Status:
RECRUITING
A Study of BL-M07D1 in Patients With HER2-expressing Recurrent or Metastatic Gynecologic Malignancies
Lead Sponsor:
Sichuan Baili Pharmaceutical Co., Ltd.
Collaborating Sponsors:
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Conditions:
Gynecological Malignancies
Eligibility:
FEMALE
18-75 years
Phase:
PHASE1
PHASE2
Brief 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 meta...
Eligibility Criteria
Inclusion
- 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 cycle and for 6 months after the end of treatment.
Exclusion
- 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.
Key Trial Info
Start Date :
February 29 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT06131450
Start Date
February 29 2024
End Date
December 1 2027
Last Update
September 26 2025
Active Locations (1)
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1
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China