Study of ACE-86225106 to Treat Patients With Advanced Solid Tumors

Launched by ACERAND THERAPEUTICS (SHANGHAI) LIMITED · Apr 18, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called ACE-86225106, which is a type of medication known as a PARP inhibitor. The goal of the study is to find out if this treatment is safe and effective for adults with advanced solid tumors, including certain types of cancer like ovarian, breast, and prostate cancer that have specific genetic mutations (BRCA1 or BRCA2). The trial is currently looking for participants who are generally healthy enough to handle the treatment and have cancers that are hard to treat or have not responded to standard therapies.

To be eligible for the trial, participants need to be adults who can give their consent, have advanced solid tumors that meet specific criteria, and have a life expectancy of at least three months. They should also have good organ function and be able to provide samples for testing. Throughout the trial, participants will receive regular medical check-ups to monitor their health and the effects of the treatment. It's important to note that certain health conditions or prior treatments may prevent someone from joining the study. This trial could offer hope for patients who have limited treatment options for their cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Provide written informed consent;
• • 2. Advanced solid tumors, difficult to treat or intolerant to standard treatment, suitable for investigational treatment;
• • 3. Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
• • 4. Has a life expectancy of at least 3 months;
• • 5. Has measurable disease per RECIST 1.1, castration-resistant prostate Ccancer (CRPC) patients can be assessed according to PCWG3;
• • 6. Adequate organ function and bone marrow function;
• • 7. Can provide tumor specimens and blood samples for Homologous Recombination Deficiency (HRD)/ Homologous Recombination Repair (HRR) related gene testing.
• Exclusion Criteria:
• • 1. Receiving any anti-cancer drugs, major surgery, extensive radiation therapy, or local radiation therapy within protocol-defined wash-out period;
• • 2. Concomitant use of medications or herbal supplements known to be strong or moderate inhibitors or inducers of cytochrome P450 3A4 (CYP3A4);
• • 3. Receiving continuous corticosteroid treatment with a dose of prednisone greater than 10 mg/day or an equivalent dose.
• • 4. Receiving continuous treatment with prednisone at a dose of \>10 mg/d or other corticosteroids at an equivalent dose for any reason.
• • 5. Any previous treatment-related toxicities have not recovered, i.e., to ≤ Grade 1 (as evaluated by NCI-CTCAE v5), except alopecia and other Grade 2 toxicities that are deemed not to affect the conduct of the study, as assessed by the sponsor and the clinical investigator.
• • 6. Spinal cord compression or brain metastases unless asymptomatic, treated and stable.
• • 7. Severe cardiovascular disorders.
• • 8. Myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with evidence suggesting possible MDS/AML.
• • 9. Concomitant diseases or conditions that would preclude the absorption of the investigational product.
• • 10. Active infections, or a known history of HIV infection, or a known active hepatitis B or C, or a known active tuberculosis.
• • 11. Other malignancies that require treatment within 3 years prior to first dose of study investigational product.
• • 12. Conditions with rapid deterioration during the screening period.
• • 13. Known allergy or hypersensitivity to the investigational product or any of the excipients of the investigational product.
• • 14. Has other medical conditions that at the discretion of investigator interfere with safety or efficacy evaluation, or affect treatment compliance.