Status:
RECRUITING
A Study of BL-M17D1 in Patients With Locally Advanced or Metastatic HER2 Positive/Negative Breast Cancer and Other Solid Tumors
Lead Sponsor:
Sichuan Baili Pharmaceutical Co., Ltd.
Collaborating Sponsors:
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Conditions:
Breast Cancer
Solid Tumor
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
- Sign the informed consent form voluntarily and follow the protocol requirements;
- Gender is not limited;
- Age: ≥18 years old and ≤75 years old (stage Ia); ≥18 years old (stage Ib);
- Expected survival time ≥3 months;
- Patients with locally advanced or metastatic HER2-positive/negative breast cancer and other solid tumors;
- Agree to provide archival tumor tissue samples or fresh tissue samples of primary or metastatic lesions within 3 years;
- Must have at least one extracranial measurable lesion that meets the RECIST v1.1 definition;
- ECOG 0 or 1;
- The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0;
- No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
- No blood transfusion is allowed within 14 days before the first use of the study drug, and no cell growth factor is allowed. The organ function level must meet the requirements;
- Coagulation function: international normalized ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5ULN;
- For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before the initiation of treatment, serum pregnancy must be negative, and the patient must not be lactating; All enrolled patients (male or female) were advised to use adequate barrier contraception throughout the treatment cycle and for 6 months after the end of treatment.
Exclusion
- Chemotherapy, biological therapy and other anti-tumor therapies have 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;
- Prolonged QT interval, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia;
- Active autoimmune and inflammatory diseases;
- Other malignancies diagnosed within 5 years before the first dose;
- Unstable thrombotic events requiring therapeutic intervention within 6 months before screening; Infusion-related thrombosis was excluded;
- Hypertension poorly controlled by two antihypertensive drugs (systolic blood pressure \> 150 mmHg or diastolic blood pressure \> 100 mmHg);
- A history of ILD requiring steroid therapy, or current ILD or radiation pneumonitis of grade ≥1 according to the RTOG/EORTC definition, or a suspicion of such disease;
- Patients with poor glycemic control;
- Complicated with pulmonary diseases leading to clinically severe respiratory function impairment;
- Patients with primary central nervous system tumors or CNS metastases after failure of local treatment;
- Patients with a history of allergy to recombinant humanized antibody or human-mouse chimeric antibody or to any of BL-M17D1's excipients;
- Prior organ transplantation or allogeneic hematopoietic stem cell transplantation;
- Prior anthracycline therapy with more than the protocol-specified cumulative dose of an anthracycline;
- Human immunodeficiency virus antibody positive, active tuberculosis, active hepatitis B virus infection or active hepatitis C virus infection;
- Active infection requiring systemic therapy with a serious infection within 4 weeks prior to informed consent; There were indications of pulmonary infection or active pulmonary inflammation within 2 weeks before informed consent;
- Patients with massive or symptomatic effusions, or poorly controlled effusions;
- Had 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 wounds, ulcers, or fractures 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 diarrhea;
- Who are scheduled to receive live vaccine or who receive the vaccine within 28 days before the first dose;
- The investigators did not consider it appropriate to apply other conditions for participation in the trial.
Key Trial Info
Start Date :
August 24 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06503783
Start Date
August 24 2024
End Date
August 1 2026
Last Update
November 12 2024
Active Locations (2)
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1
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
2
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China