NCT07533708 A Phase I Clinical Study of HLX3902 in Patients With mCRPC and Other Advanced Tumours
| NCT ID | NCT07533708 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Shanghai Henlius Biotech |
| Condition | mCRPC or Advanced/Metastatic Solid Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2026-07-30 |
| Primary Completion | 2027-06-29 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 48 participants in total. It began in 2026-07-30 with a primary completion date of 2027-06-29.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07533708 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying mCRPC or Advanced/Metastatic Solid Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07533708 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07533708 currently recruiting?
Yes, NCT07533708 is actively recruiting participants. Contact the research team at fuscc2012@163.com for enrollment information.
Where is the NCT07533708 trial being conducted?
This trial is being conducted at Nanchang, China, Naning, China, Nanjing, China, Shanghai, China and 1 additional location.
Who is sponsoring the NCT07533708 clinical trial?
NCT07533708 is sponsored by Shanghai Henlius Biotech. The trial plans to enroll 48 participants.