A Study of BL-M07D1 in Patients With HER2-expressing Recurrent or Metastatic Gynecologic Malignancies

Launched by SICHUAN BAILI PHARMACEUTICAL CO., LTD. · Nov 9, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called BL-M07D1 for women with specific types of gynecologic cancers that express a protein called HER2. These cancers are either recurring or have spread to other parts of the body, and the trial is looking to see if this treatment is safe and effective for patients who have not responded to standard therapies or who do not have any standard treatment options available. The trial is currently recruiting female participants aged 18 to 75 who have been diagnosed with HER2-positive or low-expression gynecologic cancers and have measurable tumors.

Eligible participants can expect to receive the BL-M07D1 injection and will be monitored for any side effects and how well the treatment works. It’s important to note that participants must not have serious heart conditions or active infections and should have a good overall health status. Additionally, women who could become pregnant must use contraception during the trial. This study aims to offer hope for patients facing limited options in their cancer treatment journey.

Gender

FEMALE

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 \> 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.