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

Status: Recruiting
Location: See all (22) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 1\) Signed the informed consent voluntarily and agreed to follow the program requirements 2) Either sex 3) Age: ≥18 years 4) Has a life expectancy of ≥3 months 5) 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 6) 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.

• 7\) Has at least one measurable lesion based on RECIST V1.1 8) Has an Eastern Cooperative Oncology Group performance status (ECOG PS) 0 to 1 9) 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.) 10) Has no serious cardiac dysfunction, left ventricular ejection fraction ≥50% 11) 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) 12) Coagulation function: international normalized ratio (INR) ≤1.5×ULN, and activated partial thromboplastin time (APTT) ≤1.5 ULN 13) Urinary protein ≤2+ or ≤1000mg/24 hours 14) 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.

• 15\) 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.

• 16\) For subjects with NSCLC:

• 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 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.

• 17\) For Triple-Negative Breast Cancer (TNBC, HER2-/HR-):

• a) Histologically or cytologically confirmed and documented locally advanced, recurrent inoperable or metastatic TNBC

Locations
United States
California
Beverly Hills Cancer Center
RECRUITING
Beverly Hills
City of Hope Cancer Center
RECRUITING
Duarte
University of California Irvine Medical Center
RECRUITING
Orange
UCLA Santa Monica
RECRUITING
Santa Monica
Colorado
University of Colorado Cancer Center
RECRUITING
Aurora
Connecticut
Yale University, Yale Cancer Center
RECRUITING
New Haven
Washington, D.c.
Georgetown University Medical Center
RECRUITING
Washington D.c.
Florida
Sylvester Comprehensive Cancer Center
RECRUITING
Miami
Sara Cannon Research Institute Lake Nona
RECRUITING
Orlando
Hematology - Oncology Associates of the Treasure Coast
RECRUITING
Port Saint Lucie
Iowa
University of Iowa Hospital and Clinics
RECRUITING
Iowa City
Illinois
Northwestern University Feinberg School of Medicine
RECRUITING
Chicago
Kentucky
Norton Cancer Institute
RECRUITING
Louisville
Massachusetts
Dana-Farber Cancer Institute
RECRUITING
Boston
Massachusetts General Hospital
RECRUITING
Boston
New York
Memorial Sloan Kettering Cancer Center Head Neck Services
RECRUITING
New York
South Carolina
PRISMA Health/ITOR
RECRUITING
Greenville
Tennessee
Sarah Cannon - Tennessee Oncology
RECRUITING
Nashville
Texas
Oncology Consultants, P.A.
RECRUITING
Houston
University of Texas M.D. Anderson Cancer Center
RECRUITING
Houston
Virginia
Virginia Cancer Specialists
RECRUITING
Fairfax
Washington
University of Washington Fred Hutchinson
RECRUITING
Seattle
Contact Information
Primary
Tara Barrineau
tara.barrineau@systimmune.com
425-453-6841
Backup
Colandra McDowell
colandra.mcdowell@systimmune.com
Time Frame
Start Date: 2023-08-08
Estimated Completion Date: 2028-03-21
Participants
Target number of participants: 260
Treatments
Experimental: BL-B01D1 administered Day 1 and Day 8 per cycle
BL-B01D1 will be administered on Day 1 and Day 8 by intravenous infusion every 3 weeks
Experimental: BL-B01D1 administered Day 1 per cycle
BL-B01D1 will be administered on Day 1 via by intravenous infusion every 3 weeks
Sponsors
Leads: SystImmune Inc.

This content was sourced from clinicaltrials.gov