Trastuzumab Deruxtecan for Cancer
(DPT02 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the effectiveness and safety of trastuzumab deruxtecan, an antibody-drug conjugate, for various cancers expressing the HER2 protein. It examines several cancer types, including bladder, biliary tract, cervical, endometrial, ovarian, pancreatic, and some rare tumors. People with advanced cancer showing HER2 protein might be suitable candidates, especially if other treatments have failed. The trial aims to determine if trastuzumab deruxtecan can improve outcomes compared to current options. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
Is there any evidence suggesting that this trial's treatment is likely to be safe?
Research has shown that trastuzumab deruxtecan is safe, as demonstrated in various studies. One study with 371 patients who had HER2-low breast cancer found the treatment to be generally well-tolerated. Most patients experienced side effects like nausea and tiredness, but these were usually manageable, while serious side effects were less common.
The FDA has already approved this treatment for other types of cancer, indicating it has undergone thorough testing and is safe for some patients. However, individual experiences may vary, so discussing expectations with a healthcare provider is important.12345Why are researchers excited about this trial's treatment?
Trastuzumab deruxtecan is unique because it combines an antibody with a chemotherapy drug, creating a powerful approach against cancer cells with high HER2 protein levels. Unlike traditional treatments that often target a wide range of cells, this drug specifically seeks out and binds to HER2-positive cancer cells, delivering its chemotherapy payload directly to the tumor. This targeted action not only intensifies the attack on cancer cells but also aims to reduce side effects by sparing healthy cells, making researchers hopeful for more effective and less toxic cancer treatment options.
What evidence suggests that trastuzumab deruxtecan could be an effective treatment for HER2-expressing tumors?
Research shows that trastuzumab deruxtecan (T-DXd) holds promise for treating various tumors expressing HER2. In this trial, participants will join different cohorts based on cancer type and HER2 expression levels. For tumors with high HER2 levels (IHC 3+), studies indicate that T-DXd significantly improves survival rates and reduces the risk of recurrence. In tumors with moderate HER2 levels (IHC 2+/ISH+), the treatment has demonstrated meaningful improvements in survival and disease progression. For endometrial and cervical cancers, real-world evidence suggests it works effectively, with notable patient responses. In biliary tract and pancreatic cancers, T-DXd has shown a 37.1% success rate in shrinking or eliminating tumors. Overall, T-DXd offers a potentially effective treatment option for these HER2-expressing tumors.13678
Are You a Good Fit for This Trial?
This trial is for people with certain HER2-expressing tumors, including ovarian, endometrial, biliary tract, and pancreatic cancers. Participants must have advanced or metastatic disease that has worsened after prior treatment or lack other treatment options. They should not have breast, colon, stomach cancer or non-small cell lung cancer and must be free of severe infections and conditions that could affect study participation.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive trastuzumab deruxtecan (T-DXd) for the treatment of selected HER2-expressing tumors across multiple cohorts
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants are monitored for overall survival and progression-free survival
What Are the Treatments Tested in This Trial?
Interventions
- Trastuzumab deruxtecan
Trastuzumab deruxtecan is already approved in United States, European Union, Japan for the following indications:
- Unresectable or metastatic HER2-positive breast cancer
- Locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma
- Unresectable or metastatic HER2-low breast cancer
- Unresectable or metastatic HER2-positive solid tumors
- Unresectable or metastatic HER2-positive breast cancer
- Locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma
- Unresectable or metastatic HER2-positive breast cancer
- Locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
AstraZeneca
Lead Sponsor
Sir Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Dr. Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Daiichi Sankyo Co., Ltd.
Industry Sponsor