Clinical Trials /

Study of TJ011133 in Participants 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
  • Diffuse Large B-Cell Lymphoma
  • Fallopian Tube Carcinoma
  • Lymphoma
  • Malignant Ovarian Epithelial Tumor
  • Malignant Solid Tumor
  • Non-Small Cell Lung Carcinoma
  • Primary Peritoneal Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Study of TJ011133 in Participants 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
  • SECONDARY ID: KEYNOTE KN-A21
  • 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, an
      anti-CD47 antibody, in participants 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 7 dose levels (0.3, 1, 3, 10, 20, 30, 45 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 20 mg/ kg, in combination with pembrolizumab.
  • TJ011133
  • Pembrolizumab
Part 1C - Combination therapy of TJ011133 with rituximabExperimentalTJ011133 will be administered Q1W, starting at 20 mg/kg, in combination with rituximab.
  • TJ011133
  • Rituximab
Part 2 - Dose ExpansionExperimental30 participants (with DLBCL or indolent lymphoma) in the TJ011133 combination therapy with rituximab expansion and 20 participants with solid tumors in the TJ011133 combination therapy with pembrolizumab expansion.
  • TJ011133
  • Pembrolizumab
  • Rituximab

Eligibility Criteria

        Inclusion Criteria:

          -  Part 1: Participants with advanced relapsed/refractory solid tumors and lymphoma.

          -  Part 2 with Rituximab: Participants 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: 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 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 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:Recruiting
Lead Sponsor:AbbVie

Trial Keywords

  • Solid Tumor
  • Lymphoma

Last Updated

June 30, 2021