Home › Trials › NCT07124000

Testing trastuzumab deruxtecan (T‑DxD) for HER2‑positive advanced solid tumors

Effectiveness of T-DXd Across HER2-positive Solid Tumors in Patients Who Have Received Prior Systemic Treatment and Have no Satisfactory Alternative Treatment Options: A Hybrid Observational Study

Observational AstraZeneca · NCT07124000

This will test whether trastuzumab deruxtecan (T‑DxD) helps adults in the US with HER2‑positive (IHC 3+) locally advanced, unresectable, or metastatic solid tumors who have had prior systemic treatment and have no satisfactory alternative options.

Quick facts

Study typeObservational
Enrollment100 (estimated)
Ages18 Years to 130 Years
SexAll
SponsorAstraZeneca Industry-sponsored
Drugs / interventionstrastuzumab
Locations17 sites (Birmingham, Alabama and 16 other locations)
Trial IDNCT07124000 on ClinicalTrials.gov

What this trial studies

This is a multicenter, hybrid observational study enrolling about 100 patients in the US who start trastuzumab deruxtecan (T‑DxD) in routine clinical practice per FDA label. Patients must have HER2‑positive (IHC 3+) locally advanced, unresectable, or metastatic solid tumors, have received prior systemic therapy for advanced disease, and not have satisfactory alternative treatments; common tumor types such as breast, colorectal, NSCLC, gastric/GEJ, and hematologic malignancies are excluded. Approximately 30 sites, emphasizing community oncology settings alongside hospital systems and academic centers, will prospectively capture real‑world treatment, tumor response, and timing outcomes. The primary endpoints are real‑world response rate and duration of response, with secondary endpoints including time to treatment discontinuation and time to next treatment.

Who should consider this trial

Good fit: Adults (≥18) with HER2‑positive (IHC 3+) locally advanced, unresectable, or metastatic solid tumors who have received prior systemic therapy, have no satisfactory alternative options, and are starting T‑DxD per FDA label are ideal candidates.

Not a fit: Patients with primary breast, colorectal, non‑small cell lung, gastric/GEJ cancers, hematologic malignancies, those with prior T‑DxD therapy, or those lacking a baseline tumor assessment are excluded and unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, the study could provide real‑world evidence about how well T‑DxD works across diverse non‑excluded HER2‑positive solid tumors, helping clinicians make treatment decisions.

How similar studies have performed: Trastuzumab deruxtecan has shown clear benefit in HER2‑positive breast cancer and activity in some other tumor types, but robust real‑world evidence across a broad set of non‑breast HER2‑positive solid tumors remains limited.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Birmingham, Alabama and 16 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions AdenocarcinomaAnal CancerBladder CancerCervical CancerEndometrial CancerEsophageal CancerGall Bladder CancerGastrointestinal Stromal Tumour
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.