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

• ClinicalTrials.gov Identifier: NCT05983432
• Recruitment Status: Recruiting
• First Posted: August 9, 2023
• Last Update Posted: May 3, 2024
• Sponsor: SystImmune Inc.
• Information provided by (Responsible Party): SystImmune Inc.

Tracking Information

• First Submitted Date: July 12, 2023
• First Posted Date: August 9, 2023
• Last Update Posted Date: May 3, 2024
• Actual Study Start Date: August 8, 2023
• Estimated Primary Completion Date: July 31, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study to Evaluate BL-B01D1 in Patients With Metastatic or Unresectable Non-Small Cell Lung Cancer (NSCLC) and Other Solid Tumors
• 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 and Other Solid Tumors
• 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) and Other Solid Tumors.

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 and Other Solid Tumors.

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
• Study Phase: Phase 1
• Study Design: Allocation: Non-Randomized; Intervention Model: Sequential Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Non Small Cell Lung Cancer
• NSCLC
• Lung Cancer
• Breast Cancer
• Esophageal Cancer
• SCLC
• Small Cell Lung Cancer
• NPC
• Nasopharyngeal Cancer

Intervention

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

• 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

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: May 2, 2024): 260
• Original Estimated Enrollment (submitted: August 1, 2023): 100
• Estimated Study Completion Date: September 30, 2025
• Estimated Primary Completion Date: July 31, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Sign informed consent
2. Expected survival > or = 3months
3. Has histologically documented, incurable, locally advanced or metastatic epithelial origin malignant cancer, priority to include the following tumor types: Non-Small Cell Lung Cancer, HER2- breast cancer, esophageal cancer, Small Cell Lung Cancer, and Nasopharyngeal Cancer.
4. Agree to provide a tumor sample
5. Has at least one measurable lesion based on RECIST 1.1
6. 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. Subjects with history of severe heart disease
3. Active autoimmune diseases and inflammatory diseases
4. Other malignant tumors were diagnosed within 5 years
5. Subjects with poorly controlled hypertension
6. Subjects have Grade 3 lung disease or a history of interstitial lung disease
7. Unstable thrombotic events such as deep vein thrombosis, arterial thrombosis, and pulmonary embolism requiring therapeutic intervention within the previous 6 months before screening
8. Symptoms of active central nervous system metastasis.
9. Subjects who have a history of allergies to recombinant humanized antibodies or human mouse chimeric antibodies or any of the components of BL-B01D1
10. Subjects have a history of autologous or allogeneic stem cell transplantation
11. Known HIV, active tuberculosis, active Hepatitis B virus infection or active Hepatitis C virus infection
12. Subjects with active infections requiring systemic treatment
13. Participated in another clinical trial within 4 weeks prior to participating in the study
14. Other conditions that the investigator believes that it is not suitable for participating in this clinical trial

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Ta Barrineau; (425) 453-6841; tara.barrineau@systimmune.com

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05983432
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Current Responsible Party: SystImmune Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: SystImmune Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Clinical Leader; SystImmune Inc.

• PRS Account: SystImmune Inc.
• Verification Date: May 2024