Status:
RECRUITING
A Study of BL-M17D1 in Patients With Locally Advanced or Metastatic HER2 Positive/Lower Expression Gastrointestinal Cancer and Other Solid Tumors
Lead Sponsor:
Sichuan Baili Pharmaceutical Co., Ltd.
Collaborating Sponsors:
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Conditions:
Esophageal Cancer
Gastric Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
This study is an open, multicenter, dose-escalation and expansion-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 (stage Ia); ≥18 years old (stage Ib);
- Expected survival time ≥3 months;
- The pathologic histology and/or cytology diagnosis of locally advanced or metastatic positive HER2 / low expression of the digestive tract tumor and other solid tumor;
- 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 ≤1.5, and activated partial thromboplastin time ≤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 the patients (no matter male or female) shall be 6 months after the end of the treatment period and full barrier precautions.
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, frequent and uncontrollable arrhythmia;
- Active autoimmune and inflammatory diseases;
- Other malignant tumors diagnosed within 5 years before the first dose;
- Hypertension poorly controlled by two antihypertensive drugs;
- Patients with poor glycemic control before the first dose;
- Have to hormone treatment of interstitial lung disease, or the current with ILD or suspected suffering from such diseases;
- Complicated pulmonary diseases leading to clinically severe respiratory function impairment;
- Patients with massive or symptomatic effusions or poorly controlled effusions;
- Imaging examination showed that the tumor had invaded or wrapped around the chest, neck, pharynx and other large blood vessels;
- Screening for unstable thrombotic events requiring therapeutic intervention within the preceding 6 months;
- Patients with active central nervous system metastases;
- Patients with a history of allergy to recombinant humanized antibody or human-mouse chimeric antibody or to any of the excipients of BL-M17D1;
- Prior organ transplantation or allogeneic hematopoietic stem cell transplantation;
- HIV antibody positive, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;
- Active infection requiring systemic therapy with serious infection within 4 weeks before informed consent; There were indications of pulmonary infection or active pulmonary inflammation within 2 weeks before informed consent;
- Participated in another clinical trial within 4 weeks before the first dose;
- Pregnant or lactating women;
- Patients with superior vena cava syndrome should not be rehydrated;
- A history of severe neurological or psychiatric illness;
- Severe unhealed wound, ulcer, or fracture within 4 weeks before signing the informed consent;
- Subjects with clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing the informed consent;
- History of intestinal obstruction, inflammatory bowel disease, or extensive bowel resection or presence of Crohn's disease, ulcerative colitis, or chronic disease Sexual diarrhea;
- Patients scheduled for vaccination or receiving live vaccine within 28 days before the first dose;
- Other conditions for participation in the trial were not considered appropriate by the investigator.
Key Trial Info
Start Date :
July 24 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06500052
Start Date
July 24 2024
End Date
August 1 2026
Last Update
September 18 2025
Active Locations (1)
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1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China