A Study of ASP3082 in Adults With Advanced Solid Tumors (NCT05382559)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. 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).
2. 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
3. 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.
4. Participant consents to provide tumor specimen in a tissue block or unstained serial slides or a tumor biopsy (core needle biopsy or excision) obtained after the last interventional treatment, but prior to start of study intervention. Participant also consents to provide a sample for tumor biopsy during the treatment period as indicated in the study protocol. If a participant cannot provide a fresh tissue biopsy sample, the site should consult with the sponsor/study medical monitor.
5. Participant has at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
6. Participant has an ECOG performance status of 0, 1 or 2 for dose escalation, and 0 or 1 for dose expansion.
7. Participant's last dose of prior antineoplastic therapy, including any immunotherapy, was 21 days or 5 half-lives, whichever is shorter, prior to initiation of study intervention administration.
8. Participant has completed any radiotherapy (including stereotactic radiosurgery) at least 14 days prior to the start of study intervention administration. Participants must have recovered from all radiation-related toxicities, not require corticosteroids (NOTE: Physiologic replacement dose of hydrocortisone or its equivalent \[defined as up to 30 mg per day of hydrocortisone, 2 mg per day of dexamethasone, or up to 10 mg per day of prednisone\] is permitted), and not have active radiation pneumonitis. A 1-week washout is permitted for palliative radiation (\<= 2 weeks of radiotherapy) to non-central nervous system disease.
9. Participant's adverse events \[AEs\] (excluding alopecia) from prior therapy have improved to grade 1 or baseline within 14 days prior to start of study intervention (or prior to staring SoC chemotherapy, for first line (1L) participants receiving Nab-P+GEM FOLFIRINOX or NALIRIFOX.
10. Participant has adequate organ function as indicated by protocol laboratory value parameters (If a participant has received a recent blood transfusion, the laboratory tests must be obtained \>= 14 days after any blood transfusion.).
11. Female participant is not pregnant, confirmed by pregnancy test and medical evaluation by interview, and at least 1 of the following conditions apply:
12. Not a woman of childbearing potential (WOCBP).

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (66 Sites)

• City of Hope National Medical Center — Duarte, California
• UCLA Santa Monica Hematology Oncology — Santa Monica, California
• Denver HealthONE Drug Development Unit — Denver, Colorado
• Smilow Cancer Center at Yale New Haven Hospital — New Haven, Connecticut
• Georgetown University Hospital — Washington D.C., District of Columbia
• University of Florida, Davis Cancer Center — Gainesville, Florida
• Florida Cancer Specialist — Lake Mary, Florida
• Florida Cancer Specialists & Research Institute Sarasota — Sarasota, Florida
• University of Kansas Medical Center — Westwood, Kansas
• Beth Israel Deaconess Medical Center — Boston, Massachusetts
• Dana Farber Cancer Institute — Boston, Massachusetts
• Trinity Health Ann Arbor Hospital — Ypsilanti, Michigan
• Washington University School of Medicine — St Louis, Missouri
• Hackensack University Medical Center — Hackensack, New Jersey
• Roswell Park Cancer Institute — Buffalo, New York
• Columbia University - Herbert Irving Comprehensive Cancer Center — New York, New York
• Memorial Sloan Kettering Cancer Center — New York, New York
• University of Rochester Medical Center James P. Wilmot Cancer Center — Rochester, New York
• Case Western — Cleveland, Ohio
• Taylor Cancer Research Center — Maumee, Ohio
• Oregon Health and Science University — Portland, Oregon
• SCRI Oncology Partners — Nashville, Tennessee
• Vanderbilt University Medical Center — Nashville, Tennessee
• NEXT Oncology — San Antonio, Texas
• NEXT Oncology - Virginia Cancer Specialists — Fairfax, Virginia

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.