NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2051240075

Registered date:26/06/2024

A Phase II Study of T-DXd in Patients with Selected HER2-expressing Tumors

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedHER2 Expressing Solid Tumors
Date of first enrollment22/07/2024
Target sample size200
Countries of recruitmentAustralia,Japan,Belgium,Japan,Canada,Japan,Czechia,Japan,India,Japan,Italy,Japan,Korea,Japan,Netherlands,Japan,Poland,Japan,Russia,Japan,Spain,Japan,Taiwan,Japan,Thailand,Japan,United Kingdom,Japan,United States,Japan
Study typeInterventional
Intervention(s)Drug: Trastuzumab deruxtecan 5.4 mg/kg via IV infusion on Day 1 of each cycle, every 3 weeks(q3w).

Outcome(s)

Primary Outcome- 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.
Secondary Outcome- Duration of response (DoR) DOR is defined as the time from the date of first documented response until the date of documented progression or death. - Disease control rate (DCR) DCR is the percentage of subjects who have a best overall response of complete response (CR) or partial response (PR) or stable disease (SD). - Progression free survival (PFS) PFS is the time from date of first dose of study treatment until the date of objective disease progression or death. - Proportion of patients alive and progression-free at 6 months and 12 months The proportion of patients alive and progression-free at 6 and 12 months (Kaplan-Meier estimates). - Overall survival (OS) OS is the time from date of first dose of study treatment until death due to any cause. - Proportion of patients alive at 6 and 12 months The proportion of patients alive at 6 and 12 months (Kaplan-Meier estimates). - Occurrence of adverse events (AEs) and serious adverse events (SAEs) Occurrence of AEs and SAEs graded according to NCI CTCAE v5.0. - Pharmacokinetics (PK) assessed by serum concentration of T-DXd, total anti-HER2 antibody and MAAA-1181 Individual patient data and descriptive statistics will be provided for serum concentration data at each time point for T-DXd, total anti-HER2 antibody and MAAA-1181a - The immunogenicity of T-DXd assessed by the presence of ADAs for T-DXd Individual participant data and descriptive statistics will be provided for data at each time point.

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximum<= 120age old
GenderBoth
Include criteria- 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 1.1. - Has protocol- defined adequate organ function including cardiac, renal and hepatic function.
Exclude criteria- 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.

Related Information

Contact

Public contact
Name Contact for Clinical Trial Information
Address 1-2-58, Hiromachi, Shinagawa-ku, Tokyo Tokyo Japan 140-8710
Telephone +81-3-6225-1111
E-mail dsclinicaltrial@daiichisankyo.co.jp
Affiliation Daiichi Sankyo Co., Ltd.
Scientific contact
Name Akihiro Inoguchi
Address 1-2-58, Hiromachi, Shinagawa-ku, Tokyo Tokyo Japan 140-8710
Telephone +81-3-6225-1111
E-mail dsclinicaltrial@daiichisankyo.co.jp
Affiliation Daiichi Sankyo Co., Ltd.