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 PD-1 or PD-L1 Inhibitor in adult patients with Locally Advanced/Metastatic
Solid Tumors
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 Cohort) Trial of BJ-001 as a Single Agent and in Combination With PD-1 or PD-L1 Inhibitor 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
Drug | Synonyms | Arms |
---|
BJ-001 | | Arm 1; BJ-001 |
PD-1 or PD-L1 inhibitor | | Arm 2; BJ-001 and PD-1 or PD-L1 inhibitor |
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 PD-1 or PD-L1 Inhibitor in adult patients with Locally Advanced/Metastatic
Solid Tumors
Trial Arms
Name | Type | Description | Interventions |
---|
Arm 1; BJ-001 | Experimental | Phase 1a Part 1 and Part 2: dose escalation for BJ-001 as single agent | |
Arm 2; BJ-001 and PD-1 or PD-L1 inhibitor | Experimental | Phase 1a Part 3: dose escalation for BJ-001 in combination with an PD-1 or PD-L1 inhibitor. Approximately Phase 1b: expansion cohorts for the combination of BJ-001 and an PD-1 or PD-L1 inhibitor. | - BJ-001
- PD-1 or PD-L1 inhibitor
|
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 PD-1/PD-L1 inhibitors to be
enrolled. Patients previously treated with PD-1/PD-L1 inhibitors 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).
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 PD-1 or PD-L1 inhibitor. |
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 PD-1 or PD-L1 inhibitor. |
Measure: | Pharmacokinetic (PK) AUC0-τ samples patients treated with BJ-001 as a single agent and in combination with PD-1 or PD-L1 inhibitor. |
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 PD-1 or PD-L1 inhibitor. |
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 PD-1 or PD-L1 inhibitor. |
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 PD-1 or PD-L1 inhibitor. |
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
Last Updated
June 26, 2020