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Trial Title:
A Study of BL-M17D1 in Patients With Locally Advanced or Metastatic HER2 Positive/Negative Breast Cancer and Other Solid Tumors
NCT ID:
NCT06503783
Condition:
Breast Cancer
Solid Tumor
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
BL-M17D1
Description:
Administration by intravenous infusion for a cycle of 3 weeks.
Arm group label:
BL-M17D1
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 efficacy of BL-M17D1 in patients with
locally advanced or metastatic HER2 positive/negative breast cancer and other solid
tumors.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Sign the informed consent form voluntarily and follow the protocol requirements;
2. Gender is not limited;
3. Age: ≥18 years old and ≤75 years old (stage Ia); ≥18 years old (stage Ib);
4. Expected survival time ≥3 months;
5. Patients with locally advanced or metastatic HER2-positive/negative breast cancer
and other solid tumors;
6. Agree to provide archival tumor tissue samples or fresh tissue samples of primary or
metastatic lesions within 3 years;
7. Must have at least one extracranial measurable lesion that meets the RECIST v1.1
definition;
8. ECOG 0 or 1;
9. The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined
by NCI-CTCAE v5.0;
10. No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
11. 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;
12. Coagulation function: international normalized ratio (INR) ≤1.5, and activated
partial thromboplastin time (APTT) ≤1.5ULN;
13. 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 Criteria:
1. 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;
2. History of severe heart disease;
3. Prolonged QT interval, complete left bundle branch block, III degree
atrioventricular block, frequent and uncontrollable arrhythmia;
4. Active autoimmune and inflammatory diseases;
5. Other malignancies diagnosed within 5 years before the first dose;
6. Unstable thrombotic events requiring therapeutic intervention within 6 months before
screening; Infusion-related thrombosis was excluded;
7. Hypertension poorly controlled by two antihypertensive drugs (systolic blood
pressure > 150 mmHg or diastolic blood pressure > 100 mmHg);
8. 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;
9. Patients with poor glycemic control;
10. Complicated with pulmonary diseases leading to clinically severe respiratory
function impairment;
11. Patients with primary central nervous system tumors or CNS metastases after failure
of local treatment;
12. Patients with a history of allergy to recombinant humanized antibody or human-mouse
chimeric antibody or to any of BL-M17D1's excipients;
13. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation;
14. Prior anthracycline therapy with more than the protocol-specified cumulative dose of
an anthracycline;
15. Human immunodeficiency virus antibody positive, active tuberculosis, active
hepatitis B virus infection or active hepatitis C virus infection;
16. 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;
17. Patients with massive or symptomatic effusions, or poorly controlled effusions;
18. Had participated in another clinical trial within 4 weeks before the first dose;
19. Pregnant or lactating women;
20. Patients with superior vena cava syndrome should not be rehydrated;
21. A history of severe neurological or psychiatric illness;
22. Severe unhealed wounds, ulcers, or fractures within 4 weeks before signing the
informed consent;
23. Subjects with clinically significant bleeding or obvious bleeding tendency within 4
weeks before signing the informed consent;
24. History of intestinal obstruction, inflammatory bowel disease or extensive bowel
resection or presence of Crohn's disease, ulcerative colitis or chronic diarrhea;
25. Who are scheduled to receive live vaccine or who receive the vaccine within 28 days
before the first dose;
26. The investigators did not consider it appropriate to apply other conditions for
participation in the trial.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Harbin Medical University Cancer Hospital
Address:
City:
Ha'erbin
Country:
China
Status:
Recruiting
Contact:
Last name:
Qingyuan Zhang
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Jian Zhang
Start date:
August 24, 2024
Completion date:
August 2026
Lead sponsor:
Agency:
Sichuan Baili Pharmaceutical Co., Ltd.
Agency class:
Industry
Collaborator:
Agency:
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Sichuan Baili Pharmaceutical Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06503783
