A Phase 1 Study of TJ033721 in Subjects With Advanced or Metastatic Solid Tumors

I-Mab Biopharma US Limited

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

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed 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 unresectab…

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

Locations (21)

Stern Center for Cancer Clinical Trials and Research
Orange, California
UCHealth Cancer Care - Anschutz Medical Campus
Aurora, Colorado
Horizon Oncology Research, LLC.
Layfayette, Indiana
Mass General Hospital
Boston, Massachusetts
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey
NYU Langone
New York, New York