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

NCT05983432 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: BL-B01D1-LUNG-101
• Study Type: interventional
• Target: 470
• Locations: 5 countries
• Sites: 39

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.

Conditions

Non Small Cell Lung Cancer; Lung Cancer; Breast Cancer; Esophageal Cancer; Small Cell Lung Cancer; Nasopharyngeal Cancer; Head and Neck Squamous Cell Carcinoma; Prostate Adenocarcinoma; Ovarian Cancer; Endometrial Cancer; Cervical Cancer; Triple Negative Breast Cancer

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (18)

• Cmax of BL-B01D1

  One year

• Cmax of anti-EGFR×HER3 antibody

  One year

• Cmax of free payload ED-04

  One year

• Tmax of BL-B01D1

  One year

• Tmax of anti-EGFR×HER3 antibody

  One year

Study Arms (2)

BL-B01D1 administered Day 1 and Day 8 per cycle

EXPERIMENTAL

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

Drug: BL-B01D1

BL-B01D1 administered Day 1 per cycle

EXPERIMENTAL

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

Drug: BL-B01D1

Interventions

BL-B01D1 DRUG

BL-B01D1 will be administered either on a Day 1 or Day 1 Day 8 dosing regimen

BL-B01D1 administered Day 1 and Day 8 per cycle; BL-B01D1 administered Day 1 per cycle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed the informed consent voluntarily and agreed to follow the program requirements
• Either sex
• Age: ≥18 years
• Has a life expectancy of ≥3 months
• Has histologically documented, incurable, locally advanced or metastatic epithelial origin malignant cancer, priority to include the following tumor types: NSCLC, HER2 - breast cancer, esophageal cancer, SCLC, NPC, and HNSCC.
• Has documented locally advanced or metastatic HER2 negative (by immunohistochemistry \[IHC\], score of 0 or 1) Hormone Receptor (HR) positive (HER2-, HR+) OR HER2 negative (IHC score of 0 to 2) HR negative breast cancer (HER2-, HR-) as per ASCO CAP criteria (ASCO CAP 2023; Wolff et al. 2023), 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, must have received 1 prior line of chemotherapy for advanced disease and, when applicable and if approved in that region, a PD-1/PD-L1 inhibitor, either given concurrently or sequentially. When appropriate, must have progression on at least 1 prior line of hormonal therapy with or without a targeted therapy (such as CDK4/6, mTOR, or PI3-K inhibitors) administered for treatment of metastatic disease.
• In Dose Escalation and Dose finding portions of the study, for triple-negative breast cancer (TNBC, HER2-/HR-) participants must have received PARP inhibitors if a BRCA mutation is present and sacituzumab govitecan as second line treatment. Participants who are HER2 low must have received trastuzumab deruxtecan.
• Agree to provide archived tumor samples (tissue block or slides) from primary or metastatic sites within 2 years. In the event that no archival tissue is available a fresh tissue biopsy is highly encouraged but not mandatory.
• Has at least one measurable lesion based on RECIST V1.1 (with the exception of Prostate adenocarcinoma cohort, where subjects with bone metastasis are allowed)
• Has an Eastern Cooperative Oncology Group performance status (ECOG PS) 0 to 1
• Toxicity of previous antitumor therapy has returned to level ≤1 as defined by NCI-CTCAE V5.0 (except for asymptomatic laboratory abnormalities such as elevated ALP, hyperuricemia, elevated serum or plasma amylase/lipase, and elevated blood glucose; except for toxicity that the investigator determined to have no safety risk, such as alopecia, grade 2 peripheral neurotoxicity, hypothyroidism stabilized by hormone replacement therapy, etc.)
• Has no serious cardiac dysfunction, left ventricular ejection fraction ≥50%
• Has adequate organ function before registration, defined as: a) Marrow Function: Absolute neutrophil count (ANC) ≥1.2×109 /L, Platelet count ≥100×109 /L, Hemoglobin (Hb) ≥90 g/L b) Hepatic function: Total bilirubin（TBIL≤1.5 ULN, AST and ALT without liver metastasis ≤2.5 ULN, AST and ALT with liver metastasis ≤5.0 ULN c) Renal function: Creatinine clearance ≥50 mL/min (According to the Cockcroft and Gault equation)
• Coagulation function: international normalized ratio (INR) ≤1.5×ULN, and activated partial thromboplastin time (APTT) ≤1.5 ULN
• Urinary protein ≤2+ or ≤1000mg/24 hours

You may not qualify if:

• Chemotherapy, biological therapy, immunotherapy, radical radiotherapy, targeted therapy (including small molecule inhibitor of tyrosine kinase), and other anti-tumor therapy within 2 weeks or 5 half-lives (whichever is shorter) prior to the first administration; major surgery within 4 weeks prior to the first administration; mitomycin and nitrosoureas treatment within 6 weeks prior to the first administration
• Participants with history of severe heart disease, such as symptomatic congestive heart failure (CHF) ≥ Grade 2 (CTCAE 5.0), New York Heart Association (NYHA) ≥ Grade 2 heart failure, history of transmural myocardial infarction, unstable angina pectoris etc;
• Subjects with prolonged QT interval (QTc \>470 msec), complete left bundle branch block, Grade 3 atrioventricular block
• Active autoimmune diseases and inflammatory diseases, such as: systemic lupus erythematosus, psoriasis requiring systemic treatment, rheumatoid arthritis, inflammatory bowel disease and Hashimoto's thyroiditis, etc., except for Type I diabetes, hypothyroidism that can be controlled only by standard of care treatment, and skin diseases that do not require systemic treatment (such as vitiligo, psoriasis)
• Other malignant tumors were diagnosed within 5 years prior to the first administration with the following exceptions: basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or carcinoma in situ after radical resection
• Participants with poorly controlled hypertension by two kinds of antihypertensive drugs (systolic blood pressure\>150 mmHg or diastolic blood pressure\>100 mmHg)
• Participants have Grade 3 lung disease defined according to NCI-CTCAE v5.0, a history of interstitial lung disease (ILD)/ pneumonitis
• Unstable thrombotic events such as deep vein thrombosis, arterial thrombosis, and pulmonary embolism requiring therapeutic intervention within the previous 6 months before screening; Infusion set-related thrombosis is excluded
• Participants with primary tumors in the central nervous system (CNS) and active or untreated CNS metastases and/or carcinomatous meningitis should be excluded. Participants with previously treated brain metastases may participate provided they are clinically stable for at least 4 weeks and have no evidence of new or enlarging brain metastases and no requirements for corticosteroids 14 days prior to dosing with the investigational product (IP). Participants on low dose corticosteroids (\<20 mg prednisone or equivalent/day) may participate.
• Participants who have a history of allergies to recombinant humanized antibodies or human-mouse chimeric antibodies or any of the components of BL-B01D1
• Participants have a history of autologous or allogeneic stem cell transplantation (Allo-HSCT)
• Has received treatment with anthracyclines with a cumulative dose exceeding 360 mg/m2
• Participants with ≥ Grade 2 hypokalemia (low concentration of potassium in the blood) according to CTCAE v5.0 (Grade 1: participant asymptomatic with potassium levels \<LLN - 3.0 mmol/L or equivalent)
• Known Human immunodeficiency virus antibody (HIVAb) positive, active tuberculosis, active Hepatitis B virus infection (HBV-DNA copy number\> the lower limit of detection) or active Hepatitis C virus infection (HCV antibody positive and HCV-RNA \> the lower limit of detection)
• Participants with active infections requiring systemic treatment, such as severe pneumonia, bacteremia, sepsis.

Sponsors & Collaborators

• SystImmune Inc.: lead

Study Sites (39)

Beverly Hills Cancer Center

Beverly Hills, California, 90211, United States

RECRUITING

City of Hope Cancer Center

Duarte, California, 91010, United States

RECRUITING

Chao Family Comprehensive Cancer Care and Ambulatory Care

Irvine, California, 92612, United States

NOT YET RECRUITING

Chao Family Comprehensive Cancer Center and Ambulatory Care

Irvine, California, 92612, United States

NOT YET RECRUITING

University of California Irvine Medical Center

Orange, California, 92868, United States

RECRUITING

UCLA Santa Monica

Santa Monica, California, 90404, United States

RECRUITING

University of Colorado Cancer Center

Aurora, Colorado, 80045, United States

RECRUITING

Yale University, Yale Cancer Center

New Haven, Connecticut, 06520, United States

RECRUITING

Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

RECRUITING

Sylvester Comprehensive Cancer Center

Miami, Florida, 33125, United States

RECRUITING

Sara Cannon Research Institute Lake Nona

Orlando, Florida, 32827, United States

RECRUITING

Hematology - Oncology Associates of the Treasure Coast

Port Saint Lucie, Florida, 34952, United States

RECRUITING

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

RECRUITING

University of Iowa Hospital and Clinics

Iowa City, Iowa, 52242, United States

RECRUITING

Norton Cancer Institute

Louisville, Kentucky, 40202, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

Memorial Sloan Kettering Cancer Center Head Neck Services

New York, New York, 10065, United States

RECRUITING

PRISMA Health/ITOR

Greenville, South Carolina, 29605, United States

RECRUITING

Sarah Cannon - Tennessee Oncology

Nashville, Tennessee, 37203, United States

RECRUITING

Oncology Consultants, P.A.

Houston, Texas, 77030, United States

RECRUITING

University of Texas M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Virginia Cancer Specialists

Fairfax, Virginia, 22031, United States

RECRUITING

University of Washington Fred Hutchinson

Seattle, Washington, 98109, United States

RECRUITING

Centre Léon Bérard

Lyon, 69373, France

RECRUITING

Groupe Hospitalier Pitie-Salpetriere

Paris, 75013, France

RECRUITING

Institut de Cancerologie de Ouest (ICO) - Saint-Herblain

Saint-Herblain, 44805, France

RECRUITING

Institut Gustave Roussy

Villejuif, 94800, France

RECRUITING

Fondazione del Piemonte per l'Oncologia IRCC Candiolo

Candiolo, 10060, Italy

RECRUITING

IRCCS Istituto Clinico Humanitas, Cancer Center

Rozzano, 20089, Italy

RECRUITING

National Cancer Center Hospital

Chūōku, 104-0045, Japan

RECRUITING

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

RECRUITING

Hospital de la Santa Creu I Sant Pau

Barcelona, 8041, Spain

RECRUITING

Hospital Beata María Ana

Madrid, 28007, Spain

RECRUITING

START Madrid / Hospital Universitario Fundacion Jimenez Diaz

Madrid, 28040, Spain

RECRUITING

Hospital Universitario 12 De Octubre

Madrid, 28041, Spain

RECRUITING

START Madrid / Centro Integral Oncologico Clara Campal

Madrid, 28050, Spain

RECRUITING

START Rioja

Piqueras, 26006, Spain

NOT YET RECRUITING

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms; Breast Neoplasms; Esophageal Neoplasms; Small Cell Lung Carcinoma; Nasopharyngeal Neoplasms; Squamous Cell Carcinoma of Head and Neck; Ovarian Neoplasms; Endometrial Neoplasms; Uterine Cervical Neoplasms; Triple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Uterine Neoplasms; Uterine Diseases; Uterine Cervical Diseases

Study Officials

• Jimmy Zhao, MD, PhD

  SystImmune Inc.

  STUDY DIRECTOR

Central Study Contacts

Tara Barrineau

CONTACT

425-453-6841; tara.barrineau@systimmune.com

Colandra McDowell

CONTACT

colandra.mcdowell@systimmune.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2023
• First Posted: August 9, 2023
• Study Start: August 8, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 21, 2028
• Last Updated: January 29, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (24); ES (8); IT (2); JP (1); FR (4)