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New treatment option for Breast Cancer
Official title A Study of BL-M07D1 in Patients With Locally Advanced or Metastatic HER2 Positive/Low Expression Breast Cancer and Other Solid Tumors
ClinicalTrials.gov ID: NCT05461768
What this study is testing
What is BL-M07D1?
BL-M07D1 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
- In phase Ia study, the safety and tolerability of BL-B07D1 in patients with locally advanced or metastatic HER2-positive/low-expression breast cancer and other solid tumors will be investigated to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) of BL-M07D1. In phase Ib study, the safety and tolerability of BL-M07D1 at the phase Ia recommended dose will be further investigated, and recommended phase II dose (RP2D) for phase II clinical studies will be determined.
- Phase 1: an early, usually small safety study
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
- 1\. Sign the informed consent voluntarily and follow the program requirements
- 2\. No gender limitation;
- 3\. Age: ≥18 years old and ≤75 years old (Stage Ia);≥18 years old (Ib);
- 4\. Expected survival time ≥3 months;
- 5\. Inoperable locally advanced or metastatic HER2-positive/low-expression breast cancer and other solid tumors that have been histopathologically...
You likely can't join if
- 1\. Prior use of chemotherapy, biotherapy, immunotherapy, radical radiotherapy, major surgery (as defined by the investigator), targeted therapy...
- 2\. Prior ADC treatment (phase Ib only) with the toxin of camptothecin derivatives (topoisomerase I inhibitors);
- 3\. History of severe heart disease, such as symptomatic congestive heart failure (CHF) grade 2 or greater (CTCAE 5.0), NYHA grade 2 or greater heart...
- 4\. QT prolongation (male QTc \> 450 msec or female QTc \> 470 msec), complete left bundle branch block, III atrioventricular block;
- 5\. Active autoimmune diseases and inflammatory diseases, such as: systemic lupus erythematosus, systemic treatment of psoriasis, rheumatoid...
- 6\. Other malignancies diagnosed within 5 years prior to first administration, except for radical basal cell carcinoma of the skin, squamous cell...
See the full eligibility criteria
- 1\. Sign the informed consent voluntarily and follow the program requirements
- 2\. No gender limitation;
- 3\. Age: ≥18 years old and ≤75 years old (Stage Ia);≥18 years old (Ib);
- 4\. Expected survival time ≥3 months;
- 5\. Inoperable locally advanced or metastatic HER2-positive/low-expression breast cancer and other solid tumors that have been histopathologically and/or cytologically confirmed and have failed standard therapy, or are...
- 6\. Agree to provide archived tumor tissue samples or fresh tissue samples from the primary tumor or metastatic tumor within 2 years (to detect the expression of HER2 protein in tumor pathological tissue and explore the...
- 7\. Must have at least one measurable lesion as defined by RECIST V1.1;
- 8\. ECOG score of 0 or 1;
- 9\. Toxicity of previous antitumor therapy has returned to level ≤1 as defined by NCI-CTCAE V5.0 (the investigator considered asymptomatic laboratory abnormalities, such as elevated ALP, hyperuricemia, and elevated...
- 10\. No serious cardiac dysfunction, left ventricular ejection fraction ≥50%;
- 11\. Organ function level must meet the following requirements and meet the following standards: A) Bone marrow function: absolute neutrophil count (ANC) ≥1.5×10\^9/L, platelet count ≥90×10\^9/L, hemoglobin ≥90 g/L; B)...
- 12\. Coagulation function: International standardized ratio (INR) ≤1.5, and activated partial thrombin time (APTT) ≤1.5ULN;
- 13\. Urinary protein ≤2+ or ≤1000mg/24h;
- 14\. For premenopausal women at risk of fertility, pregnancy tests must be performed within 7 days prior to the start of treatment. Serum/urine pregnancy must be negative and must be non-lactation; All enrolled patients...
- 1\. Prior use of chemotherapy, biotherapy, immunotherapy, radical radiotherapy, major surgery (as defined by the investigator), targeted therapy (including small molecule tyrosine kinase inhibitors) and other antitumor...
- 2\. Prior ADC treatment (phase Ib only) with the toxin of camptothecin derivatives (topoisomerase I inhibitors);
- 3\. History of severe heart disease, such as symptomatic congestive heart failure (CHF) grade 2 or greater (CTCAE 5.0), NYHA grade 2 or greater heart failure, history of transmural myocardial infarction, unstable...
- 4\. QT prolongation (male QTc \> 450 msec or female QTc \> 470 msec), complete left bundle branch block, III atrioventricular block;
- 5\. Active autoimmune diseases and inflammatory diseases, such as: systemic lupus erythematosus, systemic treatment of psoriasis, rheumatoid arthritis, inflammatory bowel disease, and hashimoto's thyroiditis, etc., with...
- 6\. Other malignancies diagnosed within 5 years prior to first administration, except for radical basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or radical resected carcinoma in situ;
- 7\. Screening for unstable thrombotic events such as deep vein thrombosis, arterial thrombosis and pulmonary embolism requiring therapeutic intervention within the first 6 months; Infusion device-related thrombosis is...
- 8\. Patients with poorly controlled pleural effusion with clinical symptoms were judged by researchers to be unsuitable for inclusion;
- 9\. Hypertension poorly controlled by medications (systolic \& GT; 150 mmHg or diastolic pressure \& GT; 100 mmHg);
- 10\. According to CTCAE V5.0, patients were defined as ≥3 grade of lung disease, ≥2 grade of radioactive lung disease, existing or with a history of ILD;
- 11\. Symptoms of active CNS metastasis. But the researchers concluded that patients with stable parenchymal metastases could be included. The definition of stability must meet the following four requirements: A...
- 12\. Patients with a history of allergy to recombinant humanized antibody or human-mouse chimeric antibody or to any excipient component of BL-M07D1;
- 13\. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation (ALLO-HSCT);
- 14\. Equivalent cumulative dose of doxorubicin in anthracycline adjuvant therapy was \> 360 mg/m\^2;
- 15\. Positive human immunodeficiency virus antibody (HIVAb), active tuberculosis, active hepatitis B virus infection (HBV-DNA copy number \> lower limit) or active hepatitis C virus infection (HCV antibody positive and...
- 16\. Active infections requiring systemic treatment, such as severe pneumonia, bacteremia, sepsis, etc.
- 17\. Participated in another clinical trial within 4 weeks prior to initial administration (starting from the time of last administration);
- 18\. Pregnant or nursing women;
- 19\. Other conditions considered inappropriate for participation in this clinical trial by the investigator
The study team makes the final eligibility decision.
Where it's taking place
- Fuzhou, Fujian, China
- Dongguan, Guangdong, China
- Guangdong, Guangzhou, China
- Zhengzhou, Henan, China
- Wuhan, Hubei, China
- Jinan, Shandong, China
- Hangzhou, Zhejiang, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 Fuzhou, Fujian, China; Dongguan, Guangdong, China; Guangdong, Guangzhou, China; Zhengzhou, Henan, China; Wuhan, Hubei, China; Jinan, Shandong, China and 1 more location(s). 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.