NCT05297552招募中2 期
An Open-label, Single-arm, Multi-center, Phase II Study to Evaluate the Efficacy and Safety of RC48-ADC Combined With JS001 in Perioperative Treatment of Muscle-Invasive Bladder Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Pathologic Complete Response (pCR) Rate
研究概览
简要总结
This study will evaluate the efficacy and safety of intravenous RC48-ADC combined with JS001 in perioperative treatment of muscle-invasive bladder cancer.
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
- •Voluntary agreement to provide written informed consent.
- •Male or female, Age ≥ 18 years.
- •Predicted survival ≥ 12 weeks.
- •Histologically confirmed diagnosis of muscle invasive bladder cancer (MIBC) .Naive of antitumor systematic treatment or radiotherapy.
- •Have clinically non-metastatic bladder cancer (cT2-T4a, N0-1, M0) determined by imaging.
- •Be deemed eligible for Radical Cystectomy (RC) + Pelvic Lymph Node Dissection (PLND).
- •HER2 expressing (i.e. IHC 1+ 2+ or 3+) as confirmed by the local lab.
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or
- •Adequate organ function, evidenced by the following laboratory results within 7 days prior to the study treatment.
- •Male and female participants are eligible to participate if they agree to the contraception use as per study protocol.
- •Willing to adhere to the study visit schedule and the prohibitions and restrictions specified in this protocol.
排除标准
- •Has received other antitumor therapy before planned start of trial treatment.
- •History of major surgery within 4 weeks of planned start of trial treatment.
- •Diagnosed with HBsAg, HBcAb positive and HBV DNA copy positive, or HCVAb positive, or HIVAb positive.
- •Has received a live virus vaccine within 4 weeks of planned start of trial treatment.
- •NYHA Class III heart failure.
- •Suffering from active infection requiring systemic treatment.
- •Uncontrolled hypertension, diabetes, Interstitial lung Disease, or COPD;
- •Treated with systemic treatment (e.g. immunomodulators, corticosteroids or immunosuppressants) for the autoimmune disease within 2 years prior to the study treatment.
- •History of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or cancers with a similar curative outcome as those mentioned above.
- •Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
- •Pregnancy or lactation.
- •Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.
研究组 & 干预措施
RC48-ADC + JS001
Experimental
Participants received 6 preoperative cycles of RC48-ADC PLUS JS001, followed by surgery, followed by up to 20 cycles of postoperative JS001.
干预措施: RC48-ADC (Drug)
RC48-ADC + JS001
Experimental
Participants received 6 preoperative cycles of RC48-ADC PLUS JS001, followed by surgery, followed by up to 20 cycles of postoperative JS001.
干预措施: JS001 (Drug)
结局指标
主要结局
Pathologic Complete Response (pCR) Rate
时间窗: Up to approximately 16 Weeks (Time of surgery)
pCR rate is defined as the percentage of participants having pCR. pCR is defined as absence of viable tumor (pT0pT0N0) in examined tissue from RC and PLND.
次要结局
- Rate of Pathologic Response(Up to approximately 16 Weeks (Time of surgery))
- Overall Survival (OS)(Up to approximately 60 Months.)
- 1-year Disease Free Survival Rate(From approximately 16 Weeks up to approximately 12 Months.)
- Objective Response Rate (ORR)(Up to approximately 12 Weeks.)
研究者
研究点 (2)
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相关资讯
Phase II Trial Shows Breakthrough 63.6% Response Rate for Novel Bladder Cancer Combination Therapy- Disitamab Vedotin combined with Toripalimab achieved a 63.6% pathological complete response rate in muscle-invasive bladder cancer patients, nearly doubling traditional chemotherapy outcomes.
- The clinical trial demonstrated strong efficacy across all HER2 expression levels, with HER2 IHC 3+ patients showing an exceptional 84.6% complete response rate.
- The treatment showed favorable safety with only 27.7% grade 3 or higher adverse events, significantly lower than conventional chemotherapy's 40-50% rate.last yearDisitamab Vedotin Plus Toripalimab Shows Promise in Muscle-Invasive Bladder Cancer- Phase 2 trial RC48-C017 shows promising efficacy and acceptable safety of neoadjuvant disitamab vedotin plus perioperative toripalimab in HER2-expressing muscle-invasive bladder cancer (MIBC).
- Pathological complete response (pCR) was observed in 63.6% of patients who underwent radical cystectomy, with a pathological response rate of 75.8%.
- The 12-month event-free survival (EFS) rate was 90.5%, and the 12-month overall survival (OS) rate was 95.5% in the intent-to-treat (ITT) population.
- Treatment-related adverse events were manageable, with no new safety signals identified, supporting the potential of this combination as a neoadjuvant treatment option.last yearDisitamab Vedotin Plus Toripalimab Shows Promise in HER2-Positive Muscle-Invasive Bladder Cancer• Neoadjuvant disitamab vedotin plus toripalimab demonstrates a 61.3% pathological complete response rate in patients with operable HER2-positive muscle-invasive bladder cancer (MIBC).
• The combination therapy showed an 85% event-free survival rate at 12 months, indicating a potential for improved clinical outcomes in this patient population.
• Treatment-related adverse events were generally mild, with the most common being alopecia, elevated liver enzymes, and rash, suggesting a manageable safety profile.
• The ongoing phase 2 study anticipates final completion in February 2025, with further data expected to refine the understanding of long-term efficacy and safety.2 years ago