Recruiting

T-DXd

Sponsor:

AstraZeneca

Code:

NCT07124000

Conditions

Adenocarcinoma (NOS)

Anal Cancer

Bladder Cancer

Cervical Cancer

Endometrial Cancer

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Trastuzumab deruxtecan

Study Details

Brief summary:

This study will evaluate the effectiveness of T-DXd in patients with HER2-positive (IHC 3+) locally advanced, unresectable, or metastatic solid tumors who have received prior systemic treatment for metastatic or advanced disease and have no satisfactory alternative treatment options in a real-world setting in the US

Conditions

Adenocarcinoma (NOS)

Anal Cancer

Bladder Cancer

Cervical Cancer

Endometrial Cancer

Study ID

NCT07124000

Start date

Sep 18, 2025

Status verified date

Aug, 2026

Completion date

Mar 30, 2028

Anticipated

Primary completion date

Mar 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Adults aged ≥18 years
2. Patients with locally advanced, unresectable, or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic treatment for metastatic or advanced disease and have no satisfactory alternative treatment options as determined by the Investigator (see Exclusion Criterion 1 for excluded solid tumors);
3. A clinician decision has been made for treatment with T-DXd in accordance with the FDA label;
4. HER2-positive (IHC 3+) by local testing prior to study enrolment at the time of signed and dated informed consent;
5. Patients who are willing and able to provide a signed and dated informed consent.

Exclusion Criteria:

1. Primary diagnosis of adenocarcinoma of the breast, adenocarcinoma of the colon or rectum, NSCLC, adenocarcinoma of the gastric body or gastroesophageal junction or hematological malignancies;
2. Prior T-DXd therapy;
3. Patients without a baseline assessment of tumor burden undertaken prior to initiating T-DXd.
4. Patient is participating in a clinical trial at time of enrolment

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Trastuzumab deruxtecan

Patients with locally advanced, unresectable, or metastatic HER-2 positive (IHC3+) solid tumours for whom a clinician decision has been made for treatment with T-DXd as part of routine clinical practice and in line with the FDA label

Interventions

Trastuzumab deruxtecan

Trastuzumab deruxtecan monotherapy

Primary outcome measure

  • Real world response rate (rwRR) [ Time Frame: Through study completion, up to 2.5 years after enrolment ]
  • Real world duration of response (rwDoR) [ Time Frame: Through study completion, up to 2.5 years after enrolment ]

Central Contacts and Locations

Central contacts

AstraZeneca Clinical Study Information Center

1-877-240-9479information.center@astrazeneca.com

Locations

Research Site

Recruiting

Birmingham, Alabama, United States, 35243

Research Site

Recruiting

Bullhead City, Arizona, United States, 86442

Research Site

Recruiting

Casa Grande, Arizona, United States, 85122

Research Site

Recruiting

San Diego, California, United States, 92123

Research Site

Recruiting

Boulder, Colorado, United States, 80309

Research Site

Recruiting

Coral Springs, Florida, United States, 33065

Research Site

Recruiting

St. Petersburg, Florida, United States, 33714

Research Site

Recruiting

West Palm Beach, Florida, United States, 33401

Research Site

Recruiting

Decatur, Illinois, United States, 62526

Research Site

Recruiting

Topeka, Kansas, United States, 66604

Research Site

Recruiting

Farmington, New Mexico, United States, 87401

Research Site

Recruiting

Durham, North Carolina, United States, 27708

Research Site

Recruiting

Wilson, North Carolina, United States, 27893

Research Site

Recruiting

Canton, Ohio, United States, 44718

Research Site

Recruiting

Maumee, Ohio, United States, 43537

Research Site

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Research Site

Recruiting

Nashville, Tennessee, United States, 37203

Research Site

Recruiting

Dallas, Texas, United States, 75390

More Information

Sponsor

AstraZeneca

Last update posted

Aug 25, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-08-25.