DS-6000a for Kidney and Ovarian Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment, DS-6000a, for individuals with advanced kidney and ovarian cancer. The main goals are to determine a safe dose, identify side effects, and assess effectiveness. Participants will receive the treatment through an intravenous (IV) infusion. It suits those with advanced kidney or ovarian cancer who can provide a tumor sample. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive it.
Do I need to stop my current medications for the trial?
The trial requires an adequate treatment washout period (time without taking certain medications) before starting the study treatment, but it doesn't specify which medications need to be stopped. It's best to discuss your current medications with the trial team to understand what changes might be needed.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that DS-6000a, also known as raludotatug deruxtecan or R-DXd, has a safe profile in early studies. Initial results suggest that this treatment is well-tolerated for both kidney and ovarian cancer. In studies with patients who had tried other treatments, DS-6000a was tolerable.
Animal studies considered R-DXd safe. Ongoing trials in people with advanced kidney and ovarian cancers have reported manageable side effects. This suggests that R-DXd might be safe enough for further testing in humans. However, since DS-6000a remains in the early stages of research, more information is needed to fully understand its safety and effectiveness.12345Why do researchers think this study treatment might be promising for kidney and ovarian cancer?
Researchers are excited about DS-6000a because it offers a novel approach to treating kidney and ovarian cancers. Unlike standard treatments such as chemotherapy and targeted therapies that often have broad effects on both healthy and cancerous cells, DS-6000a is designed to deliver its cancer-fighting agent directly to tumor cells, potentially reducing side effects. This targeted mechanism of action means it could be more effective at attacking cancer cells while sparing healthy ones. Additionally, its delivery method as an intravenous infusion allows for precise dosing, which could further enhance its effectiveness and safety profile.
What evidence suggests that DS-6000a might be an effective treatment for kidney and ovarian cancer?
Research has shown that raludotatug deruxtecan (R-DXd, also known as DS-6000a) is showing early signs of effectiveness for both kidney and ovarian cancers. In studies, some patients with advanced kidney cancer (renal cell carcinoma) experienced partial responses, with their tumors shrinking. For ovarian cancer, R-DXd achieved a 50.5% response rate, meaning about half of the patients saw tumor reduction. In this trial, participants with either kidney or ovarian cancer will receive R-DXd in different treatment arms, including a dose escalation arm and dose expansion cohorts. The treatment targets specific tumors common in these cancers, enhancing the drug's ability to enter cancer cells. Early findings also indicate that the drug is generally well-tolerated, suggesting it could be a promising treatment.24678
Who Is on the Research Team?
Global Clinical Leader
Principal Investigator
Daiichi Sankyo
Are You a Good Fit for This Trial?
This trial is for adults with advanced kidney cancer or ovarian tumors who can consent, use effective contraception, have a good performance status (able to carry out daily activities), and proper heart function. They must not have had certain previous cancer treatments, multiple cancers unless cured over 3 years ago, recent serious heart issues, significant lung illnesses, uncontrolled infections or brain metastases.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Participants with ovarian cancer (OVC) or renal cell carcinoma (RCC) receive an intravenous infusion of R-DXd to assess safety and determine the maximum tolerated dose
Dose Expansion
Participants receive R-DXd at the recommended dose to evaluate clinical activity
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- DS-6000a
Find a Clinic Near You
Who Is Running the Clinical Trial?
Daiichi Sankyo
Lead Sponsor
Hiroyuki Okuzawa
Daiichi Sankyo
Chief Executive Officer
Degree in Social Sciences from Hitotsubashi University
Yuki Abe
Daiichi Sankyo
Chief Medical Officer since 2023
MD
Daiichi Sankyo, Inc.
Lead Sponsor
Yuki Abe
Daiichi Sankyo, Inc.
Chief Medical Officer since 2022
MD
Hiroyuki Okuzawa
Daiichi Sankyo, Inc.
Chief Executive Officer
Degree in Social Sciences from Hitotsubashi University
Merck Sharp & Dohme LLC
Industry Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University