BridgeMD
A study to investigate anti-tumor activity and safety of trastuzumab deruxtecan in patients with solid tumors carrying specific HER2 mutations.
EU CTIS ID: 2024-516158-22-00
What this study is testing
To assess the efficacy of T-DXd in patients with metastatic or unresectable tumors harboring specific HER2 activating mutations across tumor types.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adults ≥18 years old. Other age restrictions may apply as per local regulations.
- Unresectable and/or metastatic solid tumors with pre-specified HER2 mutations locally determined by NGS on tumor tissue, who have progressed following prior treatment or who have no satisfactory alternative treatment options.
- Prior HER2 targeted therapy is permitted.
- All patients must provide an FFPE tumor sample for retrospective central HER2 testing.
- LVEF ≥50%
- ECOG 0-1
You likely can't join if
- HER2 overexpressing (IHC3+ or IHC2+/ISH+) breast, gastric or gastroesophageal junction adenocarcinoma.
- HER2 mutant NSCLC.
- History of non-infectious pneumonitis/ILD, current ILD, or where suspected ILD cannot be ruled out by imaging at screening
- Lung-specific intercurrent clinically significant severe illnesses.
- History of active primary immunodeficiency, known HIV, active HBV or HCV infection
- Uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals
See the full eligibility criteria
- Adults ≥18 years old. Other age restrictions may apply as per local regulations.
- Unresectable and/or metastatic solid tumors with pre-specified HER2 mutations locally determined by NGS on tumor tissue, who have progressed following prior treatment or who have no satisfactory alternative treatment options.
- Prior HER2 targeted therapy is permitted.
- All patients must provide an FFPE tumor sample for retrospective central HER2 testing.
- LVEF ≥50%
- ECOG 0-1
- HER2 overexpressing (IHC3+ or IHC2+/ISH+) breast, gastric or gastroesophageal junction adenocarcinoma.
- HER2 mutant NSCLC.
- History of non-infectious pneumonitis/ILD, current ILD, or where suspected ILD cannot be ruled out by imaging at screening
- Lung-specific intercurrent clinically significant severe illnesses.
- History of active primary immunodeficiency, known HIV, active HBV or HCV infection
- 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).
- Has spinal cord compression or clinically active central nervous system metastases.
The study team makes the final eligibility decision.
Where it's taking place
- Japan
- United States
- Canada
- Korea, Republic of
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Japan; United States; Canada; Korea, Republic of. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.