Purpose

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

Conditions

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

ArmDescriptionAssigned 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)
  • Drug: TJ011133
    TJ011133 will be administered weekly
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
  • Drug: TJ011133
    TJ011133 will be administered weekly
  • Drug: Pembrolizumab
    Pembrolizumab will be administered every 3 weeks
    Other names:
    • Keytruda
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
  • Drug: TJ011133
    TJ011133 will be administered weekly
  • Drug: Rituximab
    Rituximab will be administered weekly for 5 doses, then followed by monthly doses
    Other names:
    • Rituxan, MabThera
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.
  • Drug: TJ011133
    TJ011133 will be administered weekly
  • Drug: Pembrolizumab
    Pembrolizumab will be administered every 3 weeks
    Other names:
    • Keytruda
  • Drug: Rituximab
    Rituximab will be administered weekly for 5 doses, then followed by monthly doses
    Other names:
    • Rituxan, MabThera

Recruiting Locations

University of Alabama - Birmingham
Birmingham, Alabama 35233
Contact:
Dayle Craig
dc0350@uab.edu

More Details

Status
Recruiting
Sponsor
I-Mab Biopharma Co. Ltd.

Study Contact

US Site Head
301-294-4408
us.info@i-mabbiopharma.com

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.