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

Last updated: July 19, 2024
Sponsor: SystImmune Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Nasopharyngeal Cancer

Breast Cancer

Non-small Cell Lung Cancer

Treatment

BL-B01D1

Clinical Study ID

NCT05983432
BL-B01D1-LUNG-101
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Sign informed consent

  2. Expected survival > or = 3months

  3. Has histologically documented, incurable, locally advanced or metastatic epithelialorigin malignant cancer, priority to include the following tumor types: Non-SmallCell 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

  7. Toxicity of previous antitumor therapy has returned to level ≤1 as defined byNCI-CTCAE V5.0 (except for asymptomatic laboratory abnormalities such as elevatedALP, hyperuricemia, elevated serum or plasma amylase/lipase, and elevated bloodglucose; except for toxicity that the investigator determined to have no safetyrisk, such as alopecia, grade 2 peripheral neurotoxicity, hypothyroidism stabilizedby hormone replacement therapy, etc.)

  8. Has no serious cardiac dysfunction, left ventricular ejection fraction ≥50%.

  9. Has adequate organ function before registration

  10. Coagulation function: international normalized ratio (INR) ≤1.5×ULN, and activatedpartial thromboplastin time (APTT) ≤1.5 ULN

  11. Urinary protein ≤2+ or ≤1000mg/24 hours

  12. For premenopausal women with childbearing potential, a pregnancy test must be takenwithin 7 days prior to the start of treatment. Serum or urine pregnancy must benegative and must be non-lactating

  13. Must agree to use adequate barrier contraceptive measures during the treatment and 6months after the end of treatment for all subjects (regardless of gender)

Exclusion

Exclusion Criteria:

  1. Chemotherapy, biological therapy, immunotherapy, radical radiotherapy, majorsurgery, targeted therapy and other anti-tumor therapy within 4 weeks or 5half-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, andpulmonary embolism requiring therapeutic intervention within the previous 6 monthsbefore screening

  8. Symptoms of active central nervous system metastasis

  9. Subjects who have a history of allergies to recombinant humanized antibodies orhuman 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 activeHepatitis C virus infection

  12. Subjects with active infections requiring systemic treatment

  13. Participated in another clinical trial within 4 weeks prior to participating in thestudy

  14. Other conditions that the investigator believes that it is not suitable forparticipating in this clinical trial

  15. Subjects with prolonged QT interval (QTc >470 msec), complete left bundle branchblock, Grade 3 atrioventricular block

  16. Has received treatment with anthracyclines with a cumulative dose exceeding 360mg/m2

Study Design

Total Participants: 260
Treatment Group(s): 1
Primary Treatment: BL-B01D1
Phase: 1
Study Start date:
August 08, 2023
Estimated Completion Date:
March 21, 2028

Study 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.

Connect with a study center

  • SystImmune Recruiting Site

    Madrid, 28040
    Spain

    Active - Recruiting

  • SystImmune Recruiting Site

    Duarte, California 91010
    United States

    Site Not Available

  • SystImmune Recruiting Site

    Orange, California 92868
    United States

    Active - Recruiting

  • SystImmune Recruiting Site

    Boulder, Colorado 80045
    United States

    Active - Recruiting

  • SystImmune Recruiting Site

    Miami, Florida 33125
    United States

    Active - Recruiting

  • Hematology/Oncology Associates of Treasure Coast

    Port Saint Lucie, Florida 34952
    United States

    Active - Recruiting

  • SystImmune Recruiting Center

    Port Saint Lucie, Florida 34952
    United States

    Active - Recruiting

  • SystImmune Recruiting Site

    Port Saint Lucie, Florida 34952
    United States

    Active - Recruiting

  • SystImmune Recruiting Site

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • SystImmune Recruiting Site

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • SystImmune Recruiting Site

    Hackensack, New Jersey 07601
    United States

    Site Not Available

  • SystImmune Recruiting Center

    New York, New York 10065
    United States

    Active - Recruiting

  • SystImmune Recruiting Site

    New York, New York 10065
    United States

    Active - Recruiting

  • Prisma Health Cancer Institute

    Greenville, South Carolina 29605
    United States

    Active - Recruiting

  • SystImmune Recruiting Center

    Greenville, South Carolina 29605
    United States

    Active - Recruiting

  • SystImmune Recruiting Site

    Greenville, South Carolina 29605
    United States

    Active - Recruiting

  • SystImmune Recruiting Center

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • SystImmune Recruiting Site

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • SystImmune Recruiting Center

    Dallas, Texas 75230
    United States

    Active - Recruiting

  • SystImmune Recruiting Site

    Dallas, Texas 75230
    United States

    Active - Recruiting

  • SystImmune Recruiting Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • SystImmune Recruiting Site

    Houston, Texas 77030
    United States

    Active - Recruiting

  • SystImmune Recruiting Site

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

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