A Study of TJ011133 Subjects with Relapsed/Refractory Advanced Solid Tumors and Lymphoma

Overview

About this study

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

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria: 

  • Part 1:
    • Subjects with advanced relapsed/refractory solid tumors and lymphoma.
  • Part 2 with Rituximab:
    • Subjects with 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:
    • Subject with locally advanced non-small-cell lung carcinoma (NSCLC) with disease progression, Urothelial (bladder) cancer that is not eligible for cisplatin-containing chemotherapy or has progressed following cisplatin-containing chemotherapy, or immune-oncology treatment naive Epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer, with at least one measurable lesion defined by 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: 

  • Subjects with known symptomatic central nervous system tumors or known central nervous system metastases or leptomeningeal disease requiring steroids. Subjects who document stable and central nervous system metastases and are off steroids for more than 4 weeks may be enrolled in the study.
  • Subjects with Burkitt's lymphoma, lymphoblastic lymphoma, Richter's transformation, primary effusion lymphoma or chronic lymphocytic leukemia/small lymphocytic lymphoma.
  • Subjects 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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Winston Tan, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Rochester, Minn.

Mayo Clinic principal investigator

Alex Adjei, M.D., Ph.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Mahesh Seetharam, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions