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AzTrials

Non Small Cell Lung CancerPhase 1NCT05983432

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

A Phase 1 study testing BL-B01D1 in people with Non Small Cell Lung Cancer and Esophageal Cancer, run by SystImmune Inc. at 37 sites in 5 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
BL-B01D1
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
540 participants
Where
37 sitesin 5 countries
Study dates
8 Aug 2023to 22 Jul 2030
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to 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 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.
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  • 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
  • Sexually active fertile subjects 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 study treatment. An additional contraceptive method, such as a barrier method like a condom is required.
  • Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at screening and must be nonlactating. Female subjects are considered WOCBP unless one of the following criteria are met: documented permanent sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or documented postmenopausal status (defined as 12 months of amenorrhea in a woman >45 years old in the absence of other biological or physiological causes. In addition, females <55 years old must have a serum follicle stimulating hormone (fsh) level > 40 mIU/mL to confirm menopause.
  • For subjects with NSCLC (EGFR mutation):
  • 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 serine-isoleucine mutation in EGFR Exon 20 (ex20S768I), the leucine-glutamine substitution mutation in Exon 21 (ex21L861Q), or the glycine substitution (with alanine, cysteine, or serine) mutation in Exon 18 (ex18G719X) at or after the time of disease diagnosis and prior to initiation of treatment.
  • For Triple-Negative Breast Cancer (TNBC, HER2-/HR-):
  • Histologically or cytologically confirmed and documented locally advanced, recurrent inoperable or metastatic TNBC
  • For Esophageal adenocarcinoma
  • 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 radiological disease progression after one line of fluoropyrimidine and/or platinum-based chemotherapy treatment regimen for locally advanced or metastatic disease.
  • NOTE: Prior therapies such as trastuzumab, zolbetuximab, or IOs are allowed in the study.
  • For Prostate adenocarcinoma
  • Subject has metastatic castration-resistant prostate cancer (mCRPC) after progression on/after an androgen receptor pathway inhibitors (ARPI) treatment, such as abiraterone, enzalutamide, apalutamide and darolutamide.
  • Note: No prior chemotherapy including docetaxel is allowed Prior treatment with lutetium Lu 177 vipivotide tetraxetan (Pluvicto) is allowed. Enrollment will be capped for lutetium Lu 177 vipivotide tetraxetan-naive participants at approximately 20 or participants with prior lutetium Lu 177 vipivotide tetraxetan treatment at approximately 20.
  • 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 locally advanced or metastatic disease with predominantly squamous cell histology
  • 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 locally advanced or metastatic disease with predominantly adenocarcinoma histology
  • 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.
  • Ovarian adenocarcinoma
  • 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 without a PARP inhibitor.
  • Note: participants with platinum-sensitive or platinum resistant recurrent ovarian cancer (PSR) are eligible. However, enrollment will be capped for platinum-sensitive or platinum resistant participants at approximately 20 each.
  • Prior bevacizumab treatment is allowed.
  • Endometrial carcinoma
  • 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

Who cannot join

  • 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)
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  • 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.
  • 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 expansion cohort, participants with prior ADC therapy targeting HER3 and EGFR or a topoisomerase I inhibitor, such as sacituzumab govitecan may be enrolled with Sponsor consultation prior to enrollment
  • 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 systemic chemotherapy
  • Previously documented EGFR Exon 20 insertion mutations as primary EGFR mutations
  • For Triple-Negative Breast Cancer (TNBC, HER2-/HR-):
  • 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 systemic chemotherapy
  • 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:
  • 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 chemotherapy is considered one line of therapy.
  • Note: A participant who does not meet this exclusion criterion may be allowed into the study pending the sponsor's approval, based on current accrual within this dose expansion cohort.
  • Note: There is no limit on the number of prior lines of non-chemotherapy regimens. ADCs with cytotoxic payloads are considered a line of chemotherapy. For any expansion cohorts, if only limited number of patients can be enrolled with 1 prior line of chemotherapy, the Sponsor has the option to allow participants with more than 1 prior line of chemotherapy to be enrolled, upon Sponsor's approval.

Trial locations and contacts

37 sites in 5 countries. Contact the study team or a site near you to ask about taking part.

Tara Barrineau contact

425-453-6841

tara.barrineau@systimmune.com

Tara Barrineau contact

tara.barrineau@systimmune.com

37 sites in 5 countries

United States22 sites, 22 recruiting

  • University of Colorado Cancer Center

    Aurora, Colorado, 80045

    Tejas Patil, tejas.patil@cuanschutz.edu

    Tejas Patil, MD

    Recruiting

  • Beverly Hills Cancer Center

    Beverly Hills, California, 90211

    Afshin Gabayan, eligabayan@bhcancercenter.com

    Afshin Gabayan, MD

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Zofia Piotrowska, zofia.piotrowska@mgh.harvard.edu

    Zofia Piotrowska, MD

    Recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

    Janne Pasi, pasi_janne@dfci.harvard.edu

    Janne Pasi, MD, PhD

    Recruiting

  • Northwestern University Feinberg School of Medicine

    Chicago, Illinois, 60611

    Young Chae, young.chae@northwestern.edu

    Young Chae, MD

    Recruiting

  • City of Hope Cancer Center

    Duarte, California, 91010

    Adam Rock, arock@coh.org

    Adam Rock, MD

    Recruiting

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

    Alexander Spira, alexander.spira@usoncology.com

    Alexander Spira, MD

    Recruiting

  • PRISMA Health/ITOR

    Greenville, South Carolina, 29605

    Jeffery Edenfield, Jeffery.Edenfield@prismahealth.org

    Jeffery Edenfield, MD

    Recruiting

  • Oncology Consultants, P.A.

    Houston, Texas, 77030

    Julio Peguero, jpeguero@oncologyconsultants.com

    Julio Peguero, MD

    Recruiting

  • University of Texas M.D. Anderson Cancer Center

    Houston, Texas, 77030

    Yasir Elamin

    Yasir Elamin, MD

    Recruiting

  • University of Iowa Hospital and Clinics

    Iowa City, Iowa, 52242

    Sneha Phadke, sneha-phadke@uiowa.edu

    Sneha Phadke, MD

    Recruiting

  • Norton Cancer Institute

    Louisville, Kentucky, 40202

    John Hamm, JHamm.Research@nortonhealthcare.org

    John Hamm, MD

    Recruiting

  • Sylvester Comprehensive Cancer Center

    Miami, Florida, 33125

    Gilberto Lopes, gxl405@miami.edu

    Gilberto Lopes, MD

    Recruiting

  • Sarah Cannon - Tennessee Oncology

    Nashville, Tennessee, 37203

    Melissa Johnson, mjohnson@tnonc.com

    Melissa Johnson, MD

    Recruiting

  • Yale University, Yale Cancer Center

    New Haven, Connecticut, 06520

    Scott Gettinger, scott.gettinger@yale.edu

    Scott Gettinger, MD

    Recruiting

  • Memorial Sloan Kettering Cancer Center Head Neck Services

    New York, New York, 10065

    Helena Yu, yuh@mskcc.org

    Helena Yu, MD

    Recruiting

  • University of California Irvine Medical Center

    Orange, California, 92868

    Cathleen Park, cathleep@hs.uci.edu

    Cathleen Park, MD

    Recruiting

  • Sara Cannon Research Institute Lake Nona

    Orlando, Florida, 32827

    Cesar Perez Batista, cesar.perezbatista@flcancer.com

    Cesar Perez Batista, MD

    Recruiting

  • Hematology - Oncology Associates of the Treasure Coast

    Port Saint Lucie, Florida, 34952

    Nicholas Iannotti, niannotti@hemoncfl.com

    Nicholas Iannotti, MD

    Recruiting

  • UCLA Santa Monica

    Santa Monica, California, 90404

    Jonathan Goldman, MD, jwgoldman@mednet.ucla.edu

    Jonathan Goldman, MD

    Recruiting

  • University of Washington Fred Hutchinson

    Seattle, Washington, 98109

    Christina Baik, cbaik2@u.washington.edu

    Christina Baik, MD

    Recruiting

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

    Stephen Liu, stephen.v.liu@gunet.georgetown.edu

    Stephen Liu, MD

    Recruiting

Other trials in United States

Spain8 sites, 8 recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

    Enriqueta Felip Font, efelip@vhio.net

    Enriqueta Felip Font, MD

    Recruiting

  • Hospital de la Santa Creu I Sant Pau

    Barcelona, 8041

    Margarita Majem Tarruella, mmajem@santpau.cat

    Margarita Majem Tarruella, MD

    Recruiting

  • Hospital Beata María Ana

    Madrid, 28007

    Javier Cortes, javier.cortes@maj3.health

    Javier Cortes, MD

    Recruiting

  • START Madrid / Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040

    Ester Garcia Lorenzo, ester.garcia@startmadrid.com

    Ester Garcia Lorenzo, MD

    Recruiting

  • Hospital Universitario 12 De Octubre

    Madrid, 28041

    Santiago Ponce Aix, santiago.ponce@oncosur.org

    Santiago Ponce Aix, MD

    Recruiting

  • START Madrid / Centro Integral Oncologico Clara Campal

    Madrid, 28050

    Ramon Yarza Barrio, Ramon.yarza@startmadrid.com

    Ramon Yarza Barrio, MD

    Recruiting

  • START Rioja

    Piqueras, 26006

    Maria Jose de Miguel Luken, maria.demiguel@startrioja.com

    Maria Jose de Miguel Luken, MD

    Recruiting

  • Hospital Universitario Virgen Macarena

    Seville, 41009

    David Vicente Baz, david.vbaz@gmail.com

    David Vicente Baz, MD

    Recruiting

Other trials in Spain

France4 sites, 4 recruiting

  • Centre Léon Bérard

    Lyon, 69373

    Aurélie Swalduz, aurelie.swalduz@lyon.unicancer.fr

    Aurélie Swalduz, MD

    Recruiting

  • Groupe Hospitalier Pitie-Salpetriere

    Paris, 75013

    Johanna Wassermann, johanna.wassermann@aphp.fr

    Johanna Wassermann, MD

    Recruiting

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

    Saint-Herblain, 44805

    Sandrine Hiret, sandrine.hiret@ico.unicancer.fr

    Sandrine Hiret, MD

    Recruiting

  • Institut Gustave Roussy

    Villejuif, 94800

    Anas Gazzah, anas.gazzah@gustaveroussy.fr

    Anas Gazzah, MD

    Recruiting

Other trials in France

Italy2 sites, 2 recruiting

  • Fondazione del Piemonte per l'Oncologia IRCC Candiolo

    Candiolo, 10060

    Vanesa Gregorc, vanesa.gregorc@ircc.it

    Vanesa Gregorc, MD

    Recruiting

  • IRCCS Istituto Clinico Humanitas, Cancer Center

    Rozzano, 20089

    Matteo Simonelli, matteo.simonelli@hunimed.eu

    Matteo Simonelli, MD

    Recruiting

Other trials in Italy

Japan1 site, 1 recruiting

  • National Cancer Center Hospital

    Chūōku, 104-0045

    Noboru Yamamoto, nbryamam@ncc.go.jp

    Noboru Yamamoto, MD

    Recruiting

Other trials in Japan

About this study

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.

Read the detailed 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.

Being tested
BL-B01D1
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Esophageal Neoplasms, Small Cell Lung Carcinoma, Nasopharyngeal Neoplasms, Squamous Cell Carcinoma of Head and Neck, Ovarian Neoplasms, Endometrial Neoplasms, Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BL-B01D1Drug

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

Study groups in NCT05983432
Study groupRoleWhat they receive
BL-B01D1 administered Day 1 and Day 8 per cycleExperimentalBL-B01D1 will be administered on Day 1 and Day 8 by intravenous infusion every 3 weeks
Receives: Drug: BL-B01D1
BL-B01D1 administered Day 1 per cycleExperimentalBL-B01D1 will be administered on Day 1 via by intravenous infusion every 3 weeks
Receives: Drug: BL-B01D1

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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,

    Measured: One year

  2. 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)

    Measured: One year

  3. Participants with abnormal physical examination findings

    Measure the number of participants with abnormal physical examination findings.

    Measured: One year

  4. 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)

    Measured: One year

  5. Participants with abnormal ECG reading

    Measure the number of participants with abnormal ECG parameters

    Measured: One year

  6. Participants with abnormal lab results

    Measure the number of participants with abnormal clinical laboratory values

    Measured: One year

  7. 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.

    Measured: One year

Secondary outcomes (18)

  1. Cmax of BL-B01D1

    Calculate maximum (peak) observed concentration of BL-B01D1

    Measured: One year

  2. Cmax of anti-EGFR×HER3 antibody

    Calculate maximum (peak) observed concentration of anti-EGFR×HER3 antibody

    Measured: One year

  3. Cmax of free payload ED-04

    Calculate maximum (peak) observed concentration of free payload ED-04

    Measured: One year

  4. Tmax of BL-B01D1

    Calculate time of maximum observed concentration of BL-B01D1

    Measured: One year

  5. Tmax of anti-EGFR×HER3 antibody

    Calculate time of maximum observed concentration of anti-EGFR×HER3 antibody

    Measured: One year

  6. Tmax of free payload ED-04

    Calculate time of maximum observed concentration of free payload ED-04

    Measured: One year

  7. AUC(0-8) of BL-B01D1

    Calculate area under the serum concentration-time curve of BL-B01D1 from time 0 to 8 hours

    Measured: One year

  8. 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

    Measured: One year

  9. 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

    Measured: One year

  10. AUC(last) of BL-B01D1

    Calculate area under the serum concentration-time curve up of BL-B01D1 to the last quantifiable time

    Measured: One year

  11. 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

    Measured: One year

  12. 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

    Measured: One year

  13. Overall Response Rate (ORR)

    To assess the clinical efficacy of BL-B01D1 as measured by ORR using RECIST criteria v 1.1

    Measured: One year

  14. Disease Control Rate (DCR)

    To assess the clinical efficacy of BL-B01D1 as measured by DCR using RECIST criteria v 1.1

    Measured: One year

  15. Time To Response (TTR)

    To assess the clinical efficacy of BL-B01D1 as measured by TTR using RECIST criteria v 1.1

    Measured: One year

  16. Progression-Free Survival (PFS),

    To assess the clinical efficacy of BL-B01D1 as measured by PFS using RECIST criteria v 1.1

    Measured: One year

  17. Overall Survival (OS).

    To assess the clinical efficacy of BL-B01D1 as measured by OS using RECIST criteria v 1.1

    Measured: One year

  18. Antitumor Activity

    To investigate the antitumor activity of BL-B01D1 as evaluated using RECIST Version 1.1

    Measured: One year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2023
  2. Study start8 Aug 2023
  3. Primary completion20 Apr 2030 (estimated)
  4. Study completion22 Jul 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
540 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05983432
Sponsor's protocol ID
BL-B01D1-LUNG-101
Status last verified
Sep 2026
First submitted
12 Jul 2023
Last updated
21 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BL-B01D1 in people with Non Small Cell Lung Cancer and Esophageal Cancer, run by SystImmune Inc. at 37 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 42 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in United States, Spain, France, Italy, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Tara Barrineau (425-453-6841, tara.barrineau@systimmune.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Participants with Dose-limiting toxicities (time frame: One year). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05983432.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.

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