ASP3082 for Cancer
Trial Summary
What is the purpose of this trial?
This trial is testing a new drug called ASP3082 for adults with advanced cancers. The drug works by blocking harmful proteins. The study will determine the best dose and check for any side effects.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, you must have completed any prior cancer treatments at least 21 days before starting the study, and any radiotherapy at least 14 days prior. It's best to discuss your specific medications with the study team.
What safety data exists for ASP3082 and related treatments?
The research does not provide specific safety data for ASP3082 or its related treatments like Cetuximab. However, it mentions that molecular target anticancer drugs, in general, have an increased risk of serious and fatal adverse events compared to placebo, indicating a need for careful monitoring.12345
Research Team
Medical Director
Principal Investigator
Astellas Pharma Inc
Eligibility Criteria
Adults with advanced solid tumors that can't be removed by surgery or have spread, and who have a specific mutation (KRAS G12D) after standard treatments or refusal of such therapies. They must be in good physical condition, not pregnant, agree to contraception use, and have recovered from previous treatment side effects.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation (Part 1)
Participants receive escalating doses of ASP3082, alone or with cetuximab, to determine suitable doses for Part 2
Dose Expansion (Part 2)
Participants receive ASP3082, alone or in combination with chemotherapy agents, at doses determined in Part 1
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- ASP3082
- Cetuximab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Astellas Pharma Inc
Lead Sponsor
Tadaaki Taniguchi
Astellas Pharma Inc
Chief Medical Officer since 2023
MD, PhD
Naoki Okamura
Astellas Pharma Inc
Chief Executive Officer since 2023
University of Tokyo, Faculty of Pharmacy