AXT-1003 Combination With Enzalutamide in Participants With mCRPC

Prior treatment

• Received chemotherapy, immunotherapy, definitive radiotherapy, major surgery, targeted therapy or other anti-tumor treatments within 4 weeks prior to first dose.
• Received palliative radiotherapy within 2 weeks prior to first dose.
• Received traditional Chinese medicine (TCM) therapy with anti-tumor indications within 2 weeks prior to first study treatment.
• Participated in any other clinical trial within 28 days prior to first study treatment.
• History of stroke or other severe cerebrovascular disease within 12 months before enrollment.
• Clinically significant toxicities from any prior therapy (chemotherapy, immunotherapy, radiotherapy, targeted therapy or other investigational treatment) unresolved to Grade ≤ 1 at enrollment, unless deemed no safety risk by the investigator.
• Received live virus vaccines (including attenuated live vaccines) within 28 days prior to dosing.

Other illness

• Uncontrolled or significantly symptomatic cardiovascular disease.
• Known or suspected hypersensitivity to AXT-1003, any of its excipients, or any components of enzalutamide soft capsules.
• History of other prior malignancies, except for curatively treated basal cell carcinoma of skin, squamous cell carcinoma of skin, cervical carcinoma in situ, or other carcinoma in situ with no recurrence for 5 years after treatment.
• Active infection (requiring intravenous antibiotics or hospitalization), active autoimmune diseases and inflammatory diseases.
• Active hepatitis B or hepatitis C infection.
• Known human immunodeficiency virus (HIV) infection and active tuberculosis.

Other

• Active brain metastases or leptomeningeal metastases.

• Age ≥ 18 years.
• ECOG performance status 0-1.
• Histologically/cytologically confirmed prostate adenocarcinoma; neuroendocrine and small cell carcinoma excluded.
• Metastatic disease with evaluable bone lesions (per PCWG3) or measurable soft tissue lesions (per RECIST v1.1).
• Ongoing LHRH agonist/antagonist therapy, except prior bilateral orchiectomy.
• Serum testosterone at castration level (≤50 ng/dL or 1.7 nmol/L) at screening.
• Documented disease progression at screening.
• Adequate organ function.
• Male subjects with childbearing potential partners must use effective contraception through 3 months after last dose.