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

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).

Trial Details

NCT ID
NCT07518043
Phase
PHASE1
Sponsor
Shanghai Henlius Biotech
Status
RECRUITING
Cancer Type
Melanoma
Interventions
  • HLX18
  • OPDIVO®
Locations (sample)
  • Fuzhou, China|26.06139,119.30611
  • Hangzhou, China|30.29365,120.16142
  • Luoyang, China|34.67345,112.43684
  • Tianjin, China|39.14222,117.17667
  • Wenzhou, China|27.99942,120.66682

Key Eligibility Criteria

  • Participants must have signed and dated an IRB/IEC approved written informed consent form.
  • Aged 18 to 70 years at the time of signing the ICF.
  • 18 kg/m² ≤ BMI ≤ 30 kg/m² and 50 kg ≤ body weight ≤ 85 kg.
  • Histologically confirmed solid tumors (EC/GEJC, Melanoma, or UC) status post R0 resection.

For full eligibility, visit ClinicalTrials.gov.

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