A Study of ASP3082 in Adults With Advanced Solid Tumors
A Phase 1 Study of ASP3082 in Participants With Locally Advanced or Metastatic Solid Tumor Malignancies With KRAS G12D Mutation
Sponsor: Astellas Pharma Inc
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Incidence of Dose Limiting Toxicities (DLTs)
Time frame: Up to 28 Days
Number of Participants with Adverse Events (AEs)
Time frame: Up to 48 months
Number of Participants with Serious Adverse Events (SAEs)
Time frame: Up to 48 months
Number of Participants with laboratory value abnormalities and/or adverse events (AEs)
Time frame: Up to 48 months
Secondary Endpoints
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Duration of Response (DOR) per RECIST v 1.1
Disease Control Rate (DCR) per RECIST v 1.1
Eligibility Criteria
Inclusion Criteria: * Participant has locally advanced (unresectable) or metastatic solid tumor malignancy with documented Kirsten rat sarcoma viral oncogene homolog \[KRAS\] G12D mutation and has received prior standard therapy and the investigator does not see any further clinical benefit from continuing such targeted therapy, or is ineligible to receive standard approved therapies (no limit to the number of prior treatment regimens). * For the ASP3082 monotherapy escalation cohorts, participants with solid tumor malignancies are allowed to be enrolled. Participants with other known KRAS G12 mutations will not be eligible for the study * For ASP3082 combination therapy with Nab-P+GEM or FOLFIRINOX or NALRIFOX: Participant must have mPDAC that has not been previously treated with chemotherapy. If a participant received (neo)adjuvant therapy, tumor recurrence or disease progression must have occurred at least 6 months after completing the last dose of the (neo)adjuvant therapy. * Part…
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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