A Phase II, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd) for the Treatment of Unresectable and/or Metastatic Solid Tumors Harboring HER2 Activating Mutations Regardless of Tumor Histology (DESTINY-PanTumor01)

Daiichi Sankyo Co., Ltd.0 个研究点目标入组 100 人开始时间: 2021年8月30日最近更新: 2024年5月17日

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方: Daiichi Sankyo Co., Ltd.
入组人数: 100
主要终点: Confirmed objective response rate by RECIST 1.1 based on independent central review (ICR)

暂无简介。

•Adults >=18 years old. Other age restrictions may apply as per local regulations.
•Unresectable and/or metastatic solid tumors with pre-specified HER2 mutations (S310F, S310Y, G660D, R678Q, D769Y, D769H, V777L, Y772_A775dup / A775_G776insYVMA, L755S, G778_P780dup / P780_Y781insGSP, T862A, and V842I locally determined by NGS or a validated nucleic acid-based methodology (eg, qPCR, digital PCR) ) on tumor tissue, who have progressed following prior treatment or who have no satisfactory alternative treatment options.
•Prior HER2 targeted therapy is permitted.
•All patients must provide an FFPE tumor sample for retrospective central HER2 testing.
•LVEF >=50%
•All patients have measurable target disease assessed by the Investigator based on RECIST v1.1

•HER2 overexpressing (IHC3+ or IHC2+/ISH+) breast, gastric or gastroesophageal junction adenocarcinoma.
•HER2 mutant NSCLC.
•Medical history of myocardial infarction within 6 months before randomization/enrolment, symptomatic CHF, unstable angina pectoris, clinically important cardiac arrhythmias, or a recent (< 6 months) cardiovascular event including stroke.
•History of non-infectious pneumonitis/ILD, current ILD, or where suspected ILD cannot be ruled out by imaging at screening.
•Corrected QT interval by Fridericia's formula (QTcF) prolongation to > 470 msec (females) or > 450 msec (males) based on average of the screening triplicate 12-lead ECG.
•Lung-specific intercurrent clinically significant severe illnesses.
•History of active primary immunodeficiency, known HIV, active HBV or HCV infection.
•Uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals.
•Pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (CART).
•Has spinal cord compression or clinically active central nervous system metastases.

Confirmed objective response rate by RECIST 1.1 based on independent central review (ICR)

时间窗: An average of approximately 12 months.

Confirmed ORR per RECIST 1.1 is the proportion of patients with Complete Response or Partial Response that is subsequently confirmed, based on ICR.

Duration of response (DoR) based on ICR and Investigator assessment(An average of approximately 12 months.)
Disease control rate (DCR) based on ICR and Investigator assessment(An average of approximately 12 months.)
Progression free survival (PFS) based on ICR and Investigator assessment(An average of approximately 12 months.)
Proportion of patients alive and progression-free(At 6 and 12 months.)
Confirmed Objective Response Rate (ORR) based on investigator assessment(An average of approximately 12 months.)
Overall survival (OS)(An average of approximately 20 months.)
Occurrence of adverse events (AEs) and serious adverse events (SAEs)(An average of approximately 14 months.)
Serum concentration of T-DXd(An average of approximately 14 months.)
Serum concentration of total anti-HER2 antibody(An average of approximately 14 months.)
Serum concentration of MAAA-1181a(An average of approximately 14 months.)
The immunogenicity of T-DXd assessed by the presence of ADAs for T-DXd(An avarage of approximately 14 months.)

发起方