New Triple-Action drug takes on Hard-to-Treat cancers
NCT ID NCT07533708
First seen Jun 27, 2026 · Last updated Aug 12, 2026 · Updated 2 times
Summary
This early-phase study tests a new drug called HLX3902 in about 48 people with advanced prostate cancer or other solid tumors that have stopped responding to standard treatments. The main goal is to check the drug's safety and find the best dose. The drug is designed to help the immune system attack cancer cells more effectively.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 48 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2026
- Expected to finish
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May 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
5 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Fudan University Shanghai Cancer Center
RECRUITINGShanghai, China
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Guangxi Medical University Cancer Hospital
RECRUITINGNaning, China
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Nanjing Drum Tower Hospital
RECRUITINGNanjing, China
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The First Affiliated Hospital of Nanchang University
RECRUITINGNanchang, China
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The First Affiliated Hospital of Xiamen University
RECRUITINGXiamen, China
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Other studies related to the condition(s) this trial covers.
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- Gut bacteria may hold clues to why some cancer treatments work better
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- Can PET scan signals predict who beats lung cancer with immunotherapy?