OncoMatch/Clinical Trials/NCT06954077
A Study of BL-M09D1 in Patients With Locally Advanced or Metastatic Gastrointestinal Tumors and Other Solid Tumors
Is NCT06954077 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies BL-M09D1 for gastrointestinal tumor.
Treatment: BL-M09D1 — This study is an open, multicenter, dose-escalation and expanded-enrollment, nonrandomized phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of BL-M09D1 for injection in patients with locally advanced or metastatic gastrointestinal tumors and other solid tumors.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Gastric Cancer
Hepatocellular Carcinoma
Pancreatic Cancer
Cholangiocarcinoma
Esophageal Carcinoma
Tumor Agnostic
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: standard treatment
solid tumors that failed standard treatment
Cannot have received: chemotherapy or biological therapy
Anti-tumor therapy such as chemotherapy or biological therapy has been used within 4 weeks or 5 half-lives before the first dose
Cannot have received: mitomycin (mitomycin)
Mitomycin ... administered within 6 weeks before the first dose
Cannot have received: nitrosourea (nitrosoureas)
nitrosoureas were administered within 6 weeks before the first dose
Cannot have received: oral antineoplastic drugs (fluorouracil)
Oral drugs such as fluorouracil
Cannot have received: anthracycline
Exception: cumulative dose > 360 mg/m2 in previous (new) adjuvant therapy
Anthracycline cumulative dose > 360 mg/m2 in previous (new) adjuvant therapy
Lab requirements
Blood counts
Toxicity of previous antineoplastic therapy has returned to ≤ grade 1 defined by NCI-CTCAE v5.0
Kidney function
Liver function
Cardiac function
No severe cardiac dysfunction, left ventricular ejection fraction ≥50%
Organ function level must meet the requirements; No severe cardiac dysfunction, left ventricular ejection fraction ≥50%; Toxicity of previous antineoplastic therapy has returned to ≤ grade 1 defined by NCI-CTCAE v5.0
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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