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NCT07160335 · ClinicalTrials.gov registry record · Phase 1
A Phase I Clinical Study to Evaluate the PK Profile, Efficacy, Safety and Immunogenicity of HLX17 vs. Keytruda® in Multiple Resected Solid Tumors
A Phase 1 study of Non-Small Cell Lung Cancer and Melanoma, sponsored by Shanghai Henlius Biotech.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 174
- Enrollment target
- 20
- Study locations
NCT07160335: Recruiting Phase 1 study of Non-Small Cell Lung Cancer and Melanoma, sponsored by Shanghai Henlius Biotech.
NCT07160335 is a Phase 1 study of Non-Small Cell Lung Cancer and Melanoma that is actively recruiting participants, run by Shanghai Henlius Biotech. The registered enrollment target is 174 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (73% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07160335, a Phase 1 study of Non-Small Cell Lung Cancer and Melanoma, is actively recruiting participants, sponsored by Shanghai Henlius Biotech.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 174 participants
- Enrollment target
- 20
- Study locations
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).
Primary Outcome
Area under the serum concentration-time curve from time 0 to 21 days (AUC0-21d) after the 1st dose
Conditions Studied
Interventions
- DRUG HLX17
- DRUG US-sourced Keytruda®
Study Locations (20)
California
- Oncology Physicians Network (OPN) - Glendale - Glendale
- Oncology Physicians Network (OPN)- Los Alamitos - Los Alamitos
- HCA - Los Angeles
- Los Angeles Cancer Network - Los Angeles
- Oncology Physicians Network (OPN) - San Bernardino - San Bernardino
Florida
- BRCR Global - Deerfield Beach
- D&H National Research Center - Margate
- Ocala Oncology - Ocala
- Mid Florida Hematology and oncology Center - Orange City
Washington
- American Oncology Network Vista Oncology Division - Olympia
- Northwest Medical Specialties PPLC (P1 Trials - Exigent Network ) - Tacoma
Anhui
- The First Affiliated Hospital of Anhui Medical University - Hefei
- The First Affiliated Hospital of Wannan Medical College - Wuhu
Fujian
- Fujian Cancer Hospital - Fuzhou
- The First Affiliated Hospital of Xiamen University - Xiamen
Texas
- Oncology Consulatants (P1 Trials -Exigent Network) - Houston
Beijing Municipality
- Beijing Chest Hospital, Capital Medical University - Beijing
Changsha
- Hunan Provincial Cancer Hospital - Hunan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 174 participants |
| Start Date | 2025-09-26 |
| Est. Completion | 2028-03-27 |
| Phase | Phase 1 |
What NCT07160335 shows while recruiting
NCT07160335 is an interventional study that assigns participants to a tested intervention. The registered 174 participants enrollment target is mid-sized for trials with a published cap, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (73% lower).
The record links to 3 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which HLX17 is the first listed.
NCT07160335 names 20 study sites across 10 states, led by California, Florida, Washington.
Frequently Asked Questions
What is clinical trial NCT07160335 about?
NCT07160335 is a clinical study titled "A Phase I Clinical Study to Evaluate the PK Profile, Efficacy, Safety and Immunogenicity of HLX17 vs. Keytruda® in Multiple Resected Solid Tumors". 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 c...
What is the current status of trial NCT07160335?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 174 participants. The study started on 2025-09-26. Estimated completion is 2028-03-27.
What conditions does trial NCT07160335 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Melanoma, Renal Cell Carcinoma.
What interventions are being tested in trial NCT07160335?
The interventions under investigation include: HLX17 (DRUG), US-sourced Keytruda® (DRUG).
Who is sponsoring clinical trial NCT07160335?
This trial is sponsored by Shanghai Henlius Biotech, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07160335 being conducted?
This trial has 20 study locations across California, Florida, Texas, Washington, Anhui. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07160335's enrollment target sits among peer trials
174 182nd of 454 higher than 273 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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