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New treatment option for Gynecological Malignancies
Official title A Study of BL-M07D1 in Patients With HER2-expressing Recurrent or Metastatic Gynecologic Malignancies
ClinicalTrials.gov ID: NCT06131450
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 gynecological malignancies.
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 a single-arm, open, multicenter, non-randomized phase Ib/II clinical study evaluating the efficacy and safety of BL-M07D1 for injection in patients with HER2-expressing recurrent or metastatic gynecologic malignancies.
- Phase 2: a mid-size study of how well it works
- 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, women only
You may be able to join if
- Sign the informed consent form voluntarily and follow the protocol requirements;
- Female;
- Age: ≥18 years old and ≤75 years old;
- Expected survival time ≥3 months;
- patients with recurrent or metastatic HER2-positive/low-expression gynecologic malignancies who have failed or are intolerant to standard treatment...
You likely can't join if
- had received anti-tumor therapy before the first dose; Mitomycin and nitrosoureas; Oral fluorouracils; Palliative radiotherapy; Anti-tumor...
- had received prior ADC drug therapy with camptothecin derivative (topoisomerase I inhibitor) as toxin;
- had a history of serious cardiovascular and cerebrovascular diseases;
- active autoimmune or inflammatory diseases;
- Patients with other malignant tumors within 5 years before the first administration, except cured skin squamous cell carcinoma, basal cell carcinoma...
- Unstable thrombotic events such as deep vein thrombosis, arterial thrombosis, and pulmonary embolism requiring medical intervention within 6 months...
See the full eligibility criteria
- Sign the informed consent form voluntarily and follow the protocol requirements;
- Female;
- Age: ≥18 years old and ≤75 years old;
- Expected survival time ≥3 months;
- patients with recurrent or metastatic HER2-positive/low-expression gynecologic malignancies who have failed or are intolerant to standard treatment or who currently have no standard treatment;
- The histopathology of gynecological malignant tumors should meet the following conditions: HER2 positive; Low expression of HER2;
- Consent to provide archived tumor tissue samples or fresh tissue samples of primary or metastatic lesions within 2 years;
- At least one measurable lesion meeting the RECIST v1.1 definition was required;
- ECOG score 0 or 1;
- The 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%;
- No blood transfusion, use of any cell growth factors and/or platelet-raising drugs were allowed within 14 days before screening, and the organ function level had to be acceptable;
- Urinary protein ≤2+ or ≤1000mg/24h;
- albumin ≥30 g/L;
- Women who are likely to give birth must have negative serum/urine pregnancy within 7 days before treatment and must be non-lactating; All enrolled patients should have adequate contraception throughout the treatment...
- had received anti-tumor therapy before the first dose; Mitomycin and nitrosoureas; Oral fluorouracils; Palliative radiotherapy; Anti-tumor traditional Chinese medicine or Chinese patent medicine;
- had received prior ADC drug therapy with camptothecin derivative (topoisomerase I inhibitor) as toxin;
- had a history of serious cardiovascular and cerebrovascular diseases;
- active autoimmune or inflammatory diseases;
- Patients with other malignant tumors within 5 years before the first administration, except cured skin squamous cell carcinoma, basal cell carcinoma, superficial bladder cancer and prostate/cervix/breast cancer in situ;
- Unstable thrombotic events such as deep vein thrombosis, arterial thrombosis, and pulmonary embolism requiring medical intervention within 6 months before screening;
- patients with massive or symptomatic effusions or poorly controlled effusions;
- Hypertension poorly controlled by antihypertensive drugs (systolic blood pressure \> 150 mmHg or diastolic blood pressure \> 100 mmHg);
- Current interstitial lung disease, drug-induced interstitial pneumonia, radiation pneumonitis requiring steroid therapy, or a history of these diseases;
- patients with central nervous system (CNS) metastases and/or carcinomatous meningitis (meningeal metastases);
- patients with a history of allergy to recombinant humanized antibody or human-mouse chimeric antibody or to any ingredient of BL-M07D1;
- patients received previous organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT);
- HIVAb positive, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;
- active infections requiring systemic therapy, such as severe pneumonia, bacteremia, sepsis, etc.;
- had participated in another clinical trial within 4 weeks before the first dose;
- pregnant or lactating women;
- The investigator did not consider it appropriate to apply other criteria for participation in the trial.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing 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 female, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing 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.