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

ConditionsEsophageal and/or Cardia CancerMelanomaUrothelial Carcinoma (UC)
Trial statusRecruiting
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

174 Participants
are divided into 2 treatment groups
Group A: HLX18Experimental treatment 1 intervention
Group B: OPDIVO®Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

AUC0-28d

Time frame
From time 0 to 28 days after the 1st dose(4 weeks)
2

AUCss

Time frame
From time 0 to 28 days after the 4th dose(16 weeks)

Secondary outcomes

1

maximum serum drug concentration (Cmax)

Time frame
up to 16 weeks
2

trough serum drug concentration (Ctrough)

Time frame
up to 16 weeks
3

maximum serum drug concentration at steady state (Cmax,ss)

Time frame
up to 16 weeks
4

trough serum drug concentration at steady state (Ctrough,ss)

Time frame
up to 16 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Henlius Biotech

Lead sponsor

Source ClinicalTrials.gov
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