Status:
RECRUITING
A Study of BL-M09D1 in Patients With Locally Advanced or Metastatic Gastrointestinal Tumors and Other Solid Tumors
Lead Sponsor:
Sichuan Baili Pharmaceutical Co., Ltd.
Collaborating Sponsors:
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Conditions:
Gastrointestinal Tumor
Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- Voluntarily sign the informed consent and follow the requirements of the protocol;
- No gender limit;
- Age: ≥18 years old and ≤75 years old (phase Ia); ≥18 years old (phase Ib);
- Expected survival time ≥3 months;
- Pathologically and/or cytologically confirmed locally advanced or metastatic gastrointestinal tumors and other solid tumors that failed standard treatment;
- Consent to provide archival tumor tissue samples or fresh tissue samples from primary or metastatic lesions within 2 years;
- Must have at least one measurable lesion according to RECIST v1.1 definition;
- ECOG 0 or 1;
- Toxicity of previous antineoplastic therapy has returned to ≤ grade 1 defined by NCI-CTCAE v5.0;
- No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
- Organ function level must meet the requirements;
- Coagulation function: international normalized ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5ULN;
- Urine protein ≤2+ or ≤1000mg/24h;
- For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before the initiation of treatment, serum pregnancy must be negative, and must be non-lactating; All enrolled patients (regardless of male or female) should use adequate barrier contraception during the whole treatment cycle and for 6 months after the end of treatment;
- Participants were able and willing to comply with protocol-specified visits, treatment plans, laboratory tests, and other study-related procedures.
Exclusion
- Anti-tumor therapy such as chemotherapy or biological therapy has been used within 4 weeks or 5 half-lives before the first dose; Mitomycin and nitrosoureas were administered within 6 weeks before the first dose; Oral drugs such as fluorouracil;
- History of severe heart disease;
- QT prolongation, complete left bundle branch block, III degree atrioventricular block;
- Active autoimmune and inflammatory diseases;
- Other malignant tumors diagnosed within 5 years before the first dose;
- Unstable thrombotic events requiring therapeutic intervention within 6 months before the first dose;
- Poorly controlled hypertension;
- Patients with poor glycemic control;
- History of ILD requiring steroid therapy, or current ILD or ≥ grade 2 radiation pneumonitis;
- Complicated pulmonary diseases leading to clinically severe respiratory function impairment;
- Symptoms of active central nervous system metastasis;
- Patients with a history of allergy to recombinant humanized antibody or human-mouse chimeric antibody or to any of the ingredients of BL-M09D1;
- Prior organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT);
- Anthracycline cumulative dose \> 360 mg/m2 in previous (new) adjuvant therapy;
- HIV antibody positive, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;
- Active infection requiring systemic therapy within 4 weeks before the first dose of study drug; Signs of pulmonary infection or active pulmonary inflammation within 2 weeks before the first dose;
- Pleural, abdominal, pelvic or pericardial effusion requiring drainage and/or with symptoms within 4 weeks before the first dose of study drug;
- Use of another clinical trial within 4 weeks or 5 half-lives before the first dose;
- Pregnant or lactating women;
- Other conditions for participation in the trial were not considered appropriate by the investigator.
Key Trial Info
Start Date :
May 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT06954077
Start Date
May 15 2025
End Date
December 1 2027
Last Update
May 31 2025
Active Locations (1)
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1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China