NCT07533708RecruitingPhase 1
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
Shanghai Henlius Biotech5 sites in 1 country48 target enrollmentStarted: July 30, 2026Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Enrollment
- 48
- Locations
- 5
- Primary Endpoint
- Dose-Limiting Toxicity (DLT)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
- •ECOG Performance Status of 0-
- •Expected survival exceeding 3 months.
- •Agreement to provide archived or fresh tumour tissue.
- •Adequate organ function.
- •Agreement to use effective contraception for both genders and negative pregnancy test for females of childbearing potential.
Exclusion Criteria
- •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.
Arms & Interventions
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.
Intervention: HLX3902 (Drug)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- 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)
- Progression-free survival (PFS)(Up to approximately 2 years)
- Overall survival (OS)(Up to approximately 2 years)
- Prostate-specific antigen (PSA) response(Up to approximately 2 years)
- PK parameters of HLX3902(Up to approximately 2 years)
- Incidence of anti-drug antibodies (ADAs) and neutralizing antibodies (NAbs) against HLX3902(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.(Up to approximately 2 years)
Investigators
Study Sites (5)
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