Becotatug Vedotin (MRG003) Combined With Epirubicin as Neoadjuvant Therapy for EGFR-Positive, Unresectable Recurrent Sinonasal Adenoid Cystic Carcinoma: A Prospective, Multicenter Clinical Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
This prospective, multicenter clinical study aims to evaluate the efficacy and safety of neoadjuvant therapy with MRG003 (Becotatug vedotin) combined with epirubicin in patients with EGFR-positive, unresectable recurrent sinonasal adenoid cystic carcinoma (SNACC). The primary question is whether this combination can achieve a sufficient objective response rate (ORR) to enable subsequent radical surgery or improve disease control.
详细描述
This is a prospective, multicenter, single-arm, open-label phase II clinical study. Patients with histologically confirmed recurrent sinonasal adenoid cystic carcinoma (SNACC) that is deemed unresectable by a multidisciplinary team (MDT) and positive for EGFR expression (IHC) are eligible.
Intervention:
- MRG003 (Becotatug vedotin): 2.0 mg/kg IV on day 1 of each 21-day cycle.
- Epirubicin: 75 mg/m² IV on day 1 of each 21-day cycle.
- Total of 3 neoadjuvant cycles.
Primary Outcome Measure: Objective response rate (ORR) according to RECIST v1.1, assessed 21 days (±7 days) after the third cycle.
Secondary Outcome Measures:
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years, male or female. Histopathologically confirmed sinonasal adenoid cystic carcinoma (SNACC) with measurable recurrent disease located in the sinonasal/skull base region, irrespective of the presence of regional lymph node or distant metastases.
- •EGFR expression positive by immunohistochemistry (IHC) performed at a central laboratory.
- •Multidisciplinary team (MDT) assessment at baseline confirms that the tumor is not amenable to radical (R0) surgical resection.
- •At least one measurable lesion in the skull base/sinonasal region according to RECIST v1.1 (longest diameter ≥ 10 mm).
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Adequate bone marrow, hepatic, renal, and cardiac function as defined by protocol-specified laboratory parameters.
- •Willing to provide written informed consent (including consent for clinical treatment and biospecimen research) and able to comply with study procedures.
排除标准
- •Prior treatment with any antibody-drug conjugate (ADC) that contains monomethyl auristatin E (MMAE) as the payload.
- •Prior systemic chemotherapy containing epirubicin or any other anthracycline within 6 months before study enrollment.
- •Active uncontrolled infection, or active autoimmune disease requiring systemic therapy.
- •Symptomatic or urgent (e.g., requiring radiotherapy or surgery) central nervous system (CNS) metastases.
- •Known severe hypersensitivity to any component of the study drugs. Pregnant or breastfeeding women, or men/women planning to become pregnant within 6 months after the last dose of study treatment.
- •Any medical or psychosocial condition that, in the investigator's judgment, may interfere with study participation, increase patient risk, or confound data interpretation.
研究组 & 干预措施
MRG003 + Epirubicin
Participants receive MRG003 (Becotatug vedotin) 2.0 mg/kg intravenously on day 1 plus epirubicin 75 mg/m² intravenously on day 1 of each 21-day cycle for 3 cycles.
干预措施: Becotatug Vedotin (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: 21 days (±7 days) after completion of the third cycle of neoadjuvant therapy (each cycle is 21 days).
Proportion of participants achieving complete response (CR) or partial response (PR) as assessed by the investigator according to RECIST v1.1 criteria.
次要结局
- Safety and tolerability(From first dose of study treatment up to 30 days after last dose (approximately 4 months per participant).)
- Surgical conversion rate(Within 4 weeks after completion of neoadjuvant therapy (i.e., approximately 3.5 months from treatment start).)
- Disease control rate (DCR)(21 days (±7 days) after completion of the third cycle of neoadjuvant therapy.)
- R0 resection rate(At time of surgery (within 4 weeks after neoadjuvant therapy completion).)
- Pathologic response rate(At time of surgery (within 4 weeks after neoadjuvant therapy completion).)
- Progression-free survival (PFS)(Assessed every 3 months for the first 2 years, then every 6 months up to 5 years, or until death or study completion (up to 48 months from first participant enrolled).)
- Overall survival (OS)(Assessed every 3 months for the first 2 years, then every 6 months up to 5 years, or until death or study completion (up to 48 months from first participant enrolled).)
研究者
Quan Liu
Chief Physician
Eye & ENT Hospital of Fudan University