Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Digestive System Diseases

Rare Diseases

Breast Neoplasms

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Antineoplastic Agents

All Drugs and Chemicals

Trastuzumab

Trastuzumab deruxtecan

Antineoplastic Agents, Immunological

Immunoconjugates

Immunologic Factors

Trastuzumab deruxtecan by intravenous infusion

AstraZeneca Clinical Study Information Center

This is an open-label, multicenter, Phase II study to evaluate the efficacy and safety of trastuzumab deruxtecan for the treatment in locally advanced, unresectable, or metastatic patients with selected HER2 overexpressingsolid tumors which are not eligible for curative therapy.

A Study of T-DXd in Patients With Selected HER2-overexpressing Tumors

A Phase II, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd, DS-8201a) for the Treatment of Patients With Selected HER2-overexpressing Tumors (DESTINY PanTumor03)

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

"Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.

Confirmed ORR by ICR is the proportion of patients who have a confirmed complete response or confirmed partial response, as determined by ICR per RECIST 1.1.

Confirmed ORR by investigator assessment is the proportion of patients who have a confirmed complete response or partial response, as determined by the investigator at local site per RECIST 1.1.

DoR by ICR is defined as the time from the date of first documented response until the date of documented progression (using RECIST 1.1 by ICR) or death in the absence of disease progression.

DoR by investigator assessment is defined as the time from the date of first documented response until the date of documented progression (using RECIST 1.1 by investigator assessment) or death in the absence of disease progression.

The DCR by ICR is defined as the percentage of patients who have a confirmed complete response (CR) or partial response (PR) or stable disease (SD) per RECIST 1.1 by ICR.

The DCR by investigator assessment is defined as the percentage of patients who have a confirmed complete response (CR) or partial response (PR) or stable disease (SD) per RECIST 1.1 by investigator assessment.

BOR by ICR is a patient's best response during their participation in the study up until RECIST 1.1-defined progression by ICR or the last evaluable assessment in the absence of RECIST 1.1-defined progression by ICR.

BOR by investigator assessment is a patient's best response during their participation in the study up until RECIST 1.1 defined progression or the last evaluable assessment in the absence of RECIST 1.1 defined progression.

PFS by ICR will be defined as the time from the date of enrollment until the date of objective progressive disease (PD) per RECIST 1.1 as assessed by ICR or death.

PFS by investigator assessment is defined as the time from the date of enrollment until the date of progressive disease (PD) per RECIST 1.1 as assessed by the investigator or death.

OS is defined as the time from the date of enrollment until death due to any cause.

The grading scales found in the revised NCI CTCAE v5.0 will be utilized for all events.

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.

Incidence of anti-drug antibodies against T-DXd in serum at each time point.

Spots Global Cancer Trial Database for advanced solid tumors (excluding gastric cancer and breast cancer)