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

Primary Purpose

Non Small Cell Lung Cancer, NSCLC, Lung Cancer

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BL-B01D1
Sponsored by
SystImmune Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Sign informed consent Age: ≥18 years Expected survival > or = 3months 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. Agree to provide a tumor sample Has at least one measurable lesion based on RECIST 1.1 Has an Eastern Cooperative Oncology Group performance status (ECOG PS) 0 to 1 Exclusion Criteria: 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 Mixed small-cell lung cancer (SCLC) and NSCLC histology Subjects with history of severe heart disease Active autoimmune diseases and inflammatory diseases Other malignant tumors were diagnosed within 5 years Subjects with poorly controlled hypertension Subjects have Grade 3 lung disease or a history of interstitial lung disease Unstable thrombotic events such as deep vein thrombosis, arterial thrombosis, and pulmonary embolism requiring therapeutic intervention within the previous 6 months before screening Symptoms of active central nervous system metastasis. Subjects who have a history of allergies to recombinant humanized antibodies or human mouse chimeric antibodies or any of the components of BL-B01D1 Subjects have a history of autologous or allogeneic stem cell transplantation Known HIV, active tuberculosis, active Hepatitis B virus infection or active Hepatitis C virus infection Subjects with active infections requiring systemic treatment Participated in another clinical trial within 4 weeks prior to participating in the study Other conditions that the investigator believes that it is not suitable for participating in this clinical trial

Sites / Locations

  • Hematology/Oncology Associates of Treasure CoastRecruiting
  • Prisma Health Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

BL-B01D1 administered Day 1 and Day 8 per cycle

BL-B01D1 administered Day 1 per cycle

Arm Description

BL-B01D1 will be administered on Day 1 and Day 8 by intravenous infusion every 3 weeks

BL-B01D1 will be administered on Day 1 via by intravenous infusion every 3 weeks

Outcomes

Primary Outcome Measures

Participants with Dose-limiting toxicities
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),
Measuring the number of patients with serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs)
Participants with abnormal physical examination findings
Measure the number of participants with abnormal physical examination findings.
Participants with ability to care for themselves, daily activity, and physical activity
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
Measure the number of participants with abnormal ECG parameters
Participants with abnormal lab results
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
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

Cmax of BL-B01D1
Calculate maximum (peak) observed concentration of BL-B01D1
Cmax of anti-EGFR×HER3 antibody
Calculate maximum (peak) observed concentration of anti-EGFR×HER3 antibody
Cmax of free payload ED-04
Calculate maximum (peak) observed concentration of free payload ED-04
Tmax of BL-B01D1
Calculate time of maximum observed concentration of BL-B01D1
Tmax of anti-EGFR×HER3 antibody
Calculate time of maximum observed concentration of anti-EGFR×HER3 antibody
Tmax of free payload ED-04
Calculate time of maximum observed concentration of free payload ED-04
AUC(0-8) of BL-B01D1
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
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
Calculate area under the serum concentration-time curve of free payload ED-04 from time 0 to 8 hours
AUC(last) of BL-B01D1
Calculate area under the serum concentration-time curve up of BL-B01D1 to the last quantifiable time
AUC(last) anti-EGFR×HER3 antibodies
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
Calculate area under the serum concentration-time curve up of free payload ED-04 to the last quantifiable time
Overall Response Rate (ORR)
To assess the clinical efficacy of BL-B01D1 as measured by ORR using RECIST criteria v 1.1
Disease Control Rate (DCR)
To assess the clinical efficacy of BL-B01D1 as measured by DCR using RECIST criteria v 1.1
Time To Response (TTR)
To assess the clinical efficacy of BL-B01D1 as measured by TTR using RECIST criteria v 1.1
Progression-Free Survival (PFS),
To assess the clinical efficacy of BL-B01D1 as measured by PFS using RECIST criteria v 1.1
Overall Survival (OS).
To assess the clinical efficacy of BL-B01D1 as measured by OS using RECIST criteria v 1.1

Full Information

First Posted
July 12, 2023
Last Updated
September 19, 2023
Sponsor
SystImmune Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05983432
Brief Title
Study to Evaluate BL-B01D1 in Patients With Metastatic or Unresectable Non-Small Cell Lung Cancer (NSCLC)
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 8, 2023 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
September 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SystImmune Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer, NSCLC, Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BL-B01D1 administered Day 1 and Day 8 per cycle
Arm Type
Experimental
Arm Description
BL-B01D1 will be administered on Day 1 and Day 8 by intravenous infusion every 3 weeks
Arm Title
BL-B01D1 administered Day 1 per cycle
Arm Type
Experimental
Arm Description
BL-B01D1 will be administered on Day 1 via by intravenous infusion every 3 weeks
Intervention Type
Drug
Intervention Name(s)
BL-B01D1
Intervention Description
The study includes 3 parts: Part 1 Dose escalation. Part 2 Dose Finding non-randomized and Part 3 Dose expansion randomized.
Primary Outcome Measure Information:
Title
Participants with Dose-limiting toxicities
Description
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,
Time Frame
One year
Title
Participants with Serious Adverse Events (SAEs) and treatment-emergent adverse events (TEAEs),
Description
Measuring the number of patients with serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs)
Time Frame
One year
Title
Participants with abnormal physical examination findings
Description
Measure the number of participants with abnormal physical examination findings.
Time Frame
One year
Title
Participants with ability to care for themselves, daily activity, and physical activity
Description
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)
Time Frame
One year
Title
Participants with abnormal ECG reading
Description
Measure the number of participants with abnormal ECG parameters
Time Frame
One year
Title
Participants with abnormal lab results
Description
Measure the number of participants with abnormal clinical laboratory values
Time Frame
One year
Title
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
Description
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.
Time Frame
One year
Secondary Outcome Measure Information:
Title
Cmax of BL-B01D1
Description
Calculate maximum (peak) observed concentration of BL-B01D1
Time Frame
One year
Title
Cmax of anti-EGFR×HER3 antibody
Description
Calculate maximum (peak) observed concentration of anti-EGFR×HER3 antibody
Time Frame
One year
Title
Cmax of free payload ED-04
Description
Calculate maximum (peak) observed concentration of free payload ED-04
Time Frame
One year
Title
Tmax of BL-B01D1
Description
Calculate time of maximum observed concentration of BL-B01D1
Time Frame
One year
Title
Tmax of anti-EGFR×HER3 antibody
Description
Calculate time of maximum observed concentration of anti-EGFR×HER3 antibody
Time Frame
One year
Title
Tmax of free payload ED-04
Description
Calculate time of maximum observed concentration of free payload ED-04
Time Frame
One year
Title
AUC(0-8) of BL-B01D1
Description
Calculate area under the serum concentration-time curve of BL-B01D1 from time 0 to 8 hours
Time Frame
One year
Title
AUC(0-8) of anti-EGFR×HER3 antibodies
Description
Calculate area under the serum concentration-time curve of anti-EGFR×HER3 antibodies from time 0 to 8 hours
Time Frame
One year
Title
AUC(0-8) of free payload ED-04
Description
Calculate area under the serum concentration-time curve of free payload ED-04 from time 0 to 8 hours
Time Frame
One year
Title
AUC(last) of BL-B01D1
Description
Calculate area under the serum concentration-time curve up of BL-B01D1 to the last quantifiable time
Time Frame
One year
Title
AUC(last) anti-EGFR×HER3 antibodies
Description
Calculate area under the serum concentration-time curve up of anti-EGFR×HER3 antibodies to the last quantifiable time
Time Frame
One year
Title
AUC(last) of free payload ED-04
Description
Calculate area under the serum concentration-time curve up of free payload ED-04 to the last quantifiable time
Time Frame
One year
Title
Overall Response Rate (ORR)
Description
To assess the clinical efficacy of BL-B01D1 as measured by ORR using RECIST criteria v 1.1
Time Frame
One year
Title
Disease Control Rate (DCR)
Description
To assess the clinical efficacy of BL-B01D1 as measured by DCR using RECIST criteria v 1.1
Time Frame
One year
Title
Time To Response (TTR)
Description
To assess the clinical efficacy of BL-B01D1 as measured by TTR using RECIST criteria v 1.1
Time Frame
One year
Title
Progression-Free Survival (PFS),
Description
To assess the clinical efficacy of BL-B01D1 as measured by PFS using RECIST criteria v 1.1
Time Frame
One year
Title
Overall Survival (OS).
Description
To assess the clinical efficacy of BL-B01D1 as measured by OS using RECIST criteria v 1.1
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Sign informed consent Age: ≥18 years Expected survival > or = 3months 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. Agree to provide a tumor sample Has at least one measurable lesion based on RECIST 1.1 Has an Eastern Cooperative Oncology Group performance status (ECOG PS) 0 to 1 Exclusion Criteria: 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 Mixed small-cell lung cancer (SCLC) and NSCLC histology Subjects with history of severe heart disease Active autoimmune diseases and inflammatory diseases Other malignant tumors were diagnosed within 5 years Subjects with poorly controlled hypertension Subjects have Grade 3 lung disease or a history of interstitial lung disease Unstable thrombotic events such as deep vein thrombosis, arterial thrombosis, and pulmonary embolism requiring therapeutic intervention within the previous 6 months before screening Symptoms of active central nervous system metastasis. Subjects who have a history of allergies to recombinant humanized antibodies or human mouse chimeric antibodies or any of the components of BL-B01D1 Subjects have a history of autologous or allogeneic stem cell transplantation Known HIV, active tuberculosis, active Hepatitis B virus infection or active Hepatitis C virus infection Subjects with active infections requiring systemic treatment Participated in another clinical trial within 4 weeks prior to participating in the study Other conditions that the investigator believes that it is not suitable for participating in this clinical trial
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth D Lotz, MBA
Phone
(425) 453-6841
Email
elizabeth.lotz@systimmune.com
First Name & Middle Initial & Last Name or Official Title & Degree
Tara Barrineau
Phone
(425) 453-6841
Email
tara.barrineau@systimmune.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Leader
Organizational Affiliation
SystImmune Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Hematology/Oncology Associates of Treasure Coast
City
Port Saint Lucie
State/Province
Florida
ZIP/Postal Code
34952
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicholas Iannotti, MD
Phone
772-408-5159
Email
niannotti@hemoncfl.com
First Name & Middle Initial & Last Name & Degree
Christine Gerdes
Email
cgerdes@hemoncfl.com
Facility Name
Prisma Health Cancer Institute
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fiona Davidson, RN
Phone
864-455-3600
Email
Fiona.Davidson@prismahealth.org
First Name & Middle Initial & Last Name & Degree
Lisa Johnson, RN
Phone
864-455-3600
Email
Lisa.Johnson@prismahealth.org

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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