DS-9606a for Cancer
Trial Summary
What is the purpose of this trial?
This trial tests DS-9606a, a new drug, in patients with advanced solid tumors to see if it is safe and effective. Researchers want to know if it can slow tumor growth and how the body handles the drug.
Will I have to stop taking my current medications?
The trial mentions an 'adequate treatment washout period' before starting the study treatment, which suggests you may need to stop certain medications. However, the specific medications or duration are not detailed, so it's best to discuss this with the trial team.
What data supports the effectiveness of the drug DS-9606a for cancer?
Research shows that targeting CLDN6, a protein found in many cancers but not in normal tissues, is promising for cancer treatment. Antibody-drug conjugates (ADCs) like DS-9606a, which target CLDN6, have been developed and show potential in treating cancers by delivering powerful drugs directly to cancer cells.12345
What safety data exists for DS-9606a or similar treatments targeting CLDN6 in cancer?
What makes the drug DS-9606a unique for cancer treatment?
DS-9606a is unique because it targets CLDN6, a specific protein found in some cancer cells, and uses a PBD (pyrrolobenzodiazepine) ADC (antibody-drug conjugate) to deliver a potent anti-cancer agent directly to these cells, potentially reducing harm to healthy cells compared to traditional chemotherapy.7891011
Research Team
Clinical Director
Principal Investigator
Daiichi Sankyo
Eligibility Criteria
Adults with advanced solid tumors, including ovarian and germ cell cancers, who are in good physical condition (ECOG score of 0 or 1) can join. They must have a life expectancy over 3 months, proper heart function, and agree to contraception. Those with brain metastases treated successfully may qualify; however, individuals with recent serious heart issues or uncontrolled infections cannot participate.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Participants receive an intravenous (IV) dose of DS-9606a starting at 0.016 mg/kg every 3 weeks to determine the maximum tolerated dose (MTD) and recommended dose for expansion (RDE)
Dose Expansion
Participants with ovarian cancer receive an intravenous (IV) dose of DS-9606a at the recommended dose for expansion (RDE) every 3 weeks to further explore safety and tolerability and assess the overall response rate
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- DS-9606a
Find a Clinic Near You
Who Is Running the Clinical Trial?
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
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