Study of TJ011133 in Participants With Relapsed/Refractory Advanced Solid Tumors and Lymphoma
NCT ID: NCT03934814
Last Updated: 2024-07-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
98 participants
INTERVENTIONAL
2019-04-16
2023-01-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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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).
TJ011133
TJ011133 will be administered weekly.
Part 1B - Combination therapy of TJ011133 with pembrolizumab
TJ011133 will be administered Q1W, starting at 20 mg/ kg, in combination with pembrolizumab.
TJ011133
TJ011133 will be administered weekly.
Pembrolizumab
Pembrolizumab will be administered every 3 weeks.
Part 1C - Combination therapy of TJ011133 with rituximab
TJ011133 will be administered Q1W, starting at 20 mg/kg, in combination with rituximab.
TJ011133
TJ011133 will be administered weekly.
Rituximab
Rituximab will be administered weekly for 5 doses, then followed by monthly doses.
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.
TJ011133
TJ011133 will be administered weekly.
Pembrolizumab
Pembrolizumab will be administered every 3 weeks.
Rituximab
Rituximab will be administered weekly for 5 doses, then followed by monthly doses.
Interventions
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TJ011133
TJ011133 will be administered weekly.
Pembrolizumab
Pembrolizumab will be administered every 3 weeks.
Rituximab
Rituximab will be administered weekly for 5 doses, then followed by monthly doses.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Part 2 with Rituximab: Participants with diffuse large B-cell lymphoma (DLBCL) or Indolent B-cell Lymphoma, with at least one measurable lesion by Lugano and available fresh metastatic biopsy sample prior to study entry.
* Part 2 with Pembrolizumab: Participants with locally advanced non-small-cell lung carcinoma (NSCLC) with disease progression or immune-oncology treatment naive Epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer, with at least one measurable lesion defined by Response Elevation Criteria in Solid Tumors (RECIST) 1.1, and available fresh metastatic biopsy prior to study entry.
* All Parts: Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 1 and adequate bone marrow, renal, and liver functions.
Exclusion Criteria
* Participants with Burkitt's lymphoma, lymphoblastic lymphoma, Richter's transformation, primary effusion lymphoma or chronic lymphocytic leukemia/small lymphocytic lymphoma.
* Participants with mantle cell lymphoma.
* Impaired cardiac function or clinically significant cardiac diseases.
* Prior treatment with CD47 or SIRPα inhibitors.
* Prior autologous stem cell transplant \<=3 months prior to starting study.
* Prior allogeneic stem cell transplant with either standard or reduced intensity conditioning.
* Prior chimeric antigen receptor or chimeric antigen receptor T-cell therapy.
* History of autoimmune anemia or autoimmune thrombocytopenia.
* Positive Direct Antiglobulin Test.
* Active graft versus host disease (GVHD) or ongoing immunosuppression for GVHD.
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
I-Mab Biopharma US Limited
INDUSTRY
Responsible Party
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Locations
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Henry Ford Cancer Institute/Henry Ford Hospital
Detroit, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
University of Alabama - Birmingham
Birmingham, Alabama, United States
Mayo Clinic
Scottsdale, Arizona, United States
Yale School of Medicine
New Haven, Connecticut, United States
Mayo Clinic
Jacksonville, Florida, United States
Horizon Oncology
Lafayette, Indiana, United States
University of Michigan
Ann Arbor, Michigan, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
NYU Langone Health
New York, New York, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
The Fourth Hpspital of Hebei Medical University(Hebei Cancer Hospital)
Shijiazhuang, Hebei, China
Henan Cancer Hospital
Zhengzhou, Henan, China
HuBei Cancer Hospital
Wuhan, Hubei, China
The Second Hospital of Dalian Medical University
Dalian, Liaoning, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Countries
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Other Identifiers
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KEYNOTE A21
Identifier Type: REGISTRY
Identifier Source: secondary_id
MK-3475-A21
Identifier Type: OTHER
Identifier Source: secondary_id
TJ011133EDI101
Identifier Type: -
Identifier Source: org_study_id
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