Who may be eligible for this metastatic castration-resistant prostate cancer clinical trial?

Adults aged 18 years or older with confirmed advanced or metastatic solid tumors, including metastatic castration-resistant prostate cancer following standard treatments, may be eligible. Participants must have good performance status and an expected survival longer than 3 months. Please review eligibility criteria for more details.

Is there any cost to participate in this metastatic castration-resistant prostate cancer clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel expenses and other costs related to participation may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 1

Age: 18Years +

All Genders

ID07533708

Phase I Study of Intravenous HLX3902 in Adults with Metastatic Castration-Resistant Prostate Cancer and Other Advanced Solid Tumors

Q: What is HLX3902 studying for metastatic castration-resistant prostate cancer and other advanced tumors?

HLX3902 is being studied to understand its safety, tolerability, and how it behaves in the body when given to adults with metastatic castration-resistant prostate cancer and other advanced solid tumors. This study aims to find the right dose and gather early information on how the drug affects these cancers. The trial is sponsored by Shanghai Henlius Biotech.

Led by Shanghai Henlius Biotech · Updated on 2026-08-11

Participants Needed

Research Sites

47 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are conducting a first-in-human, open-label Phase I clinical trial to study HLX3902 in adults with metastatic castration-resistant prostate cancer mCRPC and other advanced solid tumors. The study aims to evaluate the safety, tolerability, and pharmacokinetic profiles of HLX3902 while also exploring preliminary efficacy in this patient population. This research is important for understanding how HLX3902 behaves in the body and its potential for treating advanced cancers. Participants will receive HLX3902 administered via intravenous infusion. The trial follows a dose escalation design to determine the maximum tolerated dose and observe any dose-limiting toxicities over treatment cycles lasting four weeks each. The study may continue up to approximately two years to monitor outcomes and drug effects. This trial is sponsored by Shanghai Henlius Biotech. Throughout the study, participants will undergo various assessments including safety monitoring, response evaluations, and laboratory tests. Researchers will measure adverse events, disease control, progression-free survival, and overall survival, as well as biomarkers such as prostate-specific antigen PSA and immune-related markers. Tumor tissue samples will be collected, and participants must agree to effective contraception. The total study duration extends until May 2028, with evaluations conducted regularly to track the treatments effects and participant health.

CONDITIONS

Brief Title

A Phase I Clinical Study of HLX3902 in Patients With mCRPC and Other Advanced Tumours

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Voluntarily signed written informed consent and willing to comply with study procedures.
Age 18 years or older, any gender.
Histologically confirmed advanced or metastatic solid tumors including metastatic castration-resistant prostate cancer after failure of standard therapy.
For mCRPC: progression or refractory status after at least one novel anti-androgen agent and 1-2 taxane-based regimens.
Ongoing surgical or medical castration with serum testosterone ≤ 50 ng/dL.
Documented disease progression (prostate-specific antigen, nodal, visceral, or bone).
At least one measurable lesion according to RECIST v1.1.
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
Expected survival longer than 3 months.
Agreement to provide archived or fresh tumor tissue.
Adequate organ function.
Agreement to use effective contraception for both genders and negative pregnancy test for females of childbearing potential.

You will not qualify if you...

Presence of histological types other than adenocarcinoma in mCRPC or neuroendocrine or small cell differentiation in other solid tumors.
Active or symptomatic central nervous system metastases, carcinomatous meningitis, or spinal cord compression (except stable treated brain metastases meeting criteria).
Active malignancies within two years prior to first dose, except cured carcinoma in situ or basal cell carcinoma of the skin.
Prior STEAP1-targeted therapy or Radium-223/PSMA radionuclide therapy within 6 months.
Major surgery, radiotherapy, chemotherapy, biological therapy, immunotherapy, or endocrine therapy (excluding LHRH/GnRH analogues) within 28 days; small molecule drugs within 14 days.
Vaccination with live vaccines within 28 days.
Use of systemic corticosteroids (>10 mg/day Prednisone equivalent) or other immunosuppressants within 14 days.
Participation in another interventional study or within 4 weeks of ending such a study.
Unresolved adverse events from prior therapy above Grade 1 except alopecia, ear toxicity, or stable Grade ≤ 2 taxane-related neurotoxicity.
History of Grade ≥ 2 immune-related pneumonitis or myocarditis or severe immune-mediated adverse events during prior immunotherapy.
Poorly controlled cardiovascular disease within 6 months or unstable angina, stroke, thromboembolic events, uncontrolled hypertension or arrhythmia.
Evidence of interstitial lung disease or active non-infectious pneumonitis.
Active or suspected autoimmune disease, hypophysitis, or unstable pituitary dysfunction requiring systemic therapy.
Active systemic infectious diseases needing intravenous antibiotics within 2 weeks, active tuberculosis, or positive for HIV, active HBV (HBV DNA ≥ 500 IU/mL), or HCV.
History of organ transplantation, central nervous system diseases within 12 months, or any condition making the participant unsuitable per investigator.

Research Team

Dingwei Ye

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Phase I Study of Intravenous HLX3902 in Adults with Metastatic Castration-Resistant Prostate Cancer and Other Advanced Solid Tumors

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria