Trials / Recruiting
RecruitingNCT04900818
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
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 330 (estimated)
- Sponsor
- I-Mab Biopharma US Limited · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2021-06-29
- Primary completion
- 2026-12-01
- Completion
- 2027-12-01
- First posted
- 2021-05-25
- Last updated
- 2026-03-05
Locations
21 sites across 2 countries: United States, China
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04900818. Inclusion in this directory is not an endorsement.