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Study to Evaluate BL-B01D1 in Patients With Metastatic or Unresectable Non-Small Cell Lung Cancer (NSCLC)

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ClinicalTrials.gov Identifier: NCT05983432
Recruitment Status : Recruiting
First Posted : August 9, 2023
Last Update Posted : December 6, 2023
Sponsor:
Information provided by (Responsible Party):
SystImmune Inc.

Study Description
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Brief Summary:
The objective of this study is to evaluate the safety, tolerability, and efficacy of BL-B01D1 in patients with Metastatic or Unresectable Non-Small Cell Lung Cancer (NSCLC).

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer NSCLC Lung Cancer Drug: BL-B01D1 Phase 1

Detailed Description:

BL-B01D1-LUNG-101 is a global, multi-center, Phase 1 study to evaluate the safety, tolerability, pharmacokinetics , and initial efficacy of BL-B01D1 in participants with metastatic or unresectable NSCLC.

This study will be conducted in two different dosing schedules (Cohort A and Cohort B) and three parts (dose escalation, dose finding and dose expansion). Cohort A will be dosed on Day 1 and Day 8 of a continuous 21-day treatment cycle. Cohort B will be dosed on Day 1 of a continuous 21-day treatment cycle. Each Cohort has different dose groups.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study Evaluating the Safety, Tolerability, and Efficacy of BL-B01D1 in Subjects With Metastatic or Unresectable Non-Small Cell Lung Cancer
Actual Study Start Date : August 8, 2023
Estimated Primary Completion Date : July 31, 2024
Estimated Study Completion Date : September 30, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: BL-B01D1 administered Day 1 and Day 8 per cycle
BL-B01D1 will be administered on Day 1 and Day 8 by intravenous infusion every 3 weeks
 Drug: BL-B01D1
The study includes 3 parts: Part 1 Dose escalation. Part 2 Dose Finding non-randomized and Part 3 Dose expansion randomized.
Experimental: BL-B01D1 administered Day 1 per cycle
BL-B01D1 will be administered on Day 1 via by intravenous infusion every 3 weeks
 Drug: BL-B01D1
The study includes 3 parts: Part 1 Dose escalation. Part 2 Dose Finding non-randomized and Part 3 Dose expansion randomized.


Outcome Measures
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Primary Outcome Measures :
  1. Participants with Dose-limiting toxicities [ Time Frame: One year ]

    Measuring the number of patients Dose-limiting toxicities (DLTs). A DLT is defined as any of the following events that are not clearly due to the underlying disease or extraneous causes:

    Hematological toxicities:

    • Grade 4 neutrophil count decreased lasting >7 days
    • Grade ≥3 febrile neutropenia
    • Grade ≥3 platelet count decreased with clinically significant hemorrhage.

    Non-Hematological toxicities:

    • Death
    • Hy's law cases
    • Grade ≥3 non-hematological toxicities,

  2. Participants with Serious Adverse Events (SAEs) and treatment-emergent adverse events (TEAEs), [ Time Frame: One year ]
    Measuring the number of patients with serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs)

  3. Participants with abnormal physical examination findings [ Time Frame: One year ]
    Measure the number of participants with abnormal physical examination findings.

  4. Participants with ability to care for themselves, daily activity, and physical activity [ Time Frame: One year ]
    Measure the change in participants with Eastern Clinical Oncology Group (ECOG) Scale of Performance Status. The scale is 0-4 with 0 being the fully active (best outcome) and 4 being completely disabled (worst outcome)

  5. Participants with abnormal ECG reading [ Time Frame: One year ]
    Measure the number of participants with abnormal ECG parameters

  6. Participants with abnormal lab results [ Time Frame: One year ]
    Measure the number of participants with abnormal clinical laboratory values

  7. To determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and two or more recommended doses and schedules for recommended dose expansion (RDEs) of BL-B01D1 in metastatic NSCLC [ Time Frame: One year ]
    Determine the highest BL-B01D1 dose level at which ≤33% subjects experience a DLT during the DLT evaluation period and highest BL-B01D1 dose administered in the event and MTD cannot be defined.


Secondary Outcome Measures :
  1. Cmax of BL-B01D1 [ Time Frame: One year ]
    Calculate maximum (peak) observed concentration of BL-B01D1

  2. Cmax of anti-EGFR×HER3 antibody [ Time Frame: One year ]
    Calculate maximum (peak) observed concentration of anti-EGFR×HER3 antibody

  3. Cmax of free payload ED-04 [ Time Frame: One year ]
    Calculate maximum (peak) observed concentration of free payload ED-04

  4. Tmax of BL-B01D1 [ Time Frame: One year ]
    Calculate time of maximum observed concentration of BL-B01D1

  5. Tmax of anti-EGFR×HER3 antibody [ Time Frame: One year ]
    Calculate time of maximum observed concentration of anti-EGFR×HER3 antibody

  6. Tmax of free payload ED-04 [ Time Frame: One year ]
    Calculate time of maximum observed concentration of free payload ED-04

  7. AUC(0-8) of BL-B01D1 [ Time Frame: One year ]
    Calculate area under the serum concentration-time curve of BL-B01D1 from time 0 to 8 hours

  8. AUC(0-8) of anti-EGFR×HER3 antibodies [ Time Frame: One year ]
    Calculate area under the serum concentration-time curve of anti-EGFR×HER3 antibodies from time 0 to 8 hours

  9. AUC(0-8) of free payload ED-04 [ Time Frame: One year ]
    Calculate area under the serum concentration-time curve of free payload ED-04 from time 0 to 8 hours

  10. AUC(last) of BL-B01D1 [ Time Frame: One year ]
    Calculate area under the serum concentration-time curve up of BL-B01D1 to the last quantifiable time

  11. AUC(last) anti-EGFR×HER3 antibodies [ Time Frame: One year ]
    Calculate area under the serum concentration-time curve up of anti-EGFR×HER3 antibodies to the last quantifiable time

  12. AUC(last) of free payload ED-04 [ Time Frame: One year ]
    Calculate area under the serum concentration-time curve up of free payload ED-04 to the last quantifiable time

  13. Overall Response Rate (ORR) [ Time Frame: One year ]
    To assess the clinical efficacy of BL-B01D1 as measured by ORR using RECIST criteria v 1.1

  14. Disease Control Rate (DCR) [ Time Frame: One year ]
    To assess the clinical efficacy of BL-B01D1 as measured by DCR using RECIST criteria v 1.1

  15. Time To Response (TTR) [ Time Frame: One year ]
    To assess the clinical efficacy of BL-B01D1 as measured by TTR using RECIST criteria v 1.1

  16. Progression-Free Survival (PFS), [ Time Frame: One year ]
    To assess the clinical efficacy of BL-B01D1 as measured by PFS using RECIST criteria v 1.1

  17. Overall Survival (OS). [ Time Frame: One year ]
    To assess the clinical efficacy of BL-B01D1 as measured by OS using RECIST criteria v 1.1


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Sign informed consent
  2. Age: ≥18 years
  3. Expected survival > or = 3months
  4. 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.
  5. Agree to provide a tumor sample
  6. Has at least one measurable lesion based on RECIST 1.1
  7. Has an Eastern Cooperative Oncology Group performance status (ECOG PS) 0 to 1

Exclusion Criteria:

  1. Chemotherapy, biological therapy, immunotherapy, radical radiotherapy, major surgery, targeted therapy and other anti-tumor therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to the first administration
  2. Mixed small-cell lung cancer (SCLC) and NSCLC histology
  3. Subjects with history of severe heart disease
  4. Active autoimmune diseases and inflammatory diseases
  5. Other malignant tumors were diagnosed within 5 years
  6. Subjects with poorly controlled hypertension
  7. Subjects have Grade 3 lung disease or a history of interstitial lung disease
  8. Unstable thrombotic events such as deep vein thrombosis, arterial thrombosis, and pulmonary embolism requiring therapeutic intervention within the previous 6 months before screening
  9. Symptoms of active central nervous system metastasis.
  10. Subjects who have a history of allergies to recombinant humanized antibodies or human mouse chimeric antibodies or any of the components of BL-B01D1
  11. Subjects have a history of autologous or allogeneic stem cell transplantation
  12. Known HIV, active tuberculosis, active Hepatitis B virus infection or active Hepatitis C virus infection
  13. Subjects with active infections requiring systemic treatment
  14. Participated in another clinical trial within 4 weeks prior to participating in the study
  15. Other conditions that the investigator believes that it is not suitable for participating in this clinical trial
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05983432


Contacts
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Contact: Elizabeth D Lotz, MBA (425) 453-6841 elizabeth.lotz@systimmune.com
Contact: Tara Barrineau (425) 453-6841 tara.barrineau@systimmune.com

Locations
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United States, Florida
SystImmune Recruiting Center Recruiting
Port Saint Lucie, Florida, United States, 34952
United States, New York
SystImmune Recruiting Center Not yet recruiting
New York, New York, United States, 10065
United States, South Carolina
SystImmune Recruiting Center Recruiting
Greenville, South Carolina, United States, 29605
United States, Tennessee
SystImmune Recruiting Center Not yet recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
SystImmune Recruiting Center Recruiting
Dallas, Texas, United States, 75230
SystImmune Recruiting Site Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
SystImmune Inc.
Investigators
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Study Director: Clinical Leader SystImmune Inc.
More Information
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Responsible Party: SystImmune Inc.
ClinicalTrials.gov Identifier: NCT05983432    
Other Study ID Numbers: BL-B01D1-LUNG-101
First Posted: August 9, 2023    Key Record Dates
Last Update Posted: December 6, 2023
Last Verified: December 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms