AXT-1003 plus enzalutamide for advanced prostate cancer that has spread
Tests AXT-1003 with enzalutamide in adults with metastatic castration-resistant prostate cancer.
Plain-language title generated from the registry record
Registry title: AXT-1003 Combination With Enzalutamide in Participants With mCRPC
Key facts
- Where
- Changsha, Guangzhou, Ningbo, and Shanghai, ChinaSee the 4 sites
- Phase
- Phase 1
Where in China
- Hunan Cancer HospitalChangsha, ChinaNot yet recruiting
- Sun Yet-Sen University Cancer CenterGuangzhou, ChinaNot yet recruiting
- The First Affiliated Hospital of Ningbo UniversityNingbo, ChinaTaking people
- Fudan University Shanghai Cancer CenterShanghai, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Axter Therapeutics (Beijing) Co., Ltd
- Trial code
- NCT07897071
- Record updated
- 27 October 2026
- Original description
The purpose of this study is to evaluate the efficacy, and safety of AXT-1003 combined with Enzalutamide in subjects with advanced prostate cancer.Read full original descriptionShow less
An Open-label, Multicenter, Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of AXT-1003 Combination With Enzalutamide in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
The purpose of this study is to evaluate the efficacy, and safety of AXT-1003 combined with Enzalutamide in subjects with advanced prostate cancer.
Inclusion: 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.
Exclusion: 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; 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; Active brain metastases or leptomeningeal metastases.