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.
• 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