Clinical Trials /

Safety Study of BJ-001, and IL-15 Fusion Protein, for Locally Advanced/Metastatic Solid Tumors

NCT04294576

Description:

The purpose of this study is to assess the safety and tolerability of BJ-001, a human IL-15 fusion protein, administered via subcutaneous injections, as a single agent and in combination with pembrolizumab administered intravenously at escalating dose levels in adult patients with solid tumors.

Related Conditions:
  • Cholangiocarcinoma
  • Gastric Carcinoma
  • Head and Neck Squamous Cell Carcinoma
  • Malignant Solid Tumor
  • Melanoma
  • Non-Small Cell Lung Carcinoma
  • Pancreatic Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Safety Study of BJ-001, and IL-15 Fusion Protein, for Locally Advanced/Metastatic Solid Tumors
  • Official Title: First-in-human (FIH), Open-Label, Phase 1a (Dose Escalation)/Phase 1b (Expansion Cohorts) Trial of BJ-001 as a Single Agent and in Combination With Pembrolizumab (Keytruda) in Patients With Locally Advanced/Metastatic Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: BJ-001-01-001US
  • NCT ID: NCT04294576

Conditions

  • Locally Advanced/Metastatic Solid Tumors

Interventions

DrugSynonymsArms
BJ-001Arm 1; BJ-001
PembrolizumabArm 2; BJ-001 and Pembrolizumb

Purpose

The purpose of this study is to assess the safety and tolerability of BJ-001, a human IL-15 fusion protein, administered via subcutaneous injections, as a single agent and in combination with pembrolizumab administered intravenously at escalating dose levels in adult patients with solid tumors.

Trial Arms

NameTypeDescriptionInterventions
Arm 1; BJ-001ExperimentalPhase 1a Part 1 and Part 2: dose escalation for BJ-001 as single agent
  • BJ-001
Arm 2; BJ-001 and PembrolizumbExperimentalPhase 1a Part 3: dose escalation for BJ-001 in combination with Pembrolizumab Phase 1b: expansion cohorts for the combination of BJ-001 and Pembrolizumab
  • BJ-001
  • Pembrolizumab

Eligibility Criteria

        Inclusion Criteria:

          -  Phase 1a patients must have locally advanced or metastatic solid tumors,

          -  Phase 1b patients must have locally advanced or metastatic and/or non-resectable head
             and neck squamous cell carcinoma, cholangiocarcinoma, stomach cancer, melanoma,
             pancreatic cancer, NSCLC (as high expression of αVβ3, αVβ5, or αVβ6 have been reported
             for these tumors)

               -  Measurable disease: For Phase 1a patients can have non-measurable or measurable
                  disease. For all other parts: measurable disease defined by RECIST v1.1 is
                  required

               -  For Phase 1a Part 3 and Phase 1b patients (combination treatment) must be
                  refractory or relapsed to anti-PD-1, anti-PD-L1 or anti-CTLA4 checkpoint
                  inhibitors for all tumor types, For Part 1 and Part 2 of Phase 1a (BJ-001 single
                  agent treatment) both checkpoint inhibitor naïve or refractory/relapsed patients
                  will be considered.

          -  Patient who have diagnosis for which treatment with pembrolizumab is approved are
             eligible to be enrolled. Patients previously treated with PD-1/PD-L1 inhibitors and
             who have progressed are eligible.

               -  Adequate hematologic function,

               -  Adequate hepatic function, defined by all of the following:

               -  Adequate renal function defined by estimated creatinine clearance ≥ 45 mL/min
                  (Cockcroft and Gault formula

               -  ECOG Performance Status (PS) of 0-2.

               -  No history of any hematopoietic malignancy.

               -  No active or history of clinically significant autoimmune disease (as defined by
                  previously requiring immunosuppressive therapy).

        Exclusion Criteria:

          -  Pregnant or nursing females.

          -  Receipt of any investigational product or any approved anticancer drug(s) or
             biological product(s) within 4 weeks prior to the first dose of study drug.
             Exceptions: Hormone replacement therapy, testosterone, or oral contraceptives (LHRH
             antagonists are allowed).

          -  Patients previously treated with an anti PD-1/PD-L1 targeting agent who have had any
             prior history of immune-mediated pneumonitis, any immune-mediated toxicity of ≥ Grade
             3,

          -  Patients with a history of severe allergic or anaphylactic reactions to human mAb
             therapy or known hypersensitivity.

          -  Patients with a history of pneumonitis, myocarditis, history of Stevens-Johnson
             syndrome or toxic epidermal necrolysis.

          -  Patients who have undergone a bone marrow transplantation, solid organ
             transplantation, or stem cell transplant.

          -  Patients with unresolved AEs > Grade 1 from prior anticancer therapy.

          -  Patients who have received prior interferon or IL-2 therapy less than 4 weeks prior to
             enrollment.

          -  Uncontrolled primary central nervous system (CNS) tumors or CNS metastases; based on
             screening.

          -  Patients with active autoimmune disease or a documented medical history of autoimmune
             disease managed by replacement therapy.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Frequency of adverse events (AEs) and SAE
Time Frame:90 days after the last dose
Safety Issue:
Description:To assess the safety and tolerability of BJ-001 as a single agent administered s.c. at escalating dose levels in adults with solid tumors.

Secondary Outcome Measures

Measure:Immunogenicity of BJ-001 as a single agent and in combination with pembrolizumab
Time Frame:90 days after last dose
Safety Issue:
Description:The frequency of anti-drug antibodies (ADA) against BJ-001 as a single agent and in combination with pembrolizumab
Measure:Pharmacokinetic (PK) AUC0-τ samples patients treated with BJ-001 as a single agent and in combination with pembrolizumab
Time Frame:24 weeks
Safety Issue:
Description:PK parameters (AUC0-τ) following the first dose and the fourth dose
Measure:Pharmacokinetic (PK) Cmax samples patients treated with BJ-001 as a single agent and in combination with pembrolizumab
Time Frame:24 weeks
Safety Issue:
Description:PK parameters (Cmax) following the first dose and the fourth dose
Measure:Pharmacokinetic (PK) Ctrough samples patients treated with BJ-001 as a single agent and in combination with pembrolizumab
Time Frame:24 weeks
Safety Issue:
Description:PK parameters (Ctrough) following the first dose and the fourth dose
Measure:Pharmacokinetic (PK) Tmax samples patients treated with BJ-001 as a single agent and in combination with pembrolizumab
Time Frame:24 weeks
Safety Issue:
Description:PK parameters (Tmax) following the first dose and the fourth dose

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:BJ Bioscience, Inc.

Trial Keywords

  • FIH
  • Solid Tumors

Last Updated

March 2, 2020