HLX3902 first-in-human study in mCRPC and advanced solid tumors

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, open-label, first-in-human trial of HLX3902 for patients with mCRPC or other advanced/metastatic solid tumors who have exhausted standard therapies. The study prioritizes safety, tolerability, and pharmacokinetics, enrolling adults with measurable disease and adequate organ function. Participants must have progressed after prior anti-androgen and taxane therapy, maintain castration levels of testosterone, have an ECOG 0-1, and provide tumor tissue samples. Multiple sites in China will recruit, with ongoing assessment of adverse events, dosing, and preliminary activity signals. The trial aims to establish a recommended dose for further studies and characterize how HLX3902 is processed in the body.

Why it matters

Who can join: the full rules

Inclusion Criteria

1. Voluntarily signed written informed consent and willing to comply with study procedures.
2. Age: ≥ 18 years, regardless of gender.
3. Histologically confirmed advanced or metastatic solid tumours (e.g., metastatic castration-resistant prostate cancer (mCRPC), non-small cell lung cancer, or gastric cancer) following failure of standard therapy.
4. mCRPC specifics: 1）Progression or refractory status after ≥ 1 novel anti-androgen agent and failure of 1-2 taxane-based regimens.

2）Ongoing surgical or medical castration (gonadotropin-releasing hormone agonist or antagonist) with serum testosterone ≤ 50 ng/dL.

3）Documented disease progression (prostate-specific antigen, nodal, visceral, or bone) .

5\. Presence of at least one measurable lesion per RECIST criteria version 1.1. 6. ECOG Performance Status of 0-1. 7. Expected survival exceeding 3 months. 8. Agreement to provide archived or fresh tumour tissue. 9. Adequate organ function. 10. Agreement to use effective contraception for both genders and negative pregnancy test for females of childbearing potential.

Exclusion Criteria

1. Presence of histological types other than adenocarcinoma in mCRPC; or neuroendocrine or small cell differentiation in other solid tumours.
2. Active or symptomatic central nervous system metastases, carcinomatous meningitis, or spinal cord compression (stable treated brain metastases meeting protocol criteria are allowed).
3. Active malignancies within two years prior to the first dose, except cured carcinoma in situ or basal cell carcinoma of the skin.
4. Prior STEAP1-targeted therapy, or Radium-223/PSMA radionuclide therapy within 6 months.
5. Major surgery, radiotherapy, chemotherapy, biological therapy, immunotherapy, or endocrine therapy (excluding LHRH/GnRH analogues) within 28 days; small molecule drugs within 14 days.
6. Vaccination with live vaccines within 28 days.
7. Systemic corticosteroids (\> 10 mg/day Prednisone equivalent) or other immunosuppressants within 14 days.
8. Currently participating in another interventional study or within 4 weeks of the end of treatment in such a study.
9. Adverse events from prior therapy not resolved to Grade ≤ 1, except for alopecia, ear toxicity, or stable Grade ≤ 2 taxane-related neurotoxicity.
10. History of Grade ≥ 2 immune-related pneumonitis or myocarditis, or severe/life-threatening immune-mediated adverse events during prior immunotherapy.
11. Poorly controlled cardiovascular disease within 6 months, unstable angina, stroke, thromboembolic events, or uncontrolled hypertension or arrhythmia.
12. Evidence of interstitial lung disease, or active non-infectious pneumonitis.
13. Active or suspected autoimmune disease, hypophysitis, or unstable pituitary dysfunction requiring systemic therapy.
14. Active systemic infectious diseases requiring intravenous antibiotics within 2 weeks, active tuberculosis, or positive for HIV, active HBV (HBV DNA ≥ 500 IU/mL), or HCV.
15. History of organ transplantation, central nervous system diseases within 12 months (e.g., seizures, dementia), or any condition that makes the participant unsuitable per Investigator.

Where it's running

• The First Affiliated Hospital of Nanchang University
  Nanchang, China Recruiting
• Guangxi Medical University Cancer Hospital
  Naning, China Recruiting
• Nanjing Drum Tower Hospital
  Nanjing, China Recruiting
• Fudan University Shanghai Cancer Center
  Shanghai, China Recruiting
• The First Affiliated Hospital of Xiamen University
  Xiamen, China Recruiting

Study contacts

• Study coordinator: Dingwei Ye
• Email: fuscc2012@163.com
• Phone: 021-64175590-1605

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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.