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

A Phase 1 Study Evaluating the Safety, Tolerability, and Efficacy of BL-B01D1 in Subjects With Metastatic or Unresectable Non-Small Cell Lung Cancer

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).

Study Overview

• Status: Recruiting
• Conditions: NSCLC; Lung Cancer; Non Small Cell Lung Cancer
• Intervention / Treatment: Drug: BL-B01D1

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: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Elizabeth D Lotz, MBA; Phone Number: (425) 453-6841; Email: elizabeth.lotz@systimmune.com
• Study Contact Backup: Name: Tara Barrineau; Phone Number: (425) 453-6841; Email: tara.barrineau@systimmune.com

Study Locations

• United States
  • Florida
    • Port Saint Lucie, Florida, United States, 34952
      • Recruiting
      • SystImmune Recruiting Center
  • New York
    • New York, New York, United States, 10065
      • Not yet recruiting
      • SystImmune Recruiting Center
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Recruiting
      • SystImmune Recruiting Center
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Not yet recruiting
      • SystImmune Recruiting Center
  • Texas
    • Dallas, Texas, United States, 75230
      • Recruiting
      • SystImmune Recruiting Center
    • Houston, Texas, United States, 77030
      • Recruiting
      • SystImmune Recruiting Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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,	One year
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)	One year
Participants with abnormal physical examination findings	Measure the number of participants with abnormal physical examination findings.	One year
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)	One year
Participants with abnormal ECG reading	Measure the number of participants with abnormal ECG parameters	One year
Participants with abnormal lab results	Measure the number of participants with abnormal clinical laboratory values	One year
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.	One year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: SystImmune Inc.
• Investigators: Study Director: Clinical Leader, SystImmune Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2023
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: July 12, 2023
• First Submitted That Met QC Criteria: August 1, 2023
• First Posted (Actual): August 9, 2023

Study Record Updates

• Last Update Posted (Estimated): December 6, 2023
• Last Update Submitted That Met QC Criteria: December 4, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: BL-B01D1-LUNG-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No