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Clinical Trials List

Protocol NumberD967VC00001
NCT Number(ClinicalTrials.gov Identfier)NCT04482309
Active

2020-08-01 - 2028-06-30

Phase II

Recruiting6

ICD-10Z12.6

Encounter for screening for malignant neoplasm of bladder

ICD-9V76.3

Special screening for malignant neoplasms, bladder

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)

  • Trial Applicant

  • Sponsor

    AstraZeneca

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Yi-Ping Hung Division of Hematology & Oncology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chia-Chi Lin Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 蕭聖諺 Division of Hematology & Oncology
Chi Mei Hospital, Liouying

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chien-Hsing Lu Division of Obstetrics & Gynecology
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Jen-Shi Chen Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 張志隆 Division of Obstetrics & Gynecology
MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Trastuzumab deruxtecan will show meaningful clinical activity and a favorable risk benefit profile in selected HER2-expressing solid tumors.

Objectives

Primary Outcome Measures : Objective Response Rate (ORR) [ Time Frame: An average of approximately 12 months ] Confirmed ORR per RECIST 1.1 is the percentage of patients with Complete Response or Partial Response that is subsequently confirmed. Secondary Outcome Measures : Duration of response (DoR) [ Time Frame: An average of approximately 18 months ] 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) [ Time Frame: An average of approximately 18 months ] 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) [ Time Frame: An average of approximately 18 months ] 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 [ Time Frame: Up to 12 months ] The proportion of patients alive and progression-free at 6 and 12 months (Kaplan-Meier estimates). Overall survival (OS) [ Time Frame: An average of approximately 30 months ] 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 [ Time Frame: Up to 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) [ Time Frame: An average of approximately 24 months ] 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 [ Time Frame: An average of approximately 24 months ] 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 [ Time Frame: An average of approximately 24 months ] Individual participant data and descriptive statistics will be provided for data at each time point.

Test Drug

Trastuzumab deruxtecan (ENHERTUR)

Active Ingredient

Trastuzumab deruxtecan (T-DXd, DS-8201a)

Dosage Form

Frozen crystal injection

Dosage

20 mg/mL

Endpoints

Objective Response Rate (ORR) [ Time Frame: An average of approximately 12 months ]
Confirmed ORR per RECIST 1.1 is the percentage of patients with Complete Response or Partial Response that is subsequently confirmed.

Inclution Criteria

Inclusion Criteria:

Locally advanced, unresectable, or metastatic disease based on most recent imaging.
The respective cohorts for patient inclusion are:

Cohort 1: Biliary tract cancer
Cohort 2: Bladder cancer
Cohort 3: Cervical cancer
Cohort 4: Endometrial cancer
Cohort 5: Epithelial ovarian cancer
Cohort 6: Pancreatic cancer
Cohort 7: Rare tumors: This cohort will consist of patients with tumors that express HER2, excluding the tumors mentioned above, and breast, non-small cell lung cancer, gastric cancer, and colorectal cancer.
Progressed following prior treatment or who have no satisfactory alternative treatment option.
Prior HER2 targeting therapy is permitted.
HER2 expression for eligibility may be based on local or central assessment.
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.

Exclusion Criteria

Exclusion 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.
Primary diagnosis of adenocarcinoma of the breast, adenocarcinoma of the colon or rectum, adenocarcinoma of the gastric body or gastro-esophageal junction, or non-small cell lung cancer.
Medical conditions that may interfere with the subject's participation in the study.

The Estimated Number of Participants

  • Taiwan

    40 participants

  • Global

    480 participants

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