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Cytokine Therapy
BJ-001 + Pembrolizumab for Advanced Cancer (FIH Trial)
Phase 1
Waitlist Available
Research Sponsored by BJ Bioscience, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Phase 1a patients must have locally advanced or metastatic solid tumors
No active or history of clinically significant autoimmune disease (as defined by previously requiring immunosuppressive therapy)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from day 1 of treatment up to 30 days after last dose
Awards & highlights
FIH Trial Summary
This trial is testing a new drug, BJ-001, to see if it is safe and effective when used alone or with another drug, pembrolizumab, to treat adults with solid tumors that have spread.
Who is the study for?
This trial is for adults with advanced solid tumors who have measurable disease, proper liver and kidney function, and a performance status indicating they can care for themselves. They must not have had certain prior treatments or severe allergies to monoclonal antibodies. Some patients must be unresponsive to specific cancer immunotherapies.Check my eligibility
What is being tested?
The study tests BJ-001, an IL-15 fusion protein given by injection alone or with pembrolizumab (an existing cancer drug), in patients with advanced solid tumors. It aims to find out how safe and tolerable this combination is.See study design
What are the potential side effects?
Potential side effects may include reactions at the injection site, immune system-related issues such as inflammation of organs due to overactivation of the immune response, fatigue, allergic reactions similar to those seen with other monoclonal antibody therapies.
FIH Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has spread beyond its original location.
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I have never needed treatment for a serious autoimmune disease.
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My liver is functioning well.
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I am able to care for myself and perform daily activities.
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My kidneys work well enough, with a creatinine clearance rate of at least 45 mL/min.
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I have advanced or inoperable cancer in specific areas with certain protein expressions.
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I have never had blood cancer.
FIH Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from day 1 of treatment up to 30 days after last dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from day 1 of treatment up to 30 days after last dose
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose limiting toxicities (DLTs) BJ-001 as a single agent
Dose limiting toxicities (DLTs) BJ-001 in combination with pembrolizumab inhibitor.
Frequency of adverse events (AEs) and SAE
+1 moreSecondary outcome measures
Immunogenicity of 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.
Pharmacokinetic (PK) Cmax samples patients treated with BJ-001 as a single agent and in combination with Pembrolizumab.
+2 moreFIH Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm 2; BJ-001 and pembrolizumabExperimental Treatment2 Interventions
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
Group II: Arm 1; BJ-001Experimental Treatment1 Intervention
Phase 1a Part 1, Part 2, and Part 4: dose escalation for BJ-001 as single agent
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCIndustry Sponsor
3,886 Previous Clinical Trials
5,054,461 Total Patients Enrolled
BJ Bioscience, Inc.Lead Sponsor
1 Previous Clinical Trials
85 Total Patients Enrolled
Iqvia Pty LtdIndustry Sponsor
106 Previous Clinical Trials
169,916 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has spread beyond its original location.My cancer can be measured by standard health scans.I have never needed treatment for a serious autoimmune disease.I've had severe side effects from previous immunotherapy.My liver is functioning well.I have tried immunotherapy without success or have never had it.I have side effects from cancer treatment that are not severe.My blood counts are within a healthy range.I have been diagnosed with a condition that requires pembrolizumab treatment, even if I've previously used it without success.I haven't taken any experimental or cancer drugs in the last 4 weeks, except for hormone therapy or contraceptives.You have experienced severe allergic reactions in the past to a type of treatment called human mAb therapy, or you have known hypersensitivity.I have had a bone marrow, solid organ, or stem cell transplant.I am able to care for myself and perform daily activities.My kidneys work well enough, with a creatinine clearance rate of at least 45 mL/min.I have advanced or inoperable cancer in specific areas with certain protein expressions.I have never had blood cancer.I haven't had interferon or IL-2 therapy in the last 4 weeks.I do not have uncontrolled brain tumors or cancer spread to the brain.You have had lung inflammation (pneumonitis), heart inflammation (myocarditis), or have had a serious skin reaction called Stevens-Johnson syndrome or toxic epidermal necrolysis in the past.I have an autoimmune disease that is either active or managed by replacement therapy.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 2; BJ-001 and pembrolizumab
- Group 2: Arm 1; BJ-001
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current capacity of participants for this clinical trial?
"Affirmative. An inspection of clinicaltrials.gov reveals that recruitment is ongoing for this medical study, which was first publicized on December 4th 2019 and revised on June 5th 2022. 92 patients are needed at five different sites to complete the trial."
Answered by AI
What adverse effects are associated with BJ-001?
"Given the limited clinical data regarding BJ-001's efficacy and safety, our team at Power rated it a 1 on their scale."
Answered by AI
What goals is this research endeavor attempting to achieve?
"The primary objective of this medical trial, which is set to conclude after 4 weeks from the first dose, is to monitor adverse events (AEs) and serious adverse events (SAEs). Secondary objectives include measuring pharmacokinetic Cmax and AUC0-τ levels following initial dosing as well as investigating immunogenicity of BJ-001 in combination with PD-1 or PDL-1 inhibitors."
Answered by AI
Are there ample sites conducting this clinical experiment across the U.S.?
"To participate in this trial, patients can visit Greenville Hospital System University Medical Center (ITOR) in Greenville, Washington University School of Medicine in Saint Louis and Mount Sinai in New york. Additionally, there are 5 other sites recruiting participants for the study."
Answered by AI
Can any additional participants be enrolled in this experiment?
"Correct. The clinicaltrials.gov database verifies that this scientific experiment, which was initially published on December 4th 2019, is presently enrolling participants. Approximately 92 individuals need to be recruited from 5 distinct medical centres."
Answered by AI
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