OncoMatch/Clinical Trials/NCT07021066
Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M05D1 in Subjects With Solid Tumors
Is NCT07021066 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies BL-M05D1 for gastric adenocarcinoma.
Treatment: BL-M05D1 — The objective of this study is to evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M05D1 in Subjects with Advanced or Metastatic Solid Tumors.
Check if I qualifyExtracted eligibility criteria
Cancer type
Gastric Cancer
Pancreatic Cancer
Esophageal Carcinoma
Cholangiocarcinoma
Tumor Agnostic
Biomarker criteria
Required: CLDN18 expression by IHC (1+) (1+)
Other solid tumors not specified above may be included IF they have documented CLDN18.2 expression by IHC (1+)
Allowed: HER2 (ERBB2) positive
Subjects with CLDN18.2, human epidermal growth factor receptor 2 (HER2), PD-L1 and/or microsatellite instability high (MSI-H)/ mismatch repair deficiency (dMMR) positive tumors must have received targeted treatment in their prior lines of therapy
Allowed: PD-L1 (CD274) positive
Subjects with CLDN18.2, human epidermal growth factor receptor 2 (HER2), PD-L1 and/or microsatellite instability high (MSI-H)/ mismatch repair deficiency (dMMR) positive tumors must have received targeted treatment in their prior lines of therapy
Allowed: MSH2 deficiency (dMMR)
Subjects with CLDN18.2, human epidermal growth factor receptor 2 (HER2), PD-L1 and/or microsatellite instability high (MSI-H)/ mismatch repair deficiency (dMMR) positive tumors must have received targeted treatment in their prior lines of therapy
Allowed: MSH6 deficiency (dMMR)
Subjects with CLDN18.2, human epidermal growth factor receptor 2 (HER2), PD-L1 and/or microsatellite instability high (MSI-H)/ mismatch repair deficiency (dMMR) positive tumors must have received targeted treatment in their prior lines of therapy
Allowed: MLH1 deficiency (dMMR)
Subjects with CLDN18.2, human epidermal growth factor receptor 2 (HER2), PD-L1 and/or microsatellite instability high (MSI-H)/ mismatch repair deficiency (dMMR) positive tumors must have received targeted treatment in their prior lines of therapy
Allowed: PMS2 deficiency (dMMR)
Subjects with CLDN18.2, human epidermal growth factor receptor 2 (HER2), PD-L1 and/or microsatellite instability high (MSI-H)/ mismatch repair deficiency (dMMR) positive tumors must have received targeted treatment in their prior lines of therapy
Allowed: NTRK1 fusion
Subjects with HER2 overexpression, NTRK fusions, KRAS mutations, IDH1 mutations, FGFR2 fusions, BRAF mutations and/or MSI-H/dMMR positive tumors must have received targeted treatment in their prior lines of therapy
Allowed: NTRK2 fusion
Subjects with HER2 overexpression, NTRK fusions, KRAS mutations, IDH1 mutations, FGFR2 fusions, BRAF mutations and/or MSI-H/dMMR positive tumors must have received targeted treatment in their prior lines of therapy
Allowed: NTRK3 fusion
Subjects with HER2 overexpression, NTRK fusions, KRAS mutations, IDH1 mutations, FGFR2 fusions, BRAF mutations and/or MSI-H/dMMR positive tumors must have received targeted treatment in their prior lines of therapy
Allowed: KRAS mutation
Subjects with HER2 overexpression, NTRK fusions, KRAS mutations, IDH1 mutations, FGFR2 fusions, BRAF mutations and/or MSI-H/dMMR positive tumors must have received targeted treatment in their prior lines of therapy
Allowed: IDH1 mutation
Subjects with HER2 overexpression, NTRK fusions, KRAS mutations, IDH1 mutations, FGFR2 fusions, BRAF mutations and/or MSI-H/dMMR positive tumors must have received targeted treatment in their prior lines of therapy
Allowed: FGFR2 fusion
Subjects with HER2 overexpression, NTRK fusions, KRAS mutations, IDH1 mutations, FGFR2 fusions, BRAF mutations and/or MSI-H/dMMR positive tumors must have received targeted treatment in their prior lines of therapy
Allowed: BRAF mutation
Subjects with HER2 overexpression, NTRK fusions, KRAS mutations, IDH1 mutations, FGFR2 fusions, BRAF mutations and/or MSI-H/dMMR positive tumors must have received targeted treatment in their prior lines of therapy
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: anthracycline
Subjects with known treatment with anthracyclines with a cumulative dose exceeding 360 mg/m2
Lab requirements
Blood counts
ANC ≥1.5×10^9/L, platelet count ≥100×10^9/L, hemoglobin ≥9.0 g/dL
Kidney function
Creatinine clearance ≥60 mL/min (Cockcroft-Gault) or eGFR ≥50 mL/min/1.73 m2 (CKD-EPI)
Liver function
Total bilirubin ≤1.5×ULN (≤3×ULN for Gilbert's syndrome or liver metastasis), AST/ALT without liver metastasis ≤3.0×ULN, AST/ALT with liver metastasis ≤5.0×ULN
Cardiac function
left ventricular ejection fraction ≥50%
Has adequate organ function before enrollment, defined as: Marrow function: Absolute neutrophil count (ANC) ≥1.5×10^9/L, platelet count (PLT) ≥100×10^9/L, hemoglobin (Hb) ≥9.0 g/dL; Hepatic function: Total bilirubin (TBIL) ≤1.5×ULN (≤3×ULN for subjects with Gilbert's syndrome or liver metastasis at baseline), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) without liver metastasis ≤3.0×ULN, AST and ALT with liver metastasis ≤5.0×ULN; Renal function: Creatinine (Cr) clearance ≥60 mL/min (Cockcroft-Gault equation) or estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73 m2 (Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] equation)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Mayo Clinic Cancer Center- Phoenix · Phoenix, Arizona
- HonorHealth · Scottsdale, Arizona
- University of Colorado Health · Aurora, Colorado
- Yale Cancer Center · New Haven, Connecticut
- Ochsner Medical Center · New Orleans, Louisiana
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