Study of TJ011133 in Participants With Relapsed/Refractory Advanced Solid Tumors and Lymphoma
Completed · Phase 1
Conditions studied: Solid Tumor, Lymphoma
In brief
The purpose of this study is to assess the safety and tolerability of TJ011133 in participants with solid tumors and lymphoma.
Key facts
- Study ID
- NCT03934814
- Run by
- I-Mab Biopharma US Limited
- People needed
- 98
- Starts
- 2019-04-16
- Expected to finish
- 2023-01-10
- Last updated by the study team
- 2024-07-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Part 1: Participants with advanced relapsed/refractory solid tumors and lymphoma.
- 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.
You may not qualify if…
- Participants with known symptomatic central nervous system tumors or known central nervous system metastases or leptomeningeal disease requiring steroids. Participants who document stable and central nervous system metastases and are off steroids for more than 4 weeks may be enrolled in the study.
- 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.
Where it is running
- 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
- Henry Ford Cancer Institute/Henry Ford Hospital — Detroit, Michigan, United States
- Mayo Clinic — Rochester, Minnesota, 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
Full record on ClinicalTrials.gov
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