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mCRPC or Advanced/Metastatic Solid TumorsPhase 1NCT07533708

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

A Phase 1 study testing HLX3902 in people with mCRPC or Advanced/Metastatic Solid Tumors, run by Shanghai Henlius Biotech at 5 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
HLX3902
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
5 sitesChina
Study dates
30 Jul 2026to 24 May 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • 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.

Who cannot join

  • 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.
Show all 15Show fewer
  • 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.
  • Adverse events from prior therapy not resolved to Grade ≤ 1, except for alopecia, ear toxicity, or stable Grade ≤ 2 taxane-related neurotoxicity.
  • History of Grade ≥ 2 immune-related pneumonitis or myocarditis, or severe/life-threatening immune-mediated adverse events during prior immunotherapy.
  • Poorly controlled cardiovascular disease within 6 months, unstable angina, stroke, thromboembolic events, or 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 requiring 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 (e.g., seizures, dementia), or any condition that makes the participant unsuitable per Investigator.

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Dingwei Ye contact

021-64175590-1605

fuscc2012@163.com

5 sites in 1 country

China5 sites, 5 recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang

    Bin Fu, urodoc@126.com

    Recruiting

  • Guangxi Medical University Cancer Hospital

    Naning

    Ruiling Ning, rlning@163.com

    Recruiting

  • Nanjing Drum Tower Hospital

    Nanjing

    Hongqian Guo, 15050589789@126.com

    Recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai

    Dingwei Ye, fuscc2012@163.com

    Recruiting

  • The First Affiliated Hospital of Xiamen University

    Xiamen

    Yanjun Mi, 77@163.com

    Recruiting

Other trials in China

About this study

Official title: A Phase Ia Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of HLX3902 (a STEAP1xCD3xCD28 Trispecific Antibody) in Patients With Metastatic Castration-Resistant Prostate Cancer and Other Advanced Solid Tumours

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.

Being tested
HLX3902

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HLX3902Drug

    HLX3902 will be administered as an intravenous (IV) infusion.

Study groups in NCT07533708
Study groupRoleWhat they receive
Dose EscalationExperimentalThis study is an open-label, first-in-human, Phase Ia clinical trial to evaluate the safety, tolerability, PK profiles, and preliminary efficacy of HLX3902 in patients with mCRPC and other advanced solid tumours.
Receives: Drug: HLX3902

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose-Limiting Toxicity (DLT)

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

  2. maximum tolerated dose (MTD)

    Measured: Up to approximately 2 years

Secondary outcomes (11)

  1. Number of participants with adverse events (AEs)

    Measured: Up to approximately 2 years

  2. Number of participants with serious adverse events (SAEs)

    Measured: Up to approximately 2 years

  3. Objective response rate (ORR)

    Measured: Up to approximately 2 years

  4. disease control rate (DCR)

    Measured: Up to approximately 2 years

  5. Duration of response (DOR)

    Measured: Up to approximately 2 years

  6. Progression-free survival (PFS)

    Measured: Up to approximately 2 years

  7. Overall survival (OS)

    Measured: Up to approximately 2 years

  8. Prostate-specific antigen (PSA) response

    Measured: Up to approximately 2 years

  9. PK parameters of HLX3902

    Measured: Up to approximately 2 years

  10. Incidence of anti-drug antibodies (ADAs) and neutralizing antibodies (NAbs) against HLX3902

    Measured: Up to approximately 2 years

  11. PD biomarkers, including peripheral blood cytokines (e.g., IL-2, IL-6, TNF-α, and IFN-γ) and peripheral T-cell activation and proliferation.

    Measured: Up to approximately 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Apr 2026
  2. Study start30 Jul 2026
  3. Primary completion29 Jun 2027 (estimated)
  4. Study completion24 May 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07533708
Sponsor's protocol ID
HLX3902-FIH101
Status last verified
Aug 2026
First submitted
2 Apr 2026
Last updated
11 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HLX3902 in people with mCRPC or Advanced/Metastatic Solid Tumors, run by Shanghai Henlius Biotech at 5 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dingwei Ye (021-64175590-1605, fuscc2012@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-Limiting Toxicity (DLT) (time frame: At the end of Cycle 1 (each cycle is 4 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07533708.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.

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