NCT07099898招募中3 期
Phase 3, Multicenter, Randomized, Open-label Clinical Study of GSK5764227, a B7-H3 Antibody Drug Conjugate (ADC), Compared With Topotecan in Participants With Relapsed Small Cell Lung Cancer (SCLC)
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 420
- 试验地点
- 136
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
In this study researchers are testing Risvutatug rezetecan also known as (Ris-Rez) a new medicine that targets specific proteins (B7-H3) on cancer cells, thereby reducing the cancer's ability to grow and spread. This study specifically aims to evaluate how well Ris-Rez works in treating relapsed SCLC compared to standard treatment topotecan, by checking whether Ris-Rez makes cancers smaller or disappear completely and if it helps participants live longer. The study is also assessing whether Ris-Rez is safe and tolerated well by participants compared to topotecan and provide a better understanding of the main side effects of both drugs. Participants with relapsed SCLC will be randomly divided into two groups: one group receiving Ris-Rez and the other receiving topotecan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Participants are eligible to be included in the study only if all of the following criteria apply:
- •Adults >18 or the minimum legal adult age at the time the informed consent form is signed
- •Has histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC).
- •Has received 1 prior platinum-based systemic therapy with a PD- (L)1 inhibitor for at least 2 cycles of therapy and a chemotherapy free-interval of >30 days, with documented progression. Participants with prior tarlatamab treatment in either the first- or second-line ES-SCLC setting are eligible.
- •Has at least 1 target lesion per RECIST 1.1, as determined by the investigator.
- •Is capable of giving signed informed consent, including compliance with the requirements and restrictions listed in the ICF and in the protocol.
- •Has adequate organ function and an ECOG performance status of 0 or 1
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •Pathological diagnosis of complex SCLC or transformed SCLC.
- •Limited stage small cell lung cancer at diagnosis
- •Has received any prior therapy with an Antibody-drug conjugate (ADC) with a Topoisomerase-1 (TOPO1)-inhibitor payload or treatments targeting B7-H
- •Has known sensitivity to study intervention components or excipients or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study.
- •Has severe, uncontrolled or active cardiovascular disorders.
- •Has clinically significant bleeding symptoms or significant bleeding tendency within 1 month prior to the first dose.
- •Known active infectious diseases requiring systemic treatment or known Human immunodeficiency virus (HIV).
- •Has symptomatic brain metastases or untreated progression exclusively due to brain metastasis during or after the last treatment prior to screening, evidence of leptomeningeal/meningeal/brainstem metastasis or evidence of spinal cord metastases.
- •Has any evidence of current interstitial lung disease or pneumonitis or a prior history of ILD or non-infectious pneumonitis requiring high dose steroids.
- •Has significant pulmonary disease or respiratory impairment (e.g., uncontrolled asthma/COPD, restrictive lung disease),
- •Has active Hepatitis B or Hepatitis C
研究组 & 干预措施
Ris-Rez
Experimental
干预措施: Ris-Rez (Biological)
Topotecan
Active Comparator
干预措施: Topotecan (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: Up to approximately 113 weeks
OS is defined as the time from the date of randomization to the date of death by any cause
Objective Response Rate (ORR)
时间窗: Up to approximately 55 weeks
ORR is defined as the percentage of participants with a confirmed complete response (CR) or confirmed partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Blinded independent central review (BICR) assessment
Overall Survival (OS)
时间窗: Up to approximately 55 weeks
OS is defined as the time from the date of randomization to the date of death by any cause
次要结局
- Disease control rate (DCR) 12(Up to approximately 11 weeks)
- Brain DCR12(Up to approximately 11 weeks)
- Objective Response Rate (ORR)(Up to approximately 139 weeks)
- Duration of Response (DoR)(Up to approximately 139 weeks)
- Progression-free survival (PFS)(Up to approximately 139 weeks)
- Brain PFS(Up to approximately 139 weeks)
- Brain DoR(Up to approximately 139 weeks)
- Brain ORR(Up to approximately 139 weeks)
- Time to brain progression(Up to approximately 139 weeks)
- Number of participants with Adverse events (AEs), Serious Adverse Events (SAEs) and Adverse events of special interest (AESIs) by severity(Up to approximately 139 weeks)
- Number of participants with AEs leading to dose modifications or study intervention discontinuation(Up to approximately 139 weeks)
- Number of participants with a change from baseline in vital signs(Baseline (Day -1) and up to approximately 139 weeks)
- Number of participants with a change from baseline in laboratory parameters (hematology and clinical chemistry)(Baseline (Day -1) and up to approximately 139 weeks)
- Number of participants with a change from baseline in cardiac function [Electrocardiogram (ECG)(Baseline (Day -1) and up to approximately 139 weeks)
- Number of participants with a change from baseline in Eastern Cooperative Oncology Group (ECOG) performance status(Baseline (Day -1) and up to approximately 139 weeks)
- Observed PK concentrations of Ris-Rez (conjugated antibody and small molecule payload)(Up to approximately 139 weeks)
- Number of participants with Antidrug antibody (ADA) or Neutralizing Antibody (NAb)(Up to approximately 139 weeks)
- Titers of ADA against Ris-Rez(Up to approximately 139 weeks)
- Participant reported experience with study treatment(Up to approximately 139 weeks)
- Brain PFS(Up to approximately 161 weeks)
- Time to brain progression(Up to approximately 161 weeks)
- Number of participants with a change from baseline in cardiac function [Electrocardiogram (ECG)(Baseline (Day -1) and up to approximately 161 weeks)
- Number of participants with a change from baseline in Eastern Cooperative Oncology Group (ECOG) performance status(Baseline (Day -1) and up to approximately 161 weeks)
- Number of participants with Antidrug antibody (ADA) or Neutralizing Antibody (NAb)(Up to approximately 161 weeks)
- ORR by investigator assessment(Up to approximately 161 weeks)
- Duration of Response (DoR)(Up to approximately 161 weeks)
- Progression-free survival (PFS)(Up to approximately 161 weeks)
- Disease control rate (DCR) 12(Up to approximately 11 weeks)
- Brain DoR(Up to approximately 161 weeks)
- Brain ORR(Up to approximately 161 weeks)
- Number of participants with AEs leading to dose modifications or study intervention discontinuation(Up to approximately 161 weeks)
- Titers of ADA against GSK5764227(Up to approximately 161 weeks)
- Brain DCR12(Up to approximately 11 weeks)
- Number of participants with Adverse events (AEs), Serious Adverse Events (SAEs) and Adverse events of special interest (AESIs) by severity(Up to approximately 161 weeks)
- Number of participants with a change from baseline in vital signs(Baseline (Day -1) and up to approximately 161 weeks)
- Number of participants with a change from baseline in laboratory parameters (hematology and clinical chemistry)(Baseline (Day -1) and up to approximately 161 weeks)
- Observed PK concentrations of GSK5764227 (conjugated antibody and small molecule payload)(Up to approximately 161 weeks)
研究者
研究点 (136)
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相关资讯
Ris-Rez Cuts Death Risk 54% Versus Topotecan in Relapsed SCLC, First Phase III OS Win for a B7-H3 ADC- GSK and Hansoh reported that the B7-H3-targeted antibody-drug conjugate risvutatug rezetecan reduced the risk of death by 54% versus topotecan in relapsed small cell lung cancer.
- In the phase III ARTEMIS-008 trial, median overall survival reached 18.5 months with Ris-Rez versus 10.3 months with topotecan after a median 12.2 months of follow-up.
- Secondary endpoints favored Ris-Rez, with median progression-free survival of 7.2 versus 3.0 months and objective response rates of 58.3% versus 12.6%.
- Grade 3 or higher treatment-related adverse events occurred in 60.9% of Ris-Rez patients versus 78.2% with topotecan, with hematologic toxicities predominating.3 days agoFDA Grants Orphan Drug Designation to GSK's B7-H3-Targeted ADC for Small-Cell Lung Cancer- GSK's risvutatug rezetecan, a B7-H3-targeted antibody-drug conjugate, received FDA Orphan Drug Designation for small-cell lung cancer treatment based on durable responses in phase I trials.
- The designation addresses extensive stage SCLC, an aggressive cancer affecting 70% of SCLC patients with only 3% five-year survival rate and limited treatment options.
- This marks the fifth regulatory designation for risvutatug rezetecan, following similar recognition from the European Medicines Agency and previous FDA breakthrough therapy designations.
- GSK has initiated a global phase III trial for the drug in relapsed extensive stage SCLC, highlighting its potential in solid tumor treatment.9 months ago