Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING 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

NCT07160335 · View on ClinicalTrials.gov ↗

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).

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

FieldValue
Enrollment Target 174 participants
Start Date 2025-09-26
Est. Completion 2028-03-27
Phase Phase 1

Sponsor

Shanghai Henlius Biotech

6 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07160335

The ClinicalTrials.gov registry entry for NCT07160335 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 174 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Shanghai Henlius Biotech, which has 6 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 3 conditions, with Melanoma appearing as the primary indexed condition, and to 2 interventions — of which HLX17 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT07160335 reports 20 study locations spanning 10 distinct geographic areas — top geographies include California, Florida, Washington. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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: Melanoma, Non-small Cell Lung Cancer, Renal Cell Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT07160335?

The interventions under investigation include: HLX17 (DRUG), US-sourced Keytruda® (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07160335?

This trial is sponsored by Shanghai Henlius Biotech, which has 6 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial