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Active, not recruiting Phase 1 Interventional

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

ClinicalTrials.gov ID: NCT07160335

Public ClinicalTrials.gov record NCT07160335. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 23, 2026, 2:01 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID
NCT07160335
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 1
Lead sponsor
Shanghai Henlius Biotech
Industry
Enrollment
174 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 85 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 26, 2025 (Actual)
Primary completion
Apr 30, 2027 (Estimated)
Completion
Mar 27, 2028 (Estimated)
Last update posted
Oct 20, 2026

2025 – 2028

United States locations

U.S. sites
12
U.S. states
4
U.S. cities
11
Facility City State ZIP Site status
Oncology Physicians Network (OPN) - Glendale Glendale California 91203 —
Oncology Physicians Network (OPN)- Los Alamitos Los Alamitos California 90720 —
HCA Los Angeles California 64132 —
Los Angeles Cancer Network Los Angeles California 92801 —
Oncology Physicians Network (OPN) - San Bernardino San Bernardino California 91203 —
BRCR Global Deerfield Beach Florida 33326 —
D&H National Research Center Margate Florida 33063 —
Ocala Oncology Ocala Florida 34474 —
Mid Florida Hematology and oncology Center Orange City Florida 32763 —
Oncology Consulatants (P1 Trials -Exigent Network) Houston Texas 77030 —
American Oncology Network Vista Oncology Division Olympia Washington 98506 —
Northwest Medical Specialties PPLC (P1 Trials - Exigent Network ) Tacoma Washington 98405 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 57 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT07160335, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 20, 2026 · Synced Oct 23, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT07160335 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →