a study of bl-m09d1 in patients with locally advanced or metastatic gastrointestinal tumors and other solid tumors

Conditions: Gastrointestinal Tumor; Solid Tumor

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 efficacy of bl-m09d1 for injection in patients with locally advanced or metastatic gastrointestinal tumors and other solid tumors.


Eligibility criteria:
inclusion criteria: 1. voluntarily sign the informed consent and follow the requirements of the protocol; 2. no gender limit; 3. age: ≥18 years old and ≤75 years old (phase ia); ≥18 years old (phase ib); 4. expected survival time ≥3 months; 5. pathologically and/or cytologically confirmed locally advanced or metastatic gastrointestinal tumors and other solid tumors that failed standard treatment; 6. consent to provide archival tumor tissue samples or fresh tissue samples from primary or metastatic lesions within 2 years; 7. must have at least one measurable lesion according to recist v1.1 definition; 8. ecog 0 or 1; 9. toxicity of previous antineoplastic therapy has returned to ≤ grade 1 defined by nci-ctcae v5.0; 10. no severe cardiac dysfunction, left ventricular ejection fraction ≥50%; 11. organ function level must meet the requirements; 12. coagulation function: international normalized ratio (inr) ≤1.5, and activated partial thromboplastin time (aptt) ≤1.5uln; 13. urine protein ≤2+ or ≤1000mg/24h; 14. 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; 15. participants were able and willing to comply with protocol-specified visits, treatment plans, laboratory tests, and other study-related procedures. exclusion criteria: 1. 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; 2. history of severe heart disease; 3. qt prolongation, complete left bundle branch block, iii degree atrioventricular block; 4. active autoimmune and inflammatory diseases; 5. other malignant tumors diagnosed within 5 years before the first dose; 6. unstable thrombotic events requiring therapeutic intervention within 6 months before the first dose; 7. poorly controlled hypertension; 8. patients with poor glycemic control; 9. history of ild requiring steroid therapy, or current ild or ≥ grade 2 radiation pneumonitis; 10. complicated pulmonary diseases leading to clinically severe respiratory function impairment; 11. symptoms of active central nervous system metastasis; 12. patients with a history of allergy to recombinant humanized antibody or human-mouse chimeric antibody or to any of the ingredients of bl-m09d1; 13. prior organ transplantation or allogeneic hematopoietic stem cell transplantation (allo-hsct); 14. anthracycline cumulative dose \> 360 mg/m2 in previous (new) adjuvant therapy; 15. hiv antibody positive, active tuberculosis, active hepatitis b virus infection, or active hepatitis c virus infection; 16. 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; 17. pleural, abdominal, pelvic or pericardial effusion requiring drainage and/or with symptoms within 4 weeks before the first dose of study drug; 18. use of another clinical trial within 4 weeks or 5 half-lives before the first dose; 19. pregnant or lactating women; 20. other conditions for participation in the trial were not considered appropriate by the investigator.