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A Phase I Clinical Study to Evaluate the PK Profile, Efficacy, Safety and Immunogenicity of HLX17 vs. Keytruda® in Multiple Resected Solid Tumors

NCT07160335 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 174

Last updated 2026-05-15

No results posted yet for this study

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 HLX17 vs. US-sourced Keytruda® in patients with resected non-small cell lung cancer (NSCLC) or melanoma (MEL), or renal cell carcinoma (RCC).

Conditions

Interventions

DRUG

HLX17

Subjects will receive HLX17 (200 mg) on Day 1 of each 3-week cycle

DRUG

US-sourced Keytruda®

Subjects will receive US-sourced Keytruda® (200 mg) on Day 1 of each 3-week cycle

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-26
Primary Completion
2027-04-30
Completion
2028-03-27
FDA Drug
Yes

Countries

  • United States
  • China
  • Georgia
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07160335 on ClinicalTrials.gov