A Phase I Clinical Study to Evaluate the PK Profile, Efficacy, Safety and Immunogenicity of HLX17 vs. Keytruda® in Multiple Resected Solid Tumors
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.
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
- 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 25, 2025
- Primary completion
- Apr 29, 2027
- Completion
- Mar 26, 2028
- Last update posted
- Aug 17, 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 Aug 17, 2026 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07160335 live on ClinicalTrials.gov.