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.
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
- Conditions the study is for
- mCRPC or Advanced/Metastatic Solid Tumors
- 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.
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- 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.
5 sites in 1 country
China5 sites, 5 recruiting
- 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
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 group | Role | What they receive |
|---|---|---|
| Dose Escalation | Experimental | This 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.
Dose-Limiting Toxicity (DLT)
Measured: At the end of Cycle 1 (each cycle is 4 weeks)
maximum tolerated dose (MTD)
Measured: Up to approximately 2 years
Secondary outcomes (11)
Number of participants with adverse events (AEs)
Measured: Up to approximately 2 years
Number of participants with serious adverse events (SAEs)
Measured: Up to approximately 2 years
Objective response rate (ORR)
Measured: Up to approximately 2 years
disease control rate (DCR)
Measured: Up to approximately 2 years
Duration of response (DOR)
Measured: Up to approximately 2 years
Progression-free survival (PFS)
Measured: Up to approximately 2 years
Overall survival (OS)
Measured: Up to approximately 2 years
Prostate-specific antigen (PSA) response
Measured: Up to approximately 2 years
PK parameters of HLX3902
Measured: Up to approximately 2 years
Incidence of anti-drug antibodies (ADAs) and neutralizing antibodies (NAbs) against HLX3902
Measured: Up to approximately 2 years
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.
- First posted16 Apr 2026
- Study start30 Jul 2026
- Primary completion29 Jun 2027 (estimated)
- Study completion24 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for mCRPC or Advanced/Metastatic Solid TumorsStudies of the same condition, open and under way.
- More trials run by Shanghai Henlius BiotechThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Shanghai Henlius Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07533708
- Acronym / sponsor ID
- HLX3902-FIH101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Shanghai Henlius BiotechIndustry (pharma, biotech, devices)
- Study start
- 30 Jul 2026 (actual)
- Primary completion
- 29 Jun 2027 (estimated)
- Study completion
- 24 May 2028 (estimated)
- First posted
- 16 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation | Experimental | Drug: HLX3902This 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HLX3902HLX3902 will be administered as an intravenous (IV) infusion. | Drug | Dose Escalation |
Primary outcome
Dose-Limiting Toxicity (DLT)
Time frame: At the end of Cycle 1 (each cycle is 4 weeks)
maximum tolerated dose (MTD)
Time frame: Up to approximately 2 years
11 secondary outcomes
Number of participants with adverse events (AEs)
Time frame: Up to approximately 2 years
Number of participants with serious adverse events (SAEs)
Time frame: Up to approximately 2 years
Objective response rate (ORR)
Time frame: Up to approximately 2 years
disease control rate (DCR)
Time frame: Up to approximately 2 years
Duration of response (DOR)
Time frame: Up to approximately 2 years
Progression-free survival (PFS)
Time frame: Up to approximately 2 years
Overall survival (OS)
Time frame: Up to approximately 2 years
Prostate-specific antigen (PSA) response
Time frame: Up to approximately 2 years
PK parameters of HLX3902
Time frame: Up to approximately 2 years
Incidence of anti-drug antibodies (ADAs) and neutralizing antibodies (NAbs) against HLX3902
Time frame: Up to approximately 2 years
PD biomarkers, including peripheral blood cytokines (e.g., IL-2, IL-6, TNF-α, and IFN-γ) and peripheral T-cell activation and proliferation.
Time frame: Up to approximately 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
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?
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; AzTrials last refreshed its copy on 7 Nov 2026.