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

Status: Recruiting
Location: See all (21) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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;

• 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 Combination subjects:

⁃ • Must have CLDN18.2-positive tumor expression

Locations
United States
California
Stern Center for Cancer Clinical Trials and Research
RECRUITING
Orange
Colorado
UCHealth Cancer Care - Anschutz Medical Campus
RECRUITING
Aurora
Indiana
Horizon Oncology Research, LLC.
COMPLETED
Layfayette
Massachusetts
Mass General Hospital
RECRUITING
Boston
North Carolina
Carolina BioOncology Institute
COMPLETED
Huntersville
New Jersey
Rutgers Cancer Institute of New Jersey
ACTIVE_NOT_RECRUITING
New Brunswick
New York
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
NYU Langone
RECRUITING
New York
Tennessee
Vanderbilt-Ingram Cancer Center
RECRUITING
Nashville
Texas
Mary Crowley Cancer Research
COMPLETED
Dallas
Wisconsin
UW Carbone Cancer Center
RECRUITING
Madison
Other Locations
China
Beijing Cancer Hospital
RECRUITING
Beijing
Sixth Affiliated Hospital, Sun Yat-sen University
RECRUITING
Guangzhou
HARBIN Medical University Cancer Hospital
NOT_YET_RECRUITING
Harbin
The Second Hospital of Anhui Medical University
NOT_YET_RECRUITING
Hefei
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
RECRUITING
Hongzhou
Zhongshan Hospital, Fudan University
RECRUITING
Shanghai
The First Hospital of China Medical University
RECRUITING
Shenyang
Tianjin Medical University Cancer Institute and Hospital
RECRUITING
Tianjin
Hubei Cancer Hospital
RECRUITING
Wuhan
Henan Cancer Hospital
NOT_YET_RECRUITING
Zhengzhou
Contact Information
Primary
US Site Head
us.info@i-mabbiopharma.com
301-294-4408
Time Frame
Start Date: 2021-06-29
Estimated Completion Date: 2026-12
Participants
Target number of participants: 168
Treatments
Experimental: TJ033721 (givastomig)
Dose 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.
Experimental: TJ033721 (givastomig) in combination with nivolumab and chemotherapy
TJ033721 will be administered in combination with nivolumab and chemotherapy
Related Therapeutic Areas
Sponsors
Collaborators: Bristol-Myers Squibb
Leads: I-Mab Biopharma US Limited

This content was sourced from clinicaltrials.gov

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