A Study of HLX18 vs. OPDIVO® in Multiple Resected Solid Tumors (NCT07518043) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Study of HLX18 vs. OPDIVO® in Multiple Resected Solid Tumors
174 participantsStarted 2026-06-30
Plain-language summary
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).
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion 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 EC/GEJC: residual pathologic disease (non-pCR) following neoadjuvant chemoradiotherapy and R0 resection.
✓. For Melanoma: Stage IIB-IV after complete surgical resection with documented negative margins.
✓. For UC: High-risk muscle-invasive urothelial carcinoma (MIUC) following radical resection (R0).
✓. Documented disease-free status (no recurrence) by imaging and physical exam within 4 weeks prior to randomization.
Exclusion criteria
✕. 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).
What they're measuring
1
AUC0-28d
Timeframe: From time 0 to 28 days after the 1st dose(4 weeks)
2
AUCss
Timeframe: From time 0 to 28 days after the 4th dose(16 weeks)