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New treatment option for Non Small Cell Lung Cancer
Official title Evaluate BL-B01D1 in Patients With Metastatic or Unresectable Non-Small Cell Lung Cancer (NSCLC) and Other Solid Tumors
ClinicalTrials.gov ID: NCT05983432
What this study is testing
What is BL-B01D1?
BL-B01D1 is an investigational medicine, being studied as a potential treatment for non small cell lung cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
You likely can't join if
- Chemotherapy, biological therapy, immunotherapy, radical radiotherapy, targeted therapy (including small molecule inhibitor of tyrosine kinase), and...
- Participants with history of severe heart disease, such as symptomatic congestive heart failure (CHF) ≥ Grade 2 (CTCAE 5.0), New York Heart...
- people 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...
- Other malignant tumors were diagnosed within 5 years prior to the first administration with the following exceptions: basal cell carcinoma of the...
- Participants with poorly controlled hypertension by two kinds of antihypertensive drugs (systolic blood pressure\>150 mmHg or diastolic blood...
See the full eligibility criteria
Who can join
- 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...
- 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...
- Has at least one measurable lesion based on RECIST V1.1 (with the exception of Prostate adenocarcinoma cohort, where people 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...
- 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...
- 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
- Sexually active fertile people and their partners must agree to use highly effective methods of contraception during the course of the study and for 7 months for females and 4 months for males after the last dose of...
- Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at screening and must be nonlactating. Female people are considered WOCBP unless one of the following criteria are met: documented...
- For people with NSCLC (EGFR mutation): a) Evidence of documented EGFR TKI-sensitizing deletion mutation in EGFR Exon 19 (ex19del) or leucin-arginine substitution point mutation in EGFR Exon 21 (ex21L858R), the...
- For Triple-Negative Breast Cancer (TNBC, HER2-/HR-): a) Histologically or cytologically confirmed and documented locally advanced, recurrent inoperable or metastatic TNBC
- For Esophageal adenocarcinoma a) Has locally advanced or metastatic adenocarcinoma cell carcinoma of the esophagus or esophagogastric junction cancers, not amenable to curative surgery or radiation with documentation of...
- For Prostate adenocarcinoma a) Subject has metastatic castration-resistant prostate cancer (mCRPC) after progression on/after an androgen receptor pathway inhibitors (ARPI) treatment, such as abiraterone, enzalutamide...
- For NSCLC (EGFR wild type) with squamous histology
- 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...
- Must have documented negative test results for epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK). Must have no known genomic alterations in ROS proto-oncogene 1 (ROS1).
- Progressed or intolerant to one line of platinum-based chemotherapy with α-PD-1/L1 monoclonal antibody given either concurrently or sequentially.
- For NSCLC (EGFR wild type) with adenocarcinoma histology
- 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...
- Must have documented negative test results for epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK). Must have no known genomic alterations in ROS proto-oncogene 1 (ROS1). Progressed or...
- Ovarian adenocarcinoma a) Has histologic documentation of epithelial ovarian, primary peritoneal, or fallopian tube cancer that has progressed or relapsed on or after a previous platinum-containing chemotherapy with or...
- Endometrial carcinoma a) Has relapsed, advanced and/or metastatic endometrial carcinoma, who have progressed on or after prior platinum-based chemotherapy with or without immuno-oncology (IO) treatment
- For Cervical carcinoma Has relapsed, advanced and/or metastatic cervical carcinoma, who have progressed on or after prior platinum-based chemotherapy with or without immuno-oncology (IO) treatment
What rules you out
- 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...
- 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...
- people 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...
- 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...
- 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...
- 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...
- 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...
- Participants with active infections requiring systemic treatment, such as severe pneumonia, bacteremia, sepsis.
- Received an investigational drug within 4 weeks, or two half-lives (whichever is longer) prior to first dose of study treatment
- Participants who are pregnant or breastfeeding
- Other conditions that the investigator believes may make the subject not suitable for participating in this clinical trial.
- Participants who have received prior therapy with any ADC targeting EGFR and/or HER3 or containing a topoisomerase 1 inhibitor payload (all dose expansion cohorts with exception of TNBC noted below). Note: For TNBC dose...
- For NSCLC EGFRmut:
- Participants treated with more than two systemic chemotherapies prior to randomization. NOTE: Progression of disease within 12 months after receiving neoadjuvant and adjuvant chemotherapies is considered 1 prior...
- Previously documented EGFR Exon 20 insertion mutations as primary EGFR mutations
- For Triple-Negative Breast Cancer (TNBC, HER2-/HR-): a) Participants treated with more than two systemic chemotherapies prior to randomization. NOTE: Progression of disease within 12 months after receiving neoadjuvant...
- For Esophageal Carcinoma a) Participants received more than 1 prior line of systemic chemotherapy therapy for locally advanced or metastatic disease. NOTE: this limit only applies to prior systemic chemotherapy.
- For Prostate adenocarcinoma: a) Prior treatment with systemic chemotherapy.
- For NSCLC with EGFR WT squamous or adenocarcinoma histology: a) Participants received more than 1 prior line of systemic chemotherapy for locally advanced or metastatic disease
- For Ovarian Carcinoma a) Participants received more than 1 prior line of systemic chemotherapy. Re-treatment with platinum-based chemotherapy is considered one line of therapy. Prior hormonal therapy is permitted.
- For Endometrial Carcinoma a) Participants received more than 1 prior line of systemic chemotherapy. Re-treatment with platinum-based chemotherapy is considered one line of therapy. Prior hormonal therapy is permitted.
- For Cervical Carcinoma a) if received more than 1 prior line of systemic chemotherapy. Re-treatment with platinum-based chemotherapy is considered one line of therapy. Notes: Re-treatment with platinum-based...
The study team makes the final eligibility decision.
Where it's taking place
- Beverly Hills, California, United States
- Duarte, California, United States
- Irvine, California, United States
- Orange, California, United States
- Santa Monica, California, United States
- Aurora, Colorado, United States
- New Haven, Connecticut, United States
- Washington D.C., District of Columbia, United States
- Miami, Florida, United States
- Orlando, Florida, United States
- Port Saint Lucie, Florida, United States
- Chicago, Illinois, United States
- Iowa City, Iowa, United States
- Louisville, Kentucky, United States
- Boston, Massachusetts, United States
- New York, New York, United States
- Greenville, South Carolina, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- Fairfax, Virginia, United States
+ 12 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beverly Hills, California, United States; Duarte, California, United States; Irvine, California, United States; Orange, California, United States; Santa Monica, California, United States; Aurora, Colorado, United States and 26 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.