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

Phase 1

Active, not recruiting

• Conditions: Locally Advanced/Metastatic Solid Tumors
• Interventions: Drug: BJ-001; Drug: Pembrolizumab

• Registration Number: NCT04294576
• Lead Sponsor: BJ Bioscience, Inc.

Brief Summary

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 in adult patients with Locally Advanced/Metastatic Solid Tumors

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-04
• Study First Submitted: 2020-02-07
• Study First Submitted QC: 2020-03-02
• Study First Posted: 2020-03-04
• Status Verified: 2023-09
• Last Update Submitted: 2023-11-07
• Last Update Posted: 2023-11-09
• Primary Completion: 2024-04-29
• Study Completion: 2024-10-22

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 92

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 to be enrolled. Patients previously treated with pembrolizumab and who have progressed are eligible. to be enrolled.

  • 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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Arm 1; BJ-001	BJ-001	Phase 1a Part 1, Part 2, and Part 4: dose escalation for BJ-001 as single agent
Arm 2; BJ-001 and pembrolizumab	BJ-001	Phase 1a Part 3 and Part 5: dose escalation for BJ-001 in combination with Pembrolizumab Phase 1b: expansion cohorts for the combination of BJ-001 and pembrolizumab
Arm 2; BJ-001 and pembrolizumab	Pembrolizumab	Phase 1a Part 3 and Part 5: dose escalation for BJ-001 in combination with Pembrolizumab Phase 1b: expansion cohorts for the combination of BJ-001 and pembrolizumab

Primary Outcome Measures

Name	Time	Method
Frequency of adverse events (AEs) and SAE	90 days after the last dose	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.
Severity of AEs in patients with solid tumors enrolled in the study.	From Day 1 of treatment up to 30 days after last dose	To assess the safety and tolerability of s.c. BJ-001 administered at escalating dose levels in combination with Pembrolizumab inhibitor. in adults with solid tumors.
Dose limiting toxicities (DLTs) BJ-001 as a single agent	at the end of week 4 after first dose	To determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of BJ-001 as a single agent.
Dose limiting toxicities (DLTs) BJ-001 in combination with pembrolizumab inhibitor.	at the end of week 4 after first dose	To determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of s.c. BJ-001 administered at escalating dose levels in combination with pembrolizumab in adults with solid tumors.

Secondary Outcome Measures

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

Trial Locations

Locations (5)

Northwest Medical Specialities; 🇺🇸 Tacoma, Washington, United States

Greenville Hospital System University Medical Center (ITOR); 🇺🇸 Greenville, South Carolina, United States

Mount Sinai; 🇺🇸 New York, New York, United States

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States

NEXT Oncology; 🇺🇸 San Antonio, Texas, United States