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

This study is a Phase I/II, open-label, multicentre study of ACE-86225106 administered orally in patients with advanced solid tumors.

Inclusion criteria

• Provide written informed consent;
• Advanced solid tumors, difficult to treat or intolerant to standard treatment, suitable for investigational treatment;
• Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
• Has a life expectancy of at least 3 months;
• Has measurable disease per RECIST 1.1, castration-resistant prostate Ccancer (CRPC) patients can be assessed according to PCWG3;
• Adequate organ function and bone marrow function;
• Can provide tumor specimens and blood samples for Homologous Recombination Deficiency (HRD)/ Homologous Recombination Repair (HRR) related gene testing.

Exclusion criteria

• Receiving any anti-cancer drugs, major surgery, extensive radiation therapy, or local radiation therapy within protocol-defined wash-out period;
• Concomitant use of medications or herbal supplements known to be strong or moderate inhibitors or inducers of cytochrome P450 3A4 (CYP3A4);
• Receiving continuous corticosteroid treatment with a dose of prednisone greater than 10 mg/day or an equivalent dose.
• Receiving continuous treatment with prednisone at a dose of >10 mg/d or other corticosteroids at an equivalent dose for any reason.
• 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.
• Spinal cord compression or brain metastases unless asymptomatic, treated and stable.
• Severe cardiovascular disorders.
• Myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with evidence suggesting possible MDS/AML.
• Concomitant diseases or conditions that would preclude the absorption of the investigational product.
• Active infections, or a known history of HIV infection, or a known active hepatitis B or C, or a known active tuberculosis.
• Other malignancies that require treatment within 3 years prior to first dose of study investigational product.
• Conditions with rapid deterioration during the screening period.
• Known allergy or hypersensitivity to the investigational product or any of the excipients of the investigational product.
• Has other medical conditions that at the discretion of investigator interfere with safety or efficacy evaluation, or affect treatment compliance.