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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age: ≥18 years
Has documented locally advanced or metastatic NSCLC, not amenable to curative surgery or radiation with documentation of radiological disease progression while on/after receiving most recent treatment regimen for locally advanced or metastatic disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year
Awards & highlights
Study Summary
This trial tests a new drug to treat lung cancer that has spread or is hard to remove.
Who is the study for?
Adults over 18 with advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) that can't be removed by surgery, who've seen their cancer progress after treatment. They must have a life expectancy of at least 3 months, be in fairly good health otherwise (ECOG PS 0-1), and have a tumor that can be measured. People with autoimmune diseases, mixed lung cancers, recent other treatments or another cancer within the last 5 years, serious infections or heart disease aren't eligible.Check my eligibility
What is being tested?
The trial is testing BL-B01D1's safety and effectiveness for NSCLC patients whose cancer has spread and cannot be surgically removed. The study will monitor how well patients tolerate this drug and its impact on their lung cancer.See study design
What are the potential side effects?
While specific side effects for BL-B01D1 are not listed here, common ones for similar drugs include allergic reactions to the drug components, potential worsening of pre-existing conditions like heart or lung disease, fatigue, nausea, and increased risk of infection.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
My advanced lung cancer cannot be cured with surgery or radiation, and it has worsened despite treatment.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Participants with Dose-limiting toxicities
Participants with Serious Adverse Events (SAEs) and treatment-emergent adverse events (TEAEs)
Participants with ability to care for themselves, daily activity, and physical activity
+4 moreSecondary outcome measures
AUC(0-8) of BL-B01D1
AUC(0-8) of anti-EGFR×HER3 antibodies
AUC(0-8) of free payload ED-04
+14 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: BL-B01D1 administered Day 1 per cycleExperimental Treatment1 Intervention
BL-B01D1 will be administered on Day 1 via by intravenous infusion every 3 weeks
Group II: BL-B01D1 administered Day 1 and Day 8 per cycleExperimental Treatment1 Intervention
BL-B01D1 will be administered on Day 1 and Day 8 by intravenous infusion every 3 weeks
Find a Location
Who is running the clinical trial?
SystImmune Inc.Lead Sponsor
20 Previous Clinical Trials
1,272 Total Patients Enrolled
Clinical LeaderStudy DirectorSystImmune Inc.
3 Previous Clinical Trials
531 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an active autoimmune or inflammatory disease.You have at least one identifiable abnormality that can be measured according to specific guidelines.I have severe lung disease or a history of tissue scarring in my lungs.I am 18 years old or older.My advanced lung cancer cannot be cured with surgery or radiation, and it has worsened despite treatment.I haven't had serious blood clot issues needing treatment in the last 6 months.I was diagnosed with another cancer within the last 5 years.I am currently being treated for an active infection.I have a history of severe heart disease.I do not have active HIV, tuberculosis, Hepatitis B, or Hepatitis C.You are expected to live for at least 3 more months.I have had a stem cell transplant using my own or donor cells.I am fully active or restricted in physically strenuous activity but can do light work.My high blood pressure is not well-managed.I have symptoms from cancer spread to my brain.My lung cancer is a mix of small-cell and non-small cell types.I haven't had cancer treatments like chemotherapy or surgery in the last 4 weeks.You have had allergic reactions to certain types of antibodies in the past.
Research Study Groups:
This trial has the following groups:- Group 1: BL-B01D1 administered Day 1 and Day 8 per cycle
- Group 2: BL-B01D1 administered Day 1 per cycle
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.
Are there any vacant slots for participants in the study?
"According to records on clinicaltrials.gov, this medical investigation is actively recruiting test subjects. The protocol was published in the beginning of August 8th 2023 and has recently been edited as of 11th of that same month."
Answered by AI
What is the risk of taking BL-B01D1 on both Day 1 and Day 8 in a single cycle for patients?
"Since this is a Phase 1 trial, with limited support for safety and efficacy, we at Power rated BL-B01D1 administered Day 1 and Day 8 per cycle as a score of one."
Answered by AI
How many participants will this experiment be taking on?
"Affirmative, clinicaltrials.gov indicates that the trial is open for recruitment. Originally posted on August 8th 2023 and recently updated on the 11th of same month, this experiment requires 100 patients from two sites to be enrolled in order to move forward."
Answered by AI
What is the main purpose of this investigation?
"As per the trial's sponsor, SystImmune Inc., the primary outcome will be monitored over a 1 year period and is focused on Serious Adverse Events (SAEs) or treatment-emergent adverse events (TEAEs). Furthermore, this research project measures secondary outcomes including Tmax of free payload ED-04, AUC(0-8) of BL-B01D1 ,and AUC(0–8) of anti-EGFR×HER3 antibodies."
Answered by AI
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