Study of TJ011133 Subjects With Relapsed/Refractory Advanced Solid Tumors and Lymphoma
Purpose
The purpose of this study is to assess the safety and tolerability of TJ011133 in participants with solid tumors and lymphoma.
Conditions
- Solid Tumor
- Lymphoma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Sequential Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Part 1A - TJ011133 Monotherapy |
TJ011133 alone will be administered at up to 6 dose levels (0.3, 1, 3, 10, 20, or 30 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 one dose level below MTD or MAD in monotherapy arm, in combination with pembrolizumab |
|
|
Experimental Part 1C -Combination therapy of TJ011133 with rituximab |
TJ011133 will be administered Q1W, starting at one dose level below MTD or MAD in monotherapy arm, in combination with rituximab |
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|
Experimental Part 2 - Dose Expansion |
20 subjects (with DLBCL or indolent lymphoma) in the TJ011133 combination therapy with rituximab expansion and 20 subjects with solid tumors in the TJ011133 combination therapy with pembrolizumab expansion. |
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Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- I-Mab Biopharma Co. Ltd.
Detailed Description
This is an open-label, multi-center, multiple dose, Phase 1 study to evaluate the safety, tolerability, maximum tolerated dose (MTD) or maximum administered dose (MAD), pharmacokinetic (PK), pharmacodynamic, and recommended Phase 2 dose (RP2D) of TJ011133, an anti-CD47 antibody, in subjects with advanced relapsed or refractory solid tumors and lymphoma. The study will be conducted in 2 parts. Part 1 comprises a single agent dose escalation (Part 1A) and 2 separate combination therapy dose escalations (Part 1B with pembrolizumab and Part 1C with rituximab) and Part 2 includes a dose expansion study.