A Study of HLX18 vs. OPDIVO® in Multiple Resected Solid Tumors

Sponsor
Shanghai Henlius Biotech
Study ID
NCT07518043
Phase
PHASE1
Status
Recruiting
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Conditions

  • Esophageal and/or Cardia Cancer
  • Melanoma
  • Urothelial Carcinoma (UC)

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • HLX18 — DRUG
    Participants will receive HLX18 (480 mg) on Day 1 of each 4-week cycle
  • OPDIVO® — DRUG
    Participants will receive OPDIVO® (480 mg) on Day 1 of each 4-week cycle

Study Details

This is a multicenter, randomized, double-blind, parallel-controlled phase I clinical study to evaluate the similarity in PK profile, efficacy, safety and immunogenicity of HLX18 and OPDIVO® in patients with resected esophageal or gastroesophageal junction cancer (EC/GEJC), melanoma (MEL), or urothelial carcinoma (UC).

Key Dates

First listed
Apr 8, 2026
Start date
Jul 15, 2026
Status verified
Jul 2026
Primary completion
Aug 12, 2027
Completion
Jun 13, 2028

Study Design

Enrollment
174 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: HLX18
    Participants will receive HLX18 (480 mg) on Day 1 of each 4-week cycle, until 12 months after the randomization (nearly 13 cycles) or investigator-assessed disease recurrence, death, initiation of new anti-tumor therapy, unacceptable drug toxicity, withdrawal of informed consent form, or study termination (whichever occurs first).
  • Active Comparator: OPDIVO®
    Participants will receive OPDIVO® (480 mg) on Day 1 of each 4-week cycle, for a total of 4 cycles (16 weeks). After 4 cycles, all participants in the OPDIVO® group will receive HLX18 480 mg on Day 1 of each 4-week cycle until 12 months after the randomization (nearly 13 cycles) or investigator-assessed disease recurrence, death, initiation of new anti-tumor therapy, unacceptable drug toxicity, withdrawal of informed consent form, or study termination (whichever occurs first).

Primary Outcome Measure

AUC0-28d [ Time Frame: From time 0 to 28 days after the 1st dose(4 weeks) ]

Central Contacts

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