This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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.

Tracking Information
First Submitted Date  ICMJE July 12, 2023
First Posted Date  ICMJE August 9, 2023
Last Update Posted Date December 6, 2023
Actual Study Start Date  ICMJE August 8, 2023
Estimated Primary Completion Date July 31, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 1, 2023)
  • 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,
  • 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)
  • Participants with abnormal physical examination findings [ Time Frame: One year ]
    Measure the number of participants with abnormal physical examination findings.
  • 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)
  • Participants with abnormal ECG reading [ Time Frame: One year ]
    Measure the number of participants with abnormal ECG parameters
  • Participants with abnormal lab results [ Time Frame: One year ]
    Measure the number of participants with abnormal clinical laboratory values
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 1, 2023)
  • Cmax of BL-B01D1 [ Time Frame: One year ]
    Calculate maximum (peak) observed concentration of BL-B01D1
  • Cmax of anti-EGFR×HER3 antibody [ Time Frame: One year ]
    Calculate maximum (peak) observed concentration of anti-EGFR×HER3 antibody
  • Cmax of free payload ED-04 [ Time Frame: One year ]
    Calculate maximum (peak) observed concentration of free payload ED-04
  • Tmax of BL-B01D1 [ Time Frame: One year ]
    Calculate time of maximum observed concentration of BL-B01D1
  • Tmax of anti-EGFR×HER3 antibody [ Time Frame: One year ]
    Calculate time of maximum observed concentration of anti-EGFR×HER3 antibody
  • Tmax of free payload ED-04 [ Time Frame: One year ]
    Calculate time of maximum observed concentration of free payload ED-04
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate BL-B01D1 in Patients With Metastatic or Unresectable Non-Small Cell Lung Cancer (NSCLC)
Official Title  ICMJE A Phase 1 Study Evaluating the Safety, Tolerability, and Efficacy of BL-B01D1 in Subjects With Metastatic or Unresectable Non-Small Cell Lung Cancer
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).
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Non Small Cell Lung Cancer
  • NSCLC
  • Lung Cancer
Intervention  ICMJE Drug: BL-B01D1
The study includes 3 parts: Part 1 Dose escalation. Part 2 Dose Finding non-randomized and Part 3 Dose expansion randomized.
Study Arms  ICMJE
  • 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
    Intervention: Drug: BL-B01D1
  • Experimental: BL-B01D1 administered Day 1 per cycle
    BL-B01D1 will be administered on Day 1 via by intravenous infusion every 3 weeks
    Intervention: Drug: BL-B01D1
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 1, 2023)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2025
Estimated Primary Completion Date July 31, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Elizabeth D Lotz, MBA (425) 453-6841 elizabeth.lotz@systimmune.com
Contact: Tara Barrineau (425) 453-6841 tara.barrineau@systimmune.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05983432
Other Study ID Numbers  ICMJE BL-B01D1-LUNG-101
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party SystImmune Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE SystImmune Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Leader SystImmune Inc.
PRS Account SystImmune Inc.
Verification Date December 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP