A Phase II, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd, DS-8201a) for the Treatment of Selected HER2-expressing Tumors (DESTINY-PanTumor02)

Daiichi Sankyo Co., Ltd.0 个研究点目标入组 200 人开始时间: 2024年7月22日最近更新: 2024年11月12日

试验速览

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•Locally advanced, unresectable, or metastatic disease based on most recent imaging.
•The respective cohorts for patient inclusion are:
•Cohort A: Metastatic or advanced solid tumors that are HER2 IHC 3+ (excluding breast, gastric cancer, and colorectal cancer). Patients with non-small cell lung cancer can be included.
•Cohort B: Metastatic or advanced solid tumors that are HER2 IHC 2+/ISH+ any tumor type (excluding breast, gastric cancer, and colorectal cancer). Patients with non-small cell lung cancer can be included.
•Cohort C: Metastatic or advanced solid endometrial cancer that is HER2 IHC 2+ or 1+.
•Cohort D: Metastatic or advanced ovarian cancer that is HER2 IHC 2+ or 1+.
•Cohort E: Metastatic or advanced solid cervical cancer that is HER2 IHC 2+ or 1+.
•Progressed following prior treatment or who have no satisfactory alternative treatment option.
•Prior HER2 targeting therapy is permitted.
•HER2 expression scored using current ASCO/CAP guidelines for scoring HER2 for gastric cancer.
•IHC and ISH results by central assessment as pre-defined for each cohort
•Has measurable target disease assessed by the Investigator based on RECIST version 1.
•Has protocol- defined adequate organ function including cardiac, renal and hepatic function.

•History of non-infectious pneumonitis/ILD that required steroids, current ILD, or where suspected ILD that cannot be ruled out by imaging at screening
•Lung-specific intercurrent clinically significant severe illnesses
•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
•Known Somatic DNA mutation of HER2 (ERBB2) without tumoral HER2 protein expression.
•Patients with primary diagnosis of adenocarcinoma of the breast, adenocarcinoma of the colon or rectum, adenocarcinoma of the gastric body or gastro-esophageal junction will be excluded.
•Medical conditions that may interfere with the subject's participation in the study.

Objective Response Rate (ORR)

Confirmed ORR per RECIST 1.1 is the percentage of patients with Complete Response or Partial Response that is subsequently confirmed.

Duration of response (DoR)
Disease control rate (DCR)
Progression free survival (PFS)
Proportion of patients alive and progression-free at 6 months and 12 months(6 and 12 months)
Proportion of patients alive at 6 and 12 months(6 and 12 months)
Overall survival (OS)
Occurrence of adverse events (AEs) and serious adverse events (SAEs)
Pharmacokinetics (PK) assessed by serum concentration of T-DXd, total anti-HER2 antibody and MAAA-1181
The immunogenicity of T-DXd assessed by the presence of ADAs for T-DXd

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