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

Recruiting Phase 1 Interventional Study
Esophageal and/or Cardia Cancer Melanoma Urothelial Carcinoma (UC)
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 – 70
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
174 (estimated)
Sponsor
Shanghai Henlius Biotech · Industry
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About This Trial

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 Locations
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Eligibility Criteria
Inclusion Criteria: 1. Participants must have signed and dated an IRB/IEC approved written informed consent form. 2. Aged 18 to 70 years at the time of signing the ICF. 3. 18 kg/m² ≤ BMI ≤ 30 kg/m² and 50 kg ≤ body weight ≤ 85 kg. 4. Histologically confirmed solid tumors (EC/GEJC, Melanoma, or UC) …
Contacts

Chang Chen

+86 138 1686 9003

chenthoracic@163.com

CONTACT