RecruitingPhase 1Phase 2NCT06131450

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

A Phase Ib/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M07D1 for Injection in Patients With HER2-expressing Recurrent or Metastatic Gynecologic Malignancies

Sponsor

Sichuan Baili Pharmaceutical Co., Ltd.

Enrollment

138 participants

Start Date

Feb 29, 2024

Study Type

INTERVENTIONAL

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

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Inclusion Criteria15

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 Criteria17

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.