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New treatment option for Breast Cancer
Official title A Study of BL-M17D1 in Patients With Locally Advanced or Metastatic HER2 Positive/Negative Breast Cancer and Other Solid Tumors
ClinicalTrials.gov ID: NCT06503783
What this study is testing
What is BL-M17D1?
BL-M17D1 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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;
You likely can't join if
- Chemotherapy, biological therapy and other anti-tumor therapies have been used within 4 weeks or 5 half-lives before the first dose; Mitomycin and...
- 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;
See the full eligibility criteria
- 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...
- 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...
- 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...
- 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;
- people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Harbin, Heilongjiang, China
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Harbin, Heilongjiang, China; Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.