Study of TJ011133 in Participants With Relapsed/Refractory Advanced Solid Tumors and Lymphoma

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
I-Mab Biopharma US Limited
Study ID
NCT03934814
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • TJ011133 — DRUG
    TJ011133 will be administered weekly.
  • Pembrolizumab — DRUG
    Pembrolizumab will be administered every 3 weeks.
  • Rituximab — DRUG
    Rituximab will be administered weekly for 5 doses, then followed by monthly doses.

Study Details

The purpose of this study is to assess the safety and tolerability of TJ011133 in participants with solid tumors and lymphoma.

Key Dates

Start date
Apr 16, 2019
Status verified
Jun 2024
Primary completion
Jan 10, 2023
Completion
Jan 10, 2023

Study Design

Enrollment
98 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1A - TJ011133 Monotherapy
    TJ011133 alone will be administered at up to 7 dose levels (0.3, 1, 3, 10, 20, 30, 45 mg/kg) once weekly (Q1W) (the 0.3 mg/kg dose level cohort will be enrolled if a DLT in 1 out of 3 subjects is observed following the 1 mg/kg dose level).
  • Experimental: Part 1B - Combination therapy of TJ011133 with pembrolizumab
    TJ011133 will be administered Q1W, starting at 20 mg/ kg, in combination with pembrolizumab.
  • Experimental: Part 1C - Combination therapy of TJ011133 with rituximab
    TJ011133 will be administered Q1W, starting at 20 mg/kg, in combination with rituximab.
  • Experimental: Part 2 - Dose Expansion
    30 participants (with DLBCL or indolent lymphoma) in the TJ011133 combination therapy with rituximab expansion and 20 participants with solid tumors in the TJ011133 combination therapy with pembrolizumab expansion.

Primary Outcome Measure

Dose Limiting Toxicities (DLT) [ Time Frame: 21 or 28 days, depending on study part ]

Locations (12)

FacilityCityStateZIPSite coordinators
University of Alabama - BirminghamBirminghamAlabama35233-
Mayo ClinicScottsdaleArizona85259-
Yale School of MedicineNew HavenConnecticut06510-
Mayo ClinicJacksonvilleFlorida32224-
Horizon OncologyLafayetteIndiana47905-
University of MichiganAnn ArborMichigan48109-
Henry Ford Cancer Institute/Henry Ford HospitalDetroitMichigan48202-
Mayo ClinicRochesterMinnesota55905-
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08901-
NYU Langone HealthNew YorkNew York10016-
Vanderbilt-Ingram Cancer CenterNashvilleTennessee37203-
Seattle Cancer Care AllianceSeattleWashington98109-

Find similar trials in Birmingham, AL

By research site
University of Alabama - Birmingham· Birmingham, ALMayo Clinic· Scottsdale, AZYale School of Medicine· New Haven, CTMayo Clinic· Jacksonville, FLHorizon Oncology· Lafayette, INUniversity of Michigan· Ann Arbor, MI

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