a study of bl-m07d1 in patients with her2-expressing recurrent or metastatic gynecologic malignancies

Conditions: Gynecological Malignancies

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.


Eligibility criteria:
inclusion criteria: 1. sign the informed consent form voluntarily and follow the protocol requirements; 2. female; 3. age: ≥18 years old and ≤75 years old; 4. expected survival time ≥3 months; 5. 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; 6. the histopathology of gynecological malignant tumors should meet the following conditions: her2 positive; low expression of her2; 7. consent to provide archived tumor tissue samples or fresh tissue samples of primary or metastatic lesions within 2 years; 8. at least one measurable lesion meeting the recist v1.1 definition was required; 9. ecog score 0 or 1; 10. the toxicity of previous antineoplastic therapy has returned to ≤ grade 1 defined by nci-ctcae v5.0; 11. no severe cardiac dysfunction, left ventricular ejection fraction ≥50%; 12. 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; 13. urinary protein ≤2+ or ≤1000mg/24h; 14. albumin ≥30 g/l; 15. 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 cycle and for 6 months after the end of treatment. exclusion criteria: 1. 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; 2. had received prior adc drug therapy with camptothecin derivative (topoisomerase i inhibitor) as toxin; 3. had a history of serious cardiovascular and cerebrovascular diseases; 4. active autoimmune or inflammatory diseases; 5. 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; 6. unstable thrombotic events such as deep vein thrombosis, arterial thrombosis, and pulmonary embolism requiring medical intervention within 6 months before screening; 7. patients with massive or symptomatic effusions or poorly controlled effusions; 8. hypertension poorly controlled by antihypertensive drugs (systolic blood pressure \&gt; 150 mmhg or diastolic blood pressure \&gt; 100 mmhg); 9. current interstitial lung disease, drug-induced interstitial pneumonia, radiation pneumonitis requiring steroid therapy, or a history of these diseases; 10. patients with central nervous system (cns) metastases and/or carcinomatous meningitis (meningeal metastases); 11. patients with a history of allergy to recombinant humanized antibody or human-mouse chimeric antibody or to any ingredient of bl-m07d1; 12. patients received previous organ transplantation or allogeneic hematopoietic stem cell transplantation (allo-hsct); 13. hivab positive, active tuberculosis, active hepatitis b virus infection, or active hepatitis c virus infection; 14. active infections requiring systemic therapy, such as severe pneumonia, bacteremia, sepsis, etc.; 15. had participated in another clinical trial within 4 weeks before the first dose; 16. pregnant or lactating women; 17. the investigator did not consider it appropriate to apply other criteria for participation in the trial.

Keywords: her2 expression