2023-508057-19-00尚未招募3 期
DESTINY-Biliary Tract Cancer-01: A Phase 3 Study of Trastuzumab Deruxtecan (T-DXd) and Rilvegostomig versus Standard-of-Care Gemcitabine, Cisplatin, and Durvalumab for First Line Locally Advanced or Metastatic HER2-expressing Biliary Tract Cancer.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 133
- 试验地点
- 65
- 主要终点
- To evaluate the efficacy of T-DXd with rilvegostomig vs Standard of Care in terms of Overall Survival in the FAS (HER2 IHC 3+) population
研究概览
简要总结
The primary objective of this study is to assess the efficacy of T-DXd with rilvegostomig vs Standard of Care (SoC) in terms of OS in the FAS (HER2 IHC 3+) population.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Participants (male and female) must be ≥ 18 years of age at the time of screening. Other age restrictions may apply as per local regulations.
- •Unresectable, previously untreated, locally advanced or metastatic BTC. Prior treatment in the perioperative and/or adjuvant setting is permissible provided there is > 6 months (180 days) between the end of adjuvant treatment and the diagnosis of locally advanced or metastatic disease.
- •Histologically confirmed HER2-expressing (IHC 3+ or IHC 2+) BTC.
- •Provision of FFPE tumor sample that is no older than 3 years.
- •At least one target lesion assessed by the Investigator based on RECIST v1.1 (randomized portion only).
- •WHO/ECOG performance status of 0 or 1
- •Adequate organ and bone marrow function within 14 days before randomization.
- •Evidence of post-menopausal status or negative serum pregnancy test for females of childbearing potential.
排除标准
- •Prior exposure to other HER2 targeting therapies, ADCs, immune checkpoint inhibitors and therapeutic anticancer vaccines.
- •Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder
- •Prior pneumonectomy (complete)
- •Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals
- •Active primary immunodeficiency, known uncontrolled active HIV infection or HCV
- •Pregnant or breastfeeding female patients, or patients who are planning to become pregnant
- •Participation in another clinical study with a study intervention or investigational medicinal device administered in the last 6 months prior to randomization, or concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study (only randomized portion)
- •Histologically confirmed ampullary carcinoma
- •History of substance abuse or any other medical conditions such as clinically significant cardiac or psychological conditions
- •Spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms
- •Medical history of myocardial infarction within 6 months before randomization/enrollment, symptomatic congestive heart failure (New York Heart Association Class II to IV), unstable angina pectoris, clinically important cardiac arrhythmias, or a recent (< 6 months) cardiovascular event including stroke
- •Serious chronic gastrointestinal conditions associated with diarrhea (eg, active inflammatory bowel disease); active non-infectious skin disease (including any grade rash, urticaria, dermatitis, ulceration, or psoriasis) requiring systemic treatment
- •Active autoimmune, connective tissue or inflammatory disorders that has required systemic treatment in the past 2 years, or where there is documented, or a suspicion of pulmonary involvement at the time of screening
- •Corrected QT interval (QTcF) prolongation to > 470 msec (females) or > 450 msec (males) based on average of the screening triplicate 12-lead ECG
- •History of (non-infectious) ILD/pneumonitis, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening
结局指标
主要结局
To evaluate the efficacy of T-DXd with rilvegostomig vs Standard of Care in terms of Overall Survival in the FAS (HER2 IHC 3+) population
To evaluate the efficacy of T-DXd with rilvegostomig vs Standard of Care in terms of Overall Survival in the FAS (HER2 IHC 3+) population
次要结局
- To evaluate the efficacy of T-DXd with rilvegostomig vs SoC in terms of OS in the FAS population (HER2 IHC 3+/2+).
- To evaluate the efficacy of T-DXd monotherapy vs SoC in terms of OS in the FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations.
- To further evaluate efficacy of T‑DXd with rilvegostomig or in monotherapy vs SoC in terms of PFS in the FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations.
- To further evaluate the efficacy of T-DXd with rilvegostomig or in monotherapy vs SoC in terms of ORR in the FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations.
- To further evaluate efficacy of T‑DXd with rilvegostomig or in monotherapy vs SoC in terms of DoR in patients with HER2‑expressing BTC in the FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations.
- To further evaluate the efficacy of T-DXd with rilvegostomig versus T-DXd monotherapy in terms of OS, PFS, DoR and ORR in FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations.
- To assess the safety and tolerability of T‑DXd with rilvegostomig or in monotherapy vs SoC.
- To assess the safety and tolerability of TDXd with rilvegostomig vs T-DXd monotherapy.
- To describe patient-reported tolerability of TDXd with rilvegostomig or in monotherapy in comparison to SoC based on a summary of symptomatic AEs and overall side-effect bother.
- To describe patient-reported tolerability of TDXd with rilvegostomig in comparison to T-DXd monotherapy based on a summary of symptomatic AEs and overall side-effect bother.
- To assess time to deterioration in physical functioning in patients treated with T-DXd with rilvegostomig or in monotherapy vs SoC.
- To assess time to deterioration in physical functioning in patients treated with T-DXd with rilvegostomig vs T-DXd monotherapy.
- To assess the PK of T-DXd, total anti-HER2 antibody, DXd and rilvegostomig in serum.
- To investigate the immunogenicity of T-DXd and of rilvegostomig.
研究者
AstraZeneca Clinical Study Information Center
Scientific
AstraZeneca AB
研究点 (65)
Loading locations...
相似试验
招募中
3 期
A trial to learn if Dato-DXd with rilvegostomig, or rilvegostomig alone, is safe and works compared with pembrolizumab in people who have advanced non-squamous non-small cell lung cancer (NSCLC) with high levels of the PD-L1 protein2023-505077-32-00AstraZeneca AB199
招募中
3 期
Phase 3 Study of T-DXd and Rilvegostomig Versus SoC in Advanced HER2-expressing Biliary Tract CancerBiliary Tract CancerNCT06467357AstraZeneca620
进行中（未招募）
不适用
VALEMETOSTAT 与 DXd ADC 联合治疗的研究CTR2025073238
尚未招募
3 期
A trial comparing the treatment of rilvegostomig with fluoropyrimidine and trastuzumab deruxtecan to the standard treatment in patients with HER2-positive gastric cancer.2024-512583-57-00AstraZeneca AB204
进行中（未招募）
1/2 期
GV20-0251 注射液在晚期实体瘤患者中开展的 I/II 期临床试验CTR20252531350