Using a PARP Inhibitor and Oral Chemotherapy to Treat Advanced Solid Tumors with a Mutation in BRCA1, BRCA2, PALB2, ATM or CHEK2
https://www.facingourrisk.org/research-clinical-trials/study/376/using-a-parp-inhibitor-and-oral-chemotherapy-to-treat-advanced-solid-tumors-with-a-mutation-in-brca1-brca2-palb2-atm-or-chek2
Clinicaltrials.gov identifier:
NCT06177171 (https://clinicaltrials.gov/show/NCT06177171)
Treatment
Phase 1 treatment study for metastatic solid tumors
Study Contact Information:
Contact UC San Francisco Early Phase Cancer Clinical Trials
Phone: 877‑827‑3222
Email: [email protected]
About the Study
This is an early‑phase clinical trial testing a new drug combination for people with advanced or metastatic solid tumors with mutations in BRCA1, BRCA2, PALB2, ATM, or CHEK2.
The study is testing olaparib, a PARP inhibitor already used for some cancers, together with ASTX727, an oral form of chemotherapy. Researchers want to learn whether using these two drugs together is safe, what dose works best, and whether the combination can help slow or shrink cancers with these mutations.
What the Study Involves
All participants will:
- Take olaparib and ASTX727 by mouth in repeating treatment cycles
- Visit the study site regularly for:
- Physical exams
- Blood tests
- Monitoring for side effects
- Imaging scans (such as CT or MRI)
- Provide blood and possibly tumor samples for research
Participants will stay on the medication until their cancer gets worse or comes back. After stopping treatment, participants will be followed for safety for about 30 days, and then checked periodically for up to 2 years.
This Study is Open To:
Participants may be eligible if they:
- Have an advanced or metastatic solid tumor (any solid cancer type)
- Have an inherited (germline) mutation or tumor mutation in one of these genes:
- BRCA1
- BRCA2
- PALB2
- ATM
- CHEK2
- Have already had standard treatments, or no standard treatment is available.
- Participants who have previously received a PARP inhibitor are still eligible.
- Must be at least 3 weeks since last systemic treatment and at least 2 weeks since receiving radiation. Any serious side effects from prior treatments must be managed.
- Must have adequate heart, kidney, liver, and bone marrow function.
Genetic testing must be done before joining the study.
See full inclusion list here.
This Study is Not Open To:
People are not eligible if they:
- Have a diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
- Have not recovered from adverse events from prior treatments.
- Are pregnant or breastfeeding.
See full exclusion list here.
About FORCE
FORCE is a national nonprofit organization, established in 1999. Our mission is to improve the lives of individuals and families affected by adult hereditary cancers.