Not Yet RecruitingPhase 1

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

48 participantsStarted 2026-05-25

Plain-language summary

This study is an open-label first-in-human phase I clinical study to evaluate the safety, tolerability, and pharmacokinetic characteristics of HLX3902 in patients with mCRPC and other advanced solid tumours.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Voluntarily signed written informed consent and willing to comply with study procedures.
✓. Age: ≥ 18 years, regardless of gender.
✓. 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.
✓. mCRPC specifics: 1）Progression or refractory status after ≥ 1 novel anti-androgen agent and failure of 1-2 taxane-based regimens.

Exclusion criteria

✕. Presence of histological types other than adenocarcinoma in mCRPC; or neuroendocrine or small cell differentiation in other solid tumours.
✕. Active or symptomatic central nervous system metastases, carcinomatous meningitis, or spinal cord compression (stable treated brain metastases meeting protocol criteria are allowed).
✕. Active malignancies within two years prior to the 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.
✕. Systemic corticosteroids (\> 10 mg/day Prednisone equivalent) or other immunosuppressants within 14 days.
✕. Currently participating in another interventional study or within 4 weeks of the end of treatment in such a study.

What they're measuring

Dose-Limiting Toxicity (DLT)

Timeframe: At the end of Cycle 1 (each cycle is 4 weeks)

maximum tolerated dose (MTD)

Timeframe: Up to approximately 2 years

Trial details

NCT IDNCT07533708

SponsorShanghai Henlius Biotech

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-06-29

Contact for this trial

Dingwei Ye

021-64175590-1605 fuscc2012@163.com

View on ClinicalTrials.gov More mCRPC or Advanced/Metastatic Solid Tumors trials