A Study of BL-M07D1 in Patients With HER2-expressing Recurrent or Metastatic Gynecologic Malignan… (NCT06131450) | Clinical Trial Compass
RecruitingPhase 1/2
A Study of BL-M07D1 in Patients With HER2-expressing Recurrent or Metastatic Gynecologic Malignancies
China138 participantsStarted 2024-02-29
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexFEMALE
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Inclusion 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;
Exclusion criteria
✕. 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;
✕. 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);