A Study of HLX18 vs. OPDIVO® in Multiple Resected Solid Tumors
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorShanghai Henlius Biotech
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).
Eligibility criteria
Qualifiers
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.
Disqualifiers
History of illicit drug use or alcohol abuse within 12 months prior to randomization.
Tumor-specific exclusions: cervical esophageal cancer, Stage IV EC/GEJC, or ocular melanoma.
UC-specific surgical exclusions: status post partial cystectomy or partial nephrectomy.
EC/GEJC treatment violations: failure to receive mandatory preoperative concurrent CRT (mono-therapy is ineligible).
Trial design
Treatments tested in this trial
- HLX18
- OPDIVO®
Treatment groups
174 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov