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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.

Phase 1RecruitingSichuan Baili Pharmaceutical Co., Ltd.NCT06954077Data as of May 2026

Treatment: BL-M09D1This 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.

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Extracted 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

Min 1 prior line

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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