New drug targets Hard-to-Treat gynecologic cancers in early trial

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 \> 150 mmHg or diastolic blood pressure \> 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.