A Phase I Clinical Study of HLX3902 in Patients With mCRPC and Other Advanced Tumours
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Henlius Biotech
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Sequential
Treatments tested in this trial
HLX3902
DrugHLX3902 will be administered as an intravenous (IV) infusion.
Treatment groups
48 Participants
are divided into 1 treatment groupGroup A: Dose EscalationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Dose-Limiting Toxicity (DLT)
Time frame
At the end of Cycle 1 (each cycle is 4 weeks)2
maximum tolerated dose (MTD)
Time frame
Up to approximately 2 yearsSecondary outcomes
1
Number of participants with adverse events (AEs)
Time frame
Up to approximately 2 years2
Number of participants with serious adverse events (SAEs)
Time frame
Up to approximately 2 years3
Objective response rate (ORR)
Time frame
Up to approximately 2 years4
disease control rate (DCR)
Time frame
Up to approximately 2 yearsSponsors and contacts
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Source ClinicalTrials.gov