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Clinical Trials Search at Vanderbilt-Ingram Cancer Center

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

The purpose of this study is to assess the safety and tolerability of TJ011133 in participants with solid tumors and lymphoma.
Miscellaneous, Phase I
Phase I
Adults
Mol. targeted/Immunotherapy/Biologics
MK-3475, Pembrolizumab (MK-3475), Rituximab (Rituxan), TJ011133
Berlin, Jordan
National
Vanderbilt University
11-15-2019
Treatment
VICCPHI1944
NCT03934814

Eligibility

18 Years
BOTH
NO
Inclusion Criteria:

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.



Exclusion Criteria:

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 SIRP inhibitors.

Prior autologous stem cell transplant
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.

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