Actively Recruiting
Evaluate BL-B01D1 in Patients With Metastatic or Unresectable Non-Small Cell Lung Cancer (NSCLC) and Other Solid Tumors
Led by SystImmune Inc. · Updated on 2026-01-29
470
Participants Needed
39
Research Sites
241 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Evaluate BL-B01D1 in Patients With Metastatic or Unresectable Non-Small Cell Lung Cancer (NSCLC) and Other Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and agreed to follow study requirements
- Any gender
- Age 18 years or older
- Life expectancy of at least 3 months
- Histologically confirmed incurable, locally advanced or metastatic epithelial cancer, including NSCLC, HER2- breast cancer, esophageal cancer, SCLC, nasopharyngeal cancer, and head and neck squamous cell carcinoma
- Documented HER2 negative breast cancer with prior chemotherapy and, if applicable, PD-1/PD-L1 inhibitor treatment
- For triple-negative breast cancer, prior PARP inhibitors if BRCA mutation present and sacituzumab govitecan as second line treatment; HER2 low must have received trastuzumab deruxtecan
- Agree to provide tumor tissue samples within 2 years or fresh biopsy if unavailable
- At least one measurable lesion based on RECIST V1.1 (except prostate adenocarcinoma cohort with bone metastasis)
- Eastern Cooperative Oncology Group performance status 0 to 1
- Previous treatment toxicity resolved to grade 1 or below
- No serious cardiac dysfunction, left ventricular ejection fraction 50% or higher
- Adequate blood marrow, liver, kidney, and coagulation function
- Urinary protein level less than or equal to 2+ or 1000 mg/24 hours
- Use of highly effective contraception during and after study as specified
- Women of childbearing potential must have negative pregnancy test and be nonlactating
- Specific genetic mutations required for NSCLC with EGFR mutation
- Confirmed locally advanced or metastatic triple-negative breast cancer
- Specific prior treatment and progression criteria for esophageal, prostate, NSCLC, ovarian, endometrial, and cervical cancers as detailed in the protocol
You will not qualify if you...
- Recent chemotherapy, biological therapy, immunotherapy, radiotherapy, targeted therapy, or major surgery within specified time frames before dosing
- Severe heart disease or history of serious cardiac events
- Prolonged QT interval or significant heart conduction abnormalities
- Active autoimmune or inflammatory diseases requiring systemic treatment
- Other malignancies within 5 years except certain skin cancers
- Poorly controlled hypertension
- Grade 3 lung disease or history of interstitial lung disease or pneumonitis
- Recent unstable thrombotic events
- Active or untreated central nervous system tumors or metastases unless stable
- Allergies to recombinant or chimeric antibodies or study drug components
- History of stem cell transplantation
- Excessive prior anthracycline treatment
- Grade 2 or higher hypokalemia
- Active infections including HIV, hepatitis B or C
- Recent investigational drug use
- Pregnancy or breastfeeding
- Prior therapy with ADC targeting EGFR/HER3 or topoisomerase 1 inhibitor payloads (with exceptions)
- Excessive prior systemic chemotherapy depending on cancer type
- Other conditions deemed unsuitable by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 39 locations
1
Beverly Hills Cancer Center
Beverly Hills, California, United States, 90211
Actively Recruiting
2
City of Hope Cancer Center
Duarte, California, United States, 91010
Actively Recruiting
3
Chao Family Comprehensive Cancer Care and Ambulatory Care
Irvine, California, United States, 92612
Not Yet Recruiting
4
Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, United States, 92612
Not Yet Recruiting
5
University of California Irvine Medical Center
Orange, California, United States, 92868
Actively Recruiting
6
UCLA Santa Monica
Santa Monica, California, United States, 90404
Actively Recruiting
7
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
Actively Recruiting
8
Yale University, Yale Cancer Center
New Haven, Connecticut, United States, 06520
Actively Recruiting
9
Georgetown University Medical Center
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
10
Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33125
Actively Recruiting
11
Sara Cannon Research Institute Lake Nona
Orlando, Florida, United States, 32827
Actively Recruiting
12
Hematology - Oncology Associates of the Treasure Coast
Port Saint Lucie, Florida, United States, 34952
Actively Recruiting
13
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
Actively Recruiting
14
University of Iowa Hospital and Clinics
Iowa City, Iowa, United States, 52242
Actively Recruiting
15
Norton Cancer Institute
Louisville, Kentucky, United States, 40202
Actively Recruiting
16
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
17
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
18
Memorial Sloan Kettering Cancer Center Head Neck Services
New York, New York, United States, 10065
Actively Recruiting
19
PRISMA Health/ITOR
Greenville, South Carolina, United States, 29605
Actively Recruiting
20
Sarah Cannon - Tennessee Oncology
Nashville, Tennessee, United States, 37203
Actively Recruiting
21
Oncology Consultants, P.A.
Houston, Texas, United States, 77030
Actively Recruiting
22
University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
23
Virginia Cancer Specialists
Fairfax, Virginia, United States, 22031
Actively Recruiting
24
University of Washington Fred Hutchinson
Seattle, Washington, United States, 98109
Actively Recruiting
25
Centre Léon Bérard
Lyon, France, 69373
Actively Recruiting
26
Groupe Hospitalier Pitie-Salpetriere
Paris, France, 75013
Actively Recruiting
27
Institut de Cancerologie de Ouest (ICO) - Saint-Herblain
Saint-Herblain, France, 44805
Actively Recruiting
28
Institut Gustave Roussy
Villejuif, France, 94800
Actively Recruiting
29
Fondazione del Piemonte per l'Oncologia IRCC Candiolo
Candiolo, Italy, 10060
Actively Recruiting
30
IRCCS Istituto Clinico Humanitas, Cancer Center
Rozzano, Italy, 20089
Actively Recruiting
31
National Cancer Center Hospital
Chūōku, Japan, 104-0045
Actively Recruiting
32
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Actively Recruiting
33
Hospital de la Santa Creu I Sant Pau
Barcelona, Spain, 8041
Actively Recruiting
34
Hospital Beata María Ana
Madrid, Spain, 28007
Actively Recruiting
35
START Madrid / Hospital Universitario Fundacion Jimenez Diaz
Madrid, Spain, 28040
Actively Recruiting
36
Hospital Universitario 12 De Octubre
Madrid, Spain, 28041
Actively Recruiting
37
START Madrid / Centro Integral Oncologico Clara Campal
Madrid, Spain, 28050
Actively Recruiting
38
START Rioja
Piqueras, Spain, 26006
Not Yet Recruiting
39
Hospital Universitario Virgen Macarena
Seville, Spain, 41009
Actively Recruiting
Research Team
T
Tara Barrineau
CONTACT
C
Colandra McDowell
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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