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 (Jun 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
Treatments studied
Other
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)
Demographics
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
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07021066 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior anthracycline disqualifies patients from enrollment.
Does this trial require CLDN18?
Yes, CLDN18 expression by IHC (1+) is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 85 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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