Study of TJ033721 (Givastomig) in Subjects With Advanced or Metastatic Solid Tumors

Part of paid clinical trials in Orange, California.

Sponsor
I-Mab Biopharma US Limited
Study ID
NCT04900818
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Advanced Cancer
  • Biliary Tract Cancer (BTC)
  • Esophageal Adenocarcinoma
  • Gastric Cancer
  • Gastroesophageal Junction Carcinoma
  • Metastatic Cancer
  • PDAC - Pancreatic Ductal Adenocarcinoma
  • Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Jun 29, 2021
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
330 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • 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
  • Experimental: TJ033721 (givastomig) in combination chemotherapy
    TJ033721 (givastomig) will be administered in combination chemotherapy
  • Experimental: TJ033721 (givastomig) in combination with durvalumab and chemotherapy
    TJ033721 (givastomig) will be administered in combination with durvalumab and chemotherapy

Primary Outcome Measure

Dose-limiting toxicities (DLTs) [ Time Frame: 28 days ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
Stern Center for Cancer Clinical Trials and ResearchOrangeCalifornia92868-
UCHealth Cancer Care - Anschutz Medical CampusAuroraColorado80045-
Horizon Oncology Research, LLC.LayfayetteIndiana47905-
Mass General HospitalBostonMassachusetts02114-
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08901-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
NYU LangoneNew YorkNew York10016-
Carolina BioOncology InstituteHuntersvilleNorth Carolina28078-
Vanderbilt-Ingram Cancer CenterNashvilleTennessee37232-
Mary Crowley Cancer ResearchDallasTexas75230-
UW Carbone Cancer CenterMadisonWisconsin53705-

Find similar trials in Orange, CA

By condition
Gastric cancer
By specialty
OncologyGI oncology
By research site
Stern Center for Cancer Clinical Trials and Research· Orange, CAUCHealth Cancer Care - Anschutz Medical Campus· Aurora, COHorizon Oncology Research, LLC.· Layfayette, INMass General Hospital· Boston, MARutgers Cancer Institute of New Jersey· New Brunswick, NJMemorial Sloan Kettering Cancer Center· New York, NY

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