A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HLX3901 in Patients With Advanced SCLC or NEC

Sponsor
Shanghai Henlius Biotech
Study ID
NCT07416695
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • HLX3901 — DRUG
    • HLX3901 will be administered as an intravenous (IV) infusion.

Study Details

This study is an open-label first-in-human phase I clinical study to evaluate the safety, tolerability, and pharmacokinetic characteristics of HLX3901 in patients with Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma.

Key Dates

Start date
Apr 17, 2026
Status verified
Apr 2026
Primary completion
May 30, 2028
Completion
Jun 30, 2029

Study Design

Enrollment
138 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase Ia：Dose Escalation and Backfill
    A total of seven dose escalations were preset: Dose1, Dose2, Dose3, Dose4, Dose5, Dose6, and Dose7. The backfill cohort will enrolls 2 to 3 dose groups.
  • Experimental: Experimental: Phase Ib：Dose Expansion
    Participants will receive the RP2D identified in Dose Escalation Study .

Primary Outcome Measure

The Dose-Limiting Toxicity (DLT) of HLX3901 within 28 days after the first Administration [ Time Frame: From first dose to the end of Cycle 1 (each cycle is 4 weeks) ]

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