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Monoclonal Antibodies

BL-B01D1 for Lung Cancer

Phase 1
Recruiting
Research Sponsored by SystImmune Inc.
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
Must not have
Active autoimmune diseases and inflammatory diseases
Subjects have Grade 3 lung disease or a history of interstitial lung disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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I am 18 years old or older.
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My advanced lung cancer cannot be cured with surgery or radiation, and it has worsened despite treatment.
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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have an active autoimmune or inflammatory disease.
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I have severe lung disease or a history of tissue scarring in my lungs.
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I haven't had serious blood clot issues needing treatment in the last 6 months.
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I was diagnosed with another cancer within the last 5 years.
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I am currently being treated for an active infection.
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I have a history of severe heart disease.
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I do not have active HIV, tuberculosis, Hepatitis B, or Hepatitis C.
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I have had a stem cell transplant using my own or donor cells.
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My high blood pressure is not well-managed.
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I have symptoms from cancer spread to my brain.
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My lung cancer is a mix of small-cell and non-small cell types.
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I haven't had cancer treatments like chemotherapy or surgery in the last 4 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
This trial's timeline: 3 weeks for screening, Varies for treatment, and one year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 more
Secondary study objectives
AUC(0-8) of BL-B01D1
AUC(0-8) of anti-EGFR×HER3 antibodies
AUC(0-8) of free payload ED-04
+14 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial 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

BL-B01D1 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05983432 — Phase 1
Esophageal Cancer Research Study Groups: BL-B01D1 administered Day 1 and Day 8 per cycle, BL-B01D1 administered Day 1 per cycle
Esophageal Cancer Clinical Trial 2023: BL-B01D1 Highlights & Side Effects. Trial Name: NCT05983432 — Phase 1
BL-B01D1 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05983432 — Phase 1
~121 spots leftby Dec 2025
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