Clinical Trials /

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

NCT03934814

Description:

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

Related Conditions:
  • B-Cell Non-Hodgkin Lymphoma
  • Bladder Carcinoma
  • Diffuse Large B-Cell Lymphoma
  • Fallopian Tube Carcinoma
  • Lymphoma
  • Malignant Ovarian Epithelial Tumor
  • Malignant Solid Tumor
  • Non-Small Cell Lung Carcinoma
  • Primary Peritoneal Carcinoma
  • Urothelial Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Study of TJ011133 Subjects With Relapsed/Refractory Advanced Solid Tumors and Lymphoma
  • Official Title: A Phase 1 Study of TJ011133 Administered Alone or in Combination With Pembrolizumab or Rituximab in Subjects With Relapsed/Refractory Advanced Solid Tumors and Lymphoma

Clinical Trial IDs

  • ORG STUDY ID: TJ011133EDI101
  • NCT ID: NCT03934814

Conditions

  • Solid Tumor
  • Lymphoma

Interventions

DrugSynonymsArms
TJ011133Part 1A - TJ011133 Monotherapy
PembrolizumabKeytrudaPart 1B - Combination therapy of TJ011133 with pembrolizumab
RituximabRituxan, MabTheraPart 1C -Combination therapy of TJ011133 with rituximab

Purpose

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

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 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.
    

Trial Arms

NameTypeDescriptionInterventions
Part 1A - TJ011133 MonotherapyExperimentalTJ011133 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)
  • TJ011133
Part 1B - Combination therapy of TJ011133 with pembrolizumabExperimentalTJ011133 will be administered Q1W, starting at one dose level below MTD or MAD in monotherapy arm, in combination with pembrolizumab
  • TJ011133
  • Pembrolizumab
Part 1C -Combination therapy of TJ011133 with rituximabExperimentalTJ011133 will be administered Q1W, starting at one dose level below MTD or MAD in monotherapy arm, in combination with rituximab
  • TJ011133
  • Rituximab
Part 2 - Dose ExpansionExperimental20 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.
  • TJ011133
  • Pembrolizumab
  • Rituximab

Eligibility Criteria

        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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Dose Limiting Toxicities (DLT)
Time Frame:21 or 28 days, depending on Study Part
Safety Issue:
Description:Part 1A DLT period is 3 weeks, Part 1B DLT period is 3 weeks, Part 1C DLT period is 4 weeks

Secondary Outcome Measures

Measure:Pharmacokinetic Parameters: Tmax
Time Frame:up to 100 days post last dose
Safety Issue:
Description:Time of peak concentration (Tmax)
Measure:Pharmacokinetic Parameters: Cmax
Time Frame:up to 100 days post last dose
Safety Issue:
Description:Maximal concentration (Cmax)
Measure:Pharmacokinetic Parameters: T1/2
Time Frame:up to 100 days post last dose
Safety Issue:
Description:Investigational Product (IP) half-life (T1/2)
Measure:Pharmacokinetic Parameters: CL
Time Frame:up to 100 days post last dose
Safety Issue:
Description:Investigational Product (IP) Clearance (CL)
Measure:Pharmacokinetic (PK) Parameters: AUC∞
Time Frame:up to 100 days post last dose
Safety Issue:
Description:Area under the curve from time zero extrapolated to infinity (AUC∞)
Measure:Anti-drug antibodies (ADA)
Time Frame:up to 100 days post last dose
Safety Issue:
Description:Incidence and concentration of anti-drug antibodies

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:I-Mab Biopharma Co. Ltd.

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