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

NCT07533708 | Not Yet Recruiting Phase 1

• 1 other identifier: HLX3902-FIH101
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

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.

Conditions

mCRPC or Advanced/Metastatic Solid Tumors

Outcome Measures

Primary Outcomes (2)

• Dose-Limiting Toxicity (DLT)

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

• maximum tolerated dose (MTD)

  Up to approximately 2 years

Secondary Outcomes (11)

• Number of participants with adverse events (AEs)

  Up to approximately 2 years

• Number of participants with serious adverse events (SAEs)

  Up to approximately 2 years

• Objective response rate (ORR)

  Up to approximately 2 years

• disease control rate (DCR)

  Up to approximately 2 years

• Duration of response (DOR)

  Up to approximately 2 years

Study Arms (1)

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.

Drug: HLX3902

Interventions

HLX3902 DRUG

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

Dose Escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• ）Ongoing surgical or medical castration (gonadotropin-releasing hormone agonist or antagonist) with serum testosterone ≤ 50 ng/dL.
• ）Documented disease progression (prostate-specific antigen, nodal, visceral, or bone) .
• \. 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Shanghai Henlius Biotech: lead

Central Study Contacts

Dingwei Ye

CONTACT

021-64175590-1605; fuscc2012@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2026
• First Posted: April 16, 2026
• Study Start (Estimated): May 25, 2026
• Primary Completion (Estimated): June 29, 2027
• Study Completion (Estimated): May 24, 2028
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share