NCT06131450招募中1 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Phase Ib: Recommended Phase II Dose (RP2D)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Sign the informed consent form voluntarily and follow the protocol requirements;
- •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.
排除标准
- •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.
研究组 & 干预措施
BL-M07D1
Experimental
Participants receive BL-M07D1 as intravenous infusion for the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.
干预措施: BL-M07D1 (Drug)
结局指标
主要结局
Phase Ib: Recommended Phase II Dose (RP2D)
时间窗: Up to approximately 24 months
The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for phase II study, based on safety, tolerability, efficacy, PK, and PD data collected during the dose escalation study of BL-M07D1.
Phase II: Objective Response Rate (ORR)
时间窗: Up to approximately 24 months
ORR is defined as the percentage of participants, who has a CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experiences a confirmed CR or PR is according to RECIST 1.1.
次要结局
- Treatment-Emergent Adverse Event (TEAE)(Up to approximately 24 months)
- Phase Ib: Objective Response Rate (ORR)(Up to approximately 24 months)
- Cmax(Up to approximately 24 months)
- Tmax(Up to approximately 24 months)
- Ctrough(Up to approximately 24 months)
- Disease Control Rate (DCR)(Up to approximately 24 months)
- Duration of Response (DOR)(Up to approximately 24 months)
- Progression-free Survival (PFS)(Up to approximately 24 months)
- ADA (anti-drug antibody)(Up to approximately 24 months)
研究者
研究点 (1)
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