Study of TJ033721 (Givastomig) in Subjects With Advanced or Metastatic Solid Tumors
Condition(s) studied
Investigational drug(s) / intervention(s)
TJ033721 (givastomig): Tetravalent IgG(H)-scFv fusion-type of bi-specific antibody (BsAb)
TJ033721 (givastomig) , nivolumab, chemotherapy: Tetravalent IgG(H)-scFv fusion-type of bi-specific antibody (BsAb), nivolumab, chemotherapy
TJ033721 (givastomig), chemotherapy: Tetravalent IgG(H)-scFv fusion-type of bi-specific antibody (BsAb), chemotherapy
TJ033721 (givastomig), durvalumab, chemotherapy: Tetravalent IgG(H)-scFv fusion-type of bi-specific antibody (BsAb), durvalumab, chemotherapy
Study 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.
Eligibility
Primary outcome measure(s)
- Dose-limiting toxicities (DLTs) — 28 days
- Incidence and severity of AEs — Up to 100 days post last dose
The CTCAE criteria will be used to assess adverse events on this trial. - Maximum tolerated or administered dose (MTD, MAD) — 28 Days
Based on DLT definitions
Trial sites (21)
| Facility | City | Region | Status |
|---|---|---|---|
| Stern Center for Cancer Clinical Trials and Research | Orange | California | Recruiting |
| UCHealth Cancer Care - Anschutz Medical Campus | Aurora | Colorado | Recruiting |
| Horizon Oncology Research, LLC. | Layfayette | Indiana | Completed |
| Mass General Hospital | Boston | Massachusetts | Recruiting |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | Completed |
| NYU Langone | New York | New York | Recruiting |
| Memorial Sloan Kettering Cancer Center | New York | New York | Recruiting |
| Carolina BioOncology Institute | Huntersville | North Carolina | Completed |
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | Completed |
| Mary Crowley Cancer Research | Dallas | Texas | Completed |
| UW Carbone Cancer Center | Madison | Wisconsin | Recruiting |
| The Second Hospital of Anhui Medical University | Hefei | Anhui | Withdrawn |
| Beijing Cancer Hospital | Beijing | Beijing Municipality | Recruiting |
| Sixth Affiliated Hospital, Sun Yat-sen University | Guangzhou | Guangdong | Active Not Recruiting |
| HARBIN Medical University Cancer Hospital | Harbin | Heilongjiang | Completed |
| Henan Cancer Hospital | Zhengzhou | Henan | Completed |
| Hubei Cancer Hospital | Wuhan | Hubei | Completed |
| The First Hospital of China Medical University | Shenyang | Liaoning | Completed |
| Zhongshan Hospital, Fudan University | Shanghai | Shanghai Municipality | Completed |
| Tianjin Medical University Cancer Institute and Hospital | Tianjin | Tianjin Municipality | Completed |
| Sir Run Run Shaw Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | Completed |
More I-Mab Biopharma US Limited trials in the USA
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04900818 on ClinicalTrials.gov ↗ ← All trials in the USA