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 (Jun 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
Treatments studied
Other
Cancer type
Non-Small Cell Lung Carcinoma
Small Cell Lung Cancer
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 →Frequently asked questions
Is NCT05983432 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior systemic chemotherapy, systemic chemotherapy, systemic chemotherapy disqualifies patients from enrollment.
Does this trial require EGFR?
Yes, EGFR exon 19 deletion is a required biomarker for enrollment.
Does this trial require EGFR?
Yes, EGFR L858R is a required biomarker for enrollment.
Does this trial require EGFR?
Yes, EGFR S768I is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify