJ033721 (givastomig)
Tetravalent IgG(H)-scFv fusion-type of bi-specific antibody (BsAb)
- DRUG
-
TJ033721 (givastomig) , nivolumab, chemotherapy
Tetravalent IgG(H)-scFv fusion-type of bi-specific antibody (BsAb), nivolumab, chemotherapy
- DRUG
-
TJ033721 (givastomig), chemotherapy
Tetravalent IgG(H)-scFv fusion-type of bi-specific antibody (BsAb), chemotherapy
- DRUG
-
TJ033721 (givastomig), durvalumab, chemotherapy
Tetravalent IgG(H)-scFv fusion-type of bi-specific antibody (BsAb), durvalumab, chemotherapy
Sponsors & Collaborators
- collaborator INDUSTRY
-
I-Mab Biopharma US Limited
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-06-29
- Primary Completion
- 2026-12-31
- Completion
- 2027-12-31
- FDA Drug
- Yes
Countries
- United States
- China
Study Locations
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