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
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
SystImmune Inc. |
United States,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04681911 -
Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer
|
Phase 2 | |
Completed |
NCT04890327 -
Web-based Family History Tool
|
N/A | |
Terminated |
NCT04066790 -
Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer
|
Phase 2 | |
Completed |
NCT03591848 -
Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility
|
N/A | |
Recruiting |
NCT03954197 -
Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients
|
N/A | |
Terminated |
NCT02202746 -
A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer
|
Phase 2 | |
Active, not recruiting |
NCT01472094 -
The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
|
||
Completed |
NCT06049446 -
Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
|
||
Withdrawn |
NCT06057636 -
Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study
|
N/A | |
Recruiting |
NCT05560334 -
A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations
|
Phase 2 | |
Active, not recruiting |
NCT05501769 -
ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer
|
Phase 1 | |
Recruiting |
NCT04631835 -
Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer
|
Phase 1 | |
Completed |
NCT04307407 -
Exercise in Breast Cancer Survivors
|
N/A | |
Recruiting |
NCT03544762 -
Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation
|
Phase 3 | |
Terminated |
NCT02482389 -
Study of Preoperative Boost Radiotherapy
|
N/A | |
Enrolling by invitation |
NCT00068003 -
Harvesting Cells for Experimental Cancer Treatments
|
||
Completed |
NCT00226967 -
Stress, Diurnal Cortisol, and Breast Cancer Survival
|
||
Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
Recruiting |
NCT06019325 -
Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy
|
N/A |