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Non-small Cell Lung CancerPhase 1NCT07160335

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 testing HLX17 and US-sourced Keytruda® in people with Non-small Cell Lung Cancer and Melanoma, run by Shanghai Henlius Biotech at 69 sites in 4 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
HLX17 and US-sourced Keytruda®
Could I receive a placebo?
No, everyone receives an active treatment
How many people
174 participants
Where
69 sitesin 4 countries
Study dates
26 Sep 2025to 27 Mar 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants must have signed and dated an Institutional Review Board/Independent Ethics Committee (IRB/IEC) approved written informed consent form (ICF) in accordance with regulatory and institutional guidelines.
  • At least 18 years and no older than 85 years (including 85 years old) at the time of signing the ICF.
  • 18 kg/m2 ≤ body mass index (BMI) ≤ 30 kg/m2 and 50 kg ≤ body weight ≤ 85 kg.
  • The patient with one of the following resected solid tumors:
  • NSCLC patients after complete resection OR
  • Melanoma following complete resection OR
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  • Renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.
  • 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.
  • Have a life expectancy of at least 12 weeks.
  • 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)
  • Female patients must meet one of the following conditions:
  • Menopause (defined as no menstruation for at least 1 year with no confirmed cause other than menopause), or
  • Surgically sterilized (removal of the ovaries and/or uterus), or
  • Fertile, but must:
  • 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
  • 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.

Who cannot join

  • Pregnant or lactating women.
  • History of illicit drug use or alcohol abuse within 12 months prior to randomization in the investigator's judgment.
  • Participants with NSCLC have two synchronous primary non-small cell lung cancers or other histopathological types (such as mixed adenosquamous carcinoma, small cell lung cancer, or neuroendocrine carcinoma)； known positive for EGFR sensitive mutations or ALK fusion. EGFR sensitive mutations include: exon 19 deletion mutation (19DEL) and exon 21 point mutation (21L858R).
  • Participants with MEL have mucosal or ocular melanoma.
  • Participants with RCC have pre-existing brain or bone metastatic lesions, or residual thrombus in the renal vein or vena cava after nephrectomy.
  • Participants with other primary active malignancies within 5 years or at the same time prior to randomization.
Show all 24Show fewer
  • Have received an organ or bone marrow transplantation prior to randomization or scheduled for transplantation during the study.
  • Presence of central nervous system (CNS) metastases and/or carcinomatous meningitis.
  • Symptomatic cerebrovascular disease or known myocardial infarction or poorly controlled arrhythmia (including QTcF intervals ≥ 450 ms for males and ≥ 470 ms for females calculated by Fridericia's formula) within 6 months prior to randomization.
  • Chronic heart failure (Class III to IV based on NYHA classification) or an LVEF (left ventricular ejection fraction) assessed with the doppler echocardiography less than 50%.
  • Peripheral neuropathy greater than or equal to Grade 2 (CTCAE).
  • Known human immunodeficiency virus (HIV) infection (or positive anti-HIV during screening), or known Hepatitis B (or positive test for HBsAg or HBcAb and positive test for HBV-DNA during screening), or known Hepatitis C (or positive tests for HCV antibody and HCV-RNA during screening), or known Hepatitis B and C co-infection (or positive test for HBsAg or HBcAb and positive test for HCV antibody during screening), or active pulmonary tuberculosis within 6 months prior to randomization.
  • Known interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, and severe lung function abnormalities that may impede the investigators' diagnosis and management of drug-related pulmonary toxicity prior to screening.
  • Known severe allergic or anaphylactic reactions to pembrolizumab or any other monoclonal antibody or any components of the investigational medicinal products.
  • Known active or suspected autoimmune diseases. Patients with stable disease who do not require systemic immunosuppressive therapy may also participate.
  • Unstable hyperthyroidism or hypothyroidism at screening.
  • Have received live vaccines within 28 days prior to the first dose in this study (Inactivated viral vaccines for seasonal influenza are allowed).
  • Treatment with systemic corticosteroids (> 10 mg/day prednisone efficacy dosage) or other immunosuppressive drugs within 14 days prior to the first dose or during the study. However, participants are allowed to be enrolled under the following conditions: in the absence of active autoimmune disease, participants are allowed to use topical or inhaled steroids and adrenal hormone replacement therapy at dosages equivalent to ≤ 10 mg/day of prednisone efficacy.
  • Any active infection requiring systemic therapy within 1 month prior to the first dose in this study.
  • Participants have planning to undergo surgical treatment during this clinical trial. Tumor puncture or incisional lymph node biopsy is allowed.
  • Have received pembrolizumab or any other immune checkpoints inhibitors (PD-1, PD-L1, CTLA4, etc.) before randomization.
  • Participants have participated in a clinical study with another investigational medicinal product prior to randomization, and the interval between the current study and the previous study is too short: within 1 month prior to the first dose of the current study or within 5 half-lives of the previous investigational medicinal product (whichever is longer). Or planning to participate in a clinical study with another investigational medicinal product before completing all scheduled assessments in this clinical study.
  • Participants have participated in a device clinical study within 1 month prior to screening, or are participating in another surgical or device clinical study at the time of screening, or plan to participate in another surgical or device clinical study during this clinical study.
  • The investigator has a clear reason to believe that participation in this study would be detrimental to the participant.

Trial locations and contacts

69 sites in 4 countries.

69 sites in 4 countries

China42 sites

  • Beijing Chest Hospital, Capital Medical University

    Beijing, Beijing Municipality, 101149

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, 233000

  • Binzhou Medical University Hospital

    Binzhou, Shandong, 256603

  • Cangzhou Central Hospital

    Cangzhou, Hebei, 061012

  • The First Hospital of Jilin University

    Changchun, Jilin, 130000

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan, 410006

  • Xiangya Hospital of Central South University

    Changsha, Hunan, 410028

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610000

  • Sichuan Cancer Hospital

    Chengdu, Sichuan, 610041

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350000

  • Yuebei People's Hospital

    Guangdong, Shaoguan, 512000

  • Guangxi Medical University Cancer Center

    Guangxi, Nanning, 530221

  • The First Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230022

  • The First Affiliated Hospital of University of South China

    Hengyang, Hunan

  • Hunan Provincial Cancer Hospital

    Hunan, Changsha, 410031

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250012

  • Cancer Hospital of Shandong First Medical University

    Jinan, Shandong, 250117

  • Yunnan Cancer Hospital

    Kunming, Yunnan, 650118

  • The Second Hospital of Lanzhou University

    Lanzhou, Gansu, 730030

  • Linyi Cancer Hospital

    Linyi, Shandong, 276000

  • Jiangxi Cancer Hospital

    Nanchang, Jiangxi, 330001

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330200

  • ShangHai Pulmonary Hospital

    Shanghai, Shanghai Municipality, 200000

  • Shanghai Chest Hospital

    Shanghai, Shanghai Municipality, 200030

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

  • Zhongshan Hospital, Fudan University

    Shanghai, Shanghai Municipality, 200032

  • Liaoning Cancer Hospital and Institute

    Shenyang, Liaoning, 110042

  • Liaoning Cancer Hospital and Institute

    Shenyang, Liaoning

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050035

  • Shanxi Bethune Hospital

    Taiyuan, Shanxi, 030032

  • Taizhou Hospital of Zhejiang Province

    Taizhou, Zhejiang, 317000

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei, 430022

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei, 430071

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430079

  • The First Affiliated Hospital of Wannan Medical College

    Wuhu, Anhui, 241004

  • The First Affiliated Hospital of Xi'an Jiao Tong University

    Xi’an, Shanxi, 710061

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 361003

  • The First Affiliated Hospital of Xinxiang Medical University

    Xinxiang, Henan, 453100

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu, 221006

Other trials in China

United States12 sites

  • BRCR Global

    Deerfield Beach, Florida, 33326

  • Oncology Physicians Network (OPN) - Glendale

    Glendale, California, 91203

  • Oncology Consulatants (P1 Trials -Exigent Network)

    Houston, Texas, 77030

  • Oncology Physicians Network (OPN)- Los Alamitos

    Los Alamitos, California, 90720

  • HCA

    Los Angeles, California, 64132

  • Los Angeles Cancer Network

    Los Angeles, California, 92801

  • D&H National Research Center

    Margate, Florida, 33063

  • Ocala Oncology

    Ocala, Florida, 34474

  • American Oncology Network Vista Oncology Division

    Olympia, Washington, 98506

  • Mid Florida Hematology and oncology Center

    Orange City, Florida, 32763

  • Oncology Physicians Network (OPN) - San Bernardino

    San Bernardino, California, 91203

  • Northwest Medical Specialties PPLC (P1 Trials - Exigent Network )

    Tacoma, Washington, 98405

Other trials in United States

Turkey (Türkiye)8 sites

  • Adana City Training and Research Hospital

    Adana, 1370

  • Dr. Abdurrahman Yurtaslan Ankara Training and Research Hospital

    Ankara, 6200

  • Hacettepe University Oncology Hospital

    Ankara, 6230

  • Ankara University Hospital

    Ankara, 6590

  • Ankara Bilkent City Hospital Department of Medical Oncology

    Ankara, 6800

  • Gaziantep City Hospital

    Gaziantep, 27470

  • Yeditepe University Kosuyolu Hospital

    Istanbul, 34718

  • Izmir Economy University Medical Point Hospital

    Izmir, 35575

Other trials in Turkey (Türkiye)

Georgia7 sites

  • LTD High Technology Hospital Medcenter

    Batumi, 6000

  • JSC Vian

    Kutaisi, 4600

  • Israel- Georgian Medical Research Clinic Healthycore

    Tbilisi, 0112

  • High Technology Medical Center, University Clinic

    Tbilisi, 0144

  • St. Michael's Hospital LLC

    Tbilisi, 0159

  • TIM - Tbilisi Institute of Medicine LLC

    Tbilisi, 0160

  • Caucasus Medical Centre LLC

    Tbilisi, 0186

Other trials in Georgia

About this study

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

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).

Being tested
HLX17, US-sourced Keytruda®
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Melanoma, Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HLX17Drug

    Also called pembrolizumab

    Subjects will receive HLX17 (200 mg) on Day 1 of each 3-week cycle

  • US-sourced Keytruda®Drug

    Also called pembrolizumab

    Subjects will receive US-sourced Keytruda® (200 mg) on Day 1 of each 3-week cycle

Study groups in NCT07160335
Study groupRoleWhat they receive
HLX17ExperimentalSubjects will receive HLX17 (200 mg) on Day 1 of each 3-week cycle, until 12 months after the randomization (nearly 17 cycles) or investigator-assessed disease recurrence, death, initiation of new anti-tumor therapy, unacceptable drug toxicity, withdrawal of informed consent form, or study termination (whichever occurs first).
Receives: Drug: HLX17
US-sourced Keytruda®Active comparatorSubjects will receive US-sourced Keytruda® (200 mg) on Day 1 of each 3-week cycle, for a total of 8 cycles (24 weeks). After 8 cycles, all subjects in the US-sourced Keytruda® group will receive HLX17 200 mg on Day 1 of each 3-week cycle until 12 months after the randomization (nearly 17 cycles) or investigator-assessed disease recurrence, death, initiation of new anti-tumor therapy, unacceptable drug toxicity, withdrawal of informed consent form, or study termination (whichever occurs first).
Receives: Drug: HLX17; Drug: US-sourced Keytruda®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. AUC0-21d

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

    Measured: rom time 0 to 21 days after the 1st dose (3 weeks)

  2. AUCss

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

    Measured: from time 0 to 21 days after the 6th dose (18 weeks)

Secondary outcomes (11)

  1. maximum serum drug concentration (Cmax),

    Detailed Outcome Measure will be defined in the Statistical Analysis Plan

    Measured: up to 24 weeks

  2. trough serum drug concentration at steady state (Ctrough,ss)

    Detailed Outcome Measure will be defined in the Statistical Analysis Plan

    Measured: up to 24 weeks

  3. maximum serum drug concentration at steady state (Cmax,ss)

    Detailed Outcome Measure will be defined in the Statistical Analysis Plan

    Measured: up to 24 weeks

  4. trough serum drug concentration (Ctrough)

    Detailed Outcome Measure will be defined in the Statistical Analysis Plan

    Measured: up to 24 weeks

  5. DFS

    Defined as the time from randomization to tumor recurrence, the development of new tumor lesions, or death due to any reasons (whichever occur first).

    Measured: up to 12 months

  6. Adverse events

    Adverse events (AEs) Serious adverse events (SAEs) Adverse events of special interest (AESIs) (including immune-related adverse events and infusion-related reactions)

    Measured: From enrollment to the end of 90-day safety follow-up (up to 15 months)

  7. Number of participants with abnormal vital signs

    Detailed Outcome Measure will be defined in the Statistical Analysis Plan

    Measured: From enrollment to the end of 30-day safety follow-up (up to 13 months)

  8. Number of participants with abnormal physical examination findings

    Detailed Outcome Measure will be defined in the Statistical Analysis Plan

    Measured: From enrollment to the end of 30-day safety follow-up (up to 13 months)

  9. Number of participants with abnormal Laboratory tests results (hematology, serum chemistry, thyroid function, coagulation function, and myocardial markers)

    Detailed Outcome Measure will be defined in the Statistical Analysis Plan

    Measured: From enrollment to the end of 30-day safety follow-up (up to 13 months)

  10. Number of participants with abnormal 12-lead ECG readings

    Detailed Outcome Measure will be defined in the Statistical Analysis Plan

    Measured: From enrollment to the end of 30-day safety follow-up (up to 13 months)

  11. Immunogenicity endpoint

    Incidence of anti-drug antibody (ADA) and/or neutralizing antibody (NAb)

    Measured: up to 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2025
  2. Study start26 Sep 2025
  3. Primary completion30 Apr 2027 (estimated)
  4. Study completion27 Mar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
174 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07160335
Sponsor's protocol ID
HLX17-MRST001
Status last verified
Aug 2026
First submitted
22 Aug 2025
Last updated
20 Oct 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HLX17 and US-sourced Keytruda® in people with Non-small Cell Lung Cancer and Melanoma, run by Shanghai Henlius Biotech at 69 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 69 sites in China, United States, Turkey (Türkiye), Georgia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AUC0-21d (time frame: rom time 0 to 21 days after the 1st dose (3 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07160335.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.

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