AXT-1003 plus Enzalutamide in advanced prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1 trial in men with metastatic castration-resistant prostate cancer evaluating the safety and potential activity of the combination of AXT-1003 and Enzalutamide. Phase Ia uses a non-randomized, open-label design to establish the maximum tolerated dose and the recommended dose for expansion. Phase Ib will expand at selected dose levels to explore antitumor activity in a larger cohort. Participants must have measurable disease or evaluable bone lesions, ongoing androgen deprivation therapy, and castrate testosterone levels, with key eligibility confirming adequate organ function and performance status.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

Exclusion Criteria:

1. Received chemotherapy, immunotherapy, definitive radiotherapy, major surgery, targeted therapy or other anti-tumor treatments within 4 weeks prior to first dose.
2. Received palliative radiotherapy within 2 weeks prior to first dose.
3. Received traditional Chinese medicine (TCM) therapy with anti-tumor indications within 2 weeks prior to first study treatment.
4. Participated in any other clinical trial within 28 days prior to first study treatment.
5. Active brain metastases or leptomeningeal metastases.
6. History of stroke or other severe cerebrovascular disease within 12 months before enrollment.
7. Uncontrolled or significantly symptomatic cardiovascular disease.
8. Known or suspected hypersensitivity to AXT-1003, any of its excipients, or any components of enzalutamide soft capsules.
9. 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.
10. 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.
11. Active infection (requiring intravenous antibiotics or hospitalization), active autoimmune diseases and inflammatory diseases.
12. Received live virus vaccines (including attenuated live vaccines) within 28 days prior to dosing.
13. Active hepatitis B or hepatitis C infection.
14. Known human immunodeficiency virus (HIV) infection and active tuberculosis.

Where it's running

• Fudan University Shanghai Cancer Center
  Shanghai, Shanghai Municipality, China Recruiting
• The First Affiliated Hospital of Ningbo University
  Ningbo, Zhejiang, China Recruiting
• Sun Yet-Sen University Cancer Center
  Guangzhou, Guangdong, China Not yet recruiting
• Hunan Cancer Hospital
  Changsha, Hunan, China Not yet recruiting

Study contacts

• Study coordinator: Sara Hua, APM
• Email: sara.hua@axtertx.com
• Phone: 0086+15624980624

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.