A Multicenter, Randomized, Double-Blind, Parallel-Controlled Phase I Clinical Study to Evaluate the Pharmacokinetic Profile, Efficacy, Safety and Immunogenicity of HLX17 vs. Keytruda® (US-sourced Keytruda®) in Multiple Resected Solid Tumors

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Record identity and dates

Source

ClinicalTrials.gov

Source record ID

NCT07160335

Title field or adapter rule

{'original_value': 'A Multicenter, Randomized, Double-Blind, Parallel-Controlled Phase I Clinical Study to Evaluate the Pharmacokinetic Profile, Efficacy, Safety and Immunogenicity of HLX17 vs. Keytruda® (US-sourced Keytruda®) in Multiple Resected Solid Tumors', 'source_field': 'protocolSection.identificationModule.officialTitle'}

Ingested At

2026-10-31T23:27:36.647620+00:00

Published At

2026-10-20T00:00:00+00:00

Record Updated At

2026-10-20

Source Retrieved At

2026-10-31T22:19:02.163121+00:00

Timestamp Basis

ClinicalTrials.gov API/RSS response retrieval timestamp recorded by Dossier adapter

Date limitation

ClinicalTrials.gov API/RSS response retrieval timestamp recorded by Dossier adapter

Fields recorded by this source

protocolSection.conditionsModule.conditions

["Non-small Cell Lung Cancer", "Melanoma", "Renal Cell Carcinoma"]

protocolSection.statusModule.lastUpdatePostDateStruct

{"date": "2026-10-20", "type": "ACTUAL"}

protocolSection.identificationModule.nctId

"NCT07160335"

protocolSection.identificationModule.officialTitle

"A Multicenter, Randomized, Double-Blind, Parallel-Controlled Phase I Clinical Study to Evaluate the Pharmacokinetic Profile, Efficacy, Safety and Immunogenicity of HLX17 vs. Keytruda\u00ae (US-sourced Keytruda\u00ae) in Multiple Resected Solid Tumors"

protocolSection.statusModule.overallStatus

"ACTIVE_NOT_RECRUITING"

protocolSection.designModule.phases

["PHASE1"]

protocolSection.statusModule.resultsFirstPostDateStruct

null

Study condition terms

• Non-small Cell Lung Cancer (protocolSection.conditionsModule.conditions)
• Melanoma (protocolSection.conditionsModule.conditions)
• Renal Cell Carcinoma (protocolSection.conditionsModule.conditions)

Interventions recorded in this study

• {'armGroupLabels': ['HLX17', 'US-sourced Keytruda®'], 'description': 'Subjects will receive HLX17 (200 mg) on Day 1 of each 3-week cycle', 'name': 'HLX17', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
• {'armGroupLabels': ['US-sourced Keytruda®'], 'description': 'Subjects will receive US-sourced Keytruda® (200 mg) on Day 1 of each 3-week cycle', 'name': 'US-sourced Keytruda®', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])

An intervention appearing in a study record does not establish an effect or an approved use.

Drug names recorded in this source

• HLX17 (protocolSection.armsInterventionsModule.interventions[].name)
• US-sourced Keytruda® (protocolSection.armsInterventionsModule.interventions[].name)

A recorded drug name is not by itself an indication or a condition-specific relationship.

This index keeps the source fields it imported; it may not contain the complete original record. Verify wording and context in the linked source.