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 (Jun 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
Treatments studied
Other
Cancer type
Colorectal Cancer
Gastric Cancer
Hepatocellular Carcinoma
Pancreatic Cancer
Cholangiocarcinoma
Esophageal Carcinoma
Tumor Agnostic
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
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.
Frequently asked questions
Is NCT06954077 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior chemotherapy or biological therapy, mitomycin, nitrosourea disqualifies patients from enrollment.
Is there an age limit?
Yes. Patients must be 75 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.
Check if I qualifyRelated pages