BridgeMD
Tests treatment safety and results for Non-small Cell Lung Cancer
Official title A Phase I Clinical Study to Evaluate the PK Profile, Efficacy, Safety and Immunogenicity of HLX17 vs. Keytruda® in Multiple Resected Solid Tumors
ClinicalTrials.gov ID: NCT07160335
What this study is testing
What is HLX17?
HLX17 is an investigational medicine, being studied as a potential treatment for non-small cell lung cancer.
Also referred to as pembrolizumab.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- Participants must have signed and dated an Institutional Review Board/Independent Ethics Committee (IRB/IEC) approved written informed consent form...
- 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
You likely can't join if
- 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...
- 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.
See the full eligibility criteria
Who can 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
- 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...
- 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...
- 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...
What rules you out
- 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...
- 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.
- 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...
- 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...
- 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...
- 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 how well it works dosage) or other immunosuppressive drugs within 14 days prior to the first dose or during the study. However, participants are allowed...
- 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...
- 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...
- The investigator has a clear reason to believe that participation in this study would be detrimental to the participant.
The study team makes the final eligibility decision.
Where it's taking place
- Glendale, California, United States
- Los Alamitos, California, United States
- Los Angeles, California, United States
- San Bernardino, California, United States
- Deerfield Beach, Florida, United States
- Margate, Florida, United States
- Ocala, Florida, United States
- Orange City, Florida, United States
- Houston, Texas, United States
- Olympia, Washington, United States
- Tacoma, Washington, United States
- Hefei, Anhui, China
- Wuhu, Anhui, China
- Beijing, Beijing Municipality, China
- Hunan, Changsha, China
- Fuzhou, Fujian, China
- Xiamen, Fujian, China
- Lanzhou, Gansu, China
- Cangzhou, Hebei, China
- Shijiazhuang, Hebei, China
+ 30 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Glendale, California, United States; Los Alamitos, California, United States; Los Angeles, California, United States; San Bernardino, California, United States; Deerfield Beach, Florida, United States; Margate, Florida, United States and 44 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.