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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05983432
• Other study ID #: BL-B01D1-LUNG-101
• Status: Recruiting
• Phase: Phase 1
• Start date: August 8, 2023
• Est. completion date: September 30, 2025

Study information

• Verified date: May 2024
• Source: SystImmune Inc.
• Contact: Ta Barrineau
• Phone: (425) 453-6841
• Email: tara.barrineau[@]systimmune.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 260
• Est. completion date: September 30, 2025
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Carcinoma, Non-Small-Cell Lung
• Esophageal Cancer
• Lung Cancer
• Lung Neoplasms
• Nasopharyngeal Cancer
• Nasopharyngeal Carcinoma
• Nasopharyngeal Neoplasms
• Non Small Cell Lung Cancer
• NPC
• NSCLC
• SCLC
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

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.

Locations

Country	Name	City	State
United States	SystImmune Recruiting Site	Boulder	Colorado
United States	SystImmune Recruiting Center	Dallas	Texas
United States	SystImmune Recruiting Site	Fairfax	Virginia
United States	SystImmune Recruiting Center	Greenville	South Carolina
United States	SystImmune Recruiting Site	Hackensack	New Jersey
United States	SystImmune Recruiting Site	Houston	Texas
United States	SystImmune Recruiting Center	Nashville	Tennessee
United States	SystImmune Recruiting Center	New York	New York
United States	SystImmune Recruiting Site	Orange	California
United States	SystImmune Recruiting Center	Port Saint Lucie	Florida

Sponsors (1)

Lead Sponsor	Collaborator
SystImmune Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Participants with abnormal physical examination findings	Measure the number of participants with abnormal physical examination findings.	One year
Primary	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
Primary	Participants with abnormal ECG reading	Measure the number of participants with abnormal ECG parameters	One year
Primary	Participants with abnormal lab results	Measure the number of participants with abnormal clinical laboratory values	One year
Primary	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	Cmax of BL-B01D1	Calculate maximum (peak) observed concentration of BL-B01D1	One year
Secondary	Cmax of anti-EGFR×HER3 antibody	Calculate maximum (peak) observed concentration of anti-EGFR×HER3 antibody	One year
Secondary	Cmax of free payload ED-04	Calculate maximum (peak) observed concentration of free payload ED-04	One year
Secondary	Tmax of BL-B01D1	Calculate time of maximum observed concentration of BL-B01D1	One year
Secondary	Tmax of anti-EGFR×HER3 antibody	Calculate time of maximum observed concentration of anti-EGFR×HER3 antibody	One year
Secondary	Tmax of free payload ED-04	Calculate time of maximum observed concentration of free payload ED-04	One year
Secondary	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
Secondary	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
Secondary	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
Secondary	AUC(last) of BL-B01D1	Calculate area under the serum concentration-time curve up of BL-B01D1 to the last quantifiable time	One year
Secondary	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
Secondary	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
Secondary	Overall Response Rate (ORR)	To assess the clinical efficacy of BL-B01D1 as measured by ORR using RECIST criteria v 1.1	One year
Secondary	Disease Control Rate (DCR)	To assess the clinical efficacy of BL-B01D1 as measured by DCR using RECIST criteria v 1.1	One year
Secondary	Time To Response (TTR)	To assess the clinical efficacy of BL-B01D1 as measured by TTR using RECIST criteria v 1.1	One year
Secondary	Progression-Free Survival (PFS),	To assess the clinical efficacy of BL-B01D1 as measured by PFS using RECIST criteria v 1.1	One year
Secondary	Overall Survival (OS).	To assess the clinical efficacy of BL-B01D1 as measured by OS using RECIST criteria v 1.1	One year