OncoMatch/Clinical Trials/NCT05983432
Evaluate BL-B01D1 in Patients With Metastatic or Unresectable Non-Small Cell Lung Cancer (NSCLC) and Other Solid Tumors
Is NCT05983432 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies BL-B01D1 for non small cell lung cancer.
Treatment: BL-B01D1 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Small Cell Lung Cancer
Non-Small Cell Lung Carcinoma
Breast Carcinoma
Esophageal Carcinoma
Head and Neck Squamous Cell Carcinoma
Prostate Cancer
Ovarian Cancer
Endometrial Cancer
Cervical Cancer
Triple-Negative Breast Cancer
Biomarker criteria
Required: EGFR exon 19 deletion
EGFR TKI-sensitizing deletion mutation in EGFR Exon 19 (ex19del)
Required: EGFR L858R
leucin-arginine substitution point mutation in EGFR Exon 21 (ex21L858R)
Required: EGFR S768I
serine-isoleucine mutation in EGFR Exon 20 (ex20S768I)
Required: EGFR L861Q
leucine-glutamine substitution mutation in Exon 21 (ex21L861Q)
Required: EGFR G719X
glycine substitution (with alanine, cysteine, or serine) mutation in Exon 18 (ex18G719X)
Required: EGFR wild-type
Must have documented negative test results for epidermal growth factor receptor (EGFR)
Required: ALK wild-type
Must have documented negative test results for...anaplastic lymphoma kinase (ALK)
Required: ROS1 wild-type
Must have no known genomic alterations in ROS proto-oncogene 1 (ROS1)
Required: HER2 (ERBB2) negative (by immunohistochemistry [IHC], score of 0 or 1) (IHC 0 or 1)
HER2 negative (by immunohistochemistry [IHC], score of 0 or 1)
Required: HER2 (ERBB2) negative (IHC score of 0 to 2) (IHC 0 to 2)
HER2 negative (IHC score of 0 to 2)
Allowed: BRCA1 mutation
must have received PARP inhibitors if a BRCA mutation is present
Allowed: BRCA2 mutation
must have received PARP inhibitors if a BRCA mutation is present
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic chemotherapy
Exception: disease progression within 12 months after neoadjuvant/adjuvant chemotherapy is considered 1 prior systemic chemotherapy
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
Cannot have received: systemic chemotherapy
Participants received more than 1 prior line of systemic chemotherapy therapy for locally advanced or metastatic disease
Cannot have received: systemic chemotherapy
Prior treatment with systemic chemotherapy
Lab requirements
Blood counts
ANC ≥1.2×10^9 /L, Platelet count ≥100×10^9 /L, Hemoglobin (Hb) ≥90 g/L
Kidney function
Creatinine clearance ≥50 mL/min (Cockcroft and Gault equation)
Liver function
Total bilirubin ≤1.5 ULN, AST and ALT without liver metastasis ≤2.5 ULN, AST and ALT with liver metastasis ≤5.0 ULN
Cardiac function
No serious cardiac dysfunction, left ventricular ejection fraction ≥50%
Has adequate organ function before registration, defined as: a) Marrow Function: Absolute neutrophil count (ANC) ≥1.2×10^9 /L, Platelet count ≥100×10^9 /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)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Beverly Hills Cancer Center · Beverly Hills, California
- City of Hope Cancer Center · Duarte, California
- Chao Family Comprehensive Cancer Care and Ambulatory Care · Irvine, California
- Chao Family Comprehensive Cancer Center and Ambulatory Care · Irvine, California
- University of California Irvine Medical Center · Orange, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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