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HLX17 vs. Keytruda® for Resected Solid Tumors

This study is comparing a drug called HLX17 to Keytruda® (a standard cancer treatment) in people who have had surgery for non-small cell lung cancer, melanoma, or renal cell carcinoma (kidney cancer). The main goal is to see how HLX17 moves through your body and how similar it is to Keytruda®. Researchers will also look at how well HLX17 works, its safety, and if your body develops an immune response to it. The study plans to enroll 174 participants aged 18 to 85. The current recruitment status is unclear.

Study design
This is a Phase 1, multicenter, randomized, double-blind study, meaning participants are randomly assigned to receive either HLX17 or Keytruda®, and neither you nor your doctor will know which drug you are receiving. It plans to enroll 174 participants.
What's involved
Participants will receive either HLX17 or Keytruda® on Day 1 of each 3-week cycle. The study measures drug levels in your body for up to 18 weeks after the first dose.
Compensation
Not stated in the trial record.
Follow-up
The study measures drug levels in your body for up to 21 days after the first dose and up to 21 days after the sixth dose (which is 18 weeks after the first dose).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07160335

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

Active, Not Recruiting
PHASE1Ages 18–85InterventionalTreatment
Shanghai Henlius Biotech
~174 participants
Updated 2026-08-18 on ClinicalTrials.gov
What's tested:HLX17US-sourced Keytruda®

At a glance

Recruiting sites
0 of 69 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
AUC0-21d
Measured over rom time 0 to 21 days after the 1st dose (3 weeks)
+1 more outcome measured

Conditions

Non-small Cell Lung Cancer
Melanoma
Renal Cell Carcinoma

Explore related trials

Lung Non-Small Cell CarcinomaMelanomaRenal Cell Carcinoma

Where it's being run

69 sites across 28 states
Turkey (Türkiye)8
Georgia7
California5
Florida4
Shandong4
Shanghai Municipality4
Zhejiang4
Hubei3

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

NSCLC patients after complete resection OR
Melanoma following complete resection OR
Renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. 5. Have a performance status of 0 on the Eastern Cooperative Oncology Group (ECOG) Performance Status within 7 days prior to the first dose in this study. 6. Have a life expectancy of at least 12 weeks. 7. Have adequate organ function as indicated by the following laboratory values (no blood transfusions, or treatment with albumin, recombinant human thrombopoietin or colony-stimulating factor within 14 days prior to the first dose in this study) 8. Female patients must meet one of the following conditions:
be tested negative for serum/urine pregnancy test within 7 days prior to the randomization, and
agree to use contraception methods with an annual failure rate of \< 1% or to remain abstinent (avoid heterosexual intercourse from signing the ICF to at least 6 months after the last dose of the study drug) (a contraceptive method with an annual failure rate of \< 1% includes bilateral tubal ligation, male sterilization, correct use of hormonal contraceptives that can inhibit ovulation, hormone-releasing intrauterine devices and copper-containing intrauterine devices or condoms), and
not breastfeed 9. Male patients must: agree to remain abstinent (avoid heterosexual intercourse) or take contraception measures as follows: male patients with a pregnant partner or a partner of childbearing potential must remain abstinent or use condoms to prevent drug exposure to the embryo during study treatment and for at least 6 months after the last dose of study drug. Periodic abstinence (e.g., contraception based on calendar day, ovulatory phase, basal body temperature, or postovulatory phase) and external ejaculation are ineligible methods of contraception.

What this trial measures

  • AUC0-21drom time 0 to 21 days after the 1st dose (3 weeks)

    Area under the serum concentration-time curve from time 0 to 21 days (AUC0-21d) after the 1st dose

  • AUCssfrom time 0 to 21 days after the 6th dose (18 weeks)

    Area under the serum concentration-time curve within a dosing interval at steady state (AUCss) after the 6th dose