HER3-DXd for Advanced Solid Tumors
This study is testing a new treatment called HER3-DXd for people with advanced solid tumors that have spread or cannot be removed by surgery. This includes various cancers like melanoma, head and neck cancer, and gastric cancer. The main goal is to see how well HER3-DXd works in shrinking tumors (objective response rate) or, for prostate cancer, how much it lowers PSA levels. Researchers will also look at the safety of HER3-DXd and how your body handles the drug. You may be able to join if you are 18 or older and have already received at least one other cancer treatment. The study is currently enrolling participants.
- Study design
- This is a proof-of-concept study investigating HER3-DXd monotherapy. It plans to enroll 740 participants.
- What's involved
- You will receive HER3-DXd as an intravenous infusion every three weeks. You will also need to sign consent forms and provide a tumor tissue sample.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your progress will be monitored from the start of the study until your disease gets worse, you pass away, are lost to follow-up, or withdraw, for up to approximately 27 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study of HER3-DXd in Subjects With Locally Advanced or Metastatic Solid Tumors
At a glance
Conditions
Where it's being run
86 sites across 27 statesStudy leadership
- Global Clinical Leader · STUDY_DIRECTOR · Daiichi Sankyo
Who to contact
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Do you actually qualify for this trial?
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Inclusion
What this trial measures
- Number of Participants With Objective Response Rate Assessed by Investigator Following HER3-DXd Monotherapy (All Cohorts Except Prostate Cancer Cohort)Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 27 months
Confirmed objective response rate (ORR) is defined as the sum of the complete response (CR) rate and partial response (PR) rate based on investigator by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.
- Proportion of Participants Achieving a ≥50% Decrease in PSA (Prostate Cancer Cohort Only)Baseline, each cycle before infusion (each cycle is 21 days), and end of treatment, up to approximately 27 months