Phase 1 Trial of LVGN6051 as Single Agent and in Combination With Keytruda (MK-3475-A31/KEYNOTE-A31) in Advanced or Metastatic Malignancy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04130542|
Recruitment Status : Recruiting
First Posted : October 17, 2019
Last Update Posted : February 23, 2023
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LVGN6051 is a humanized monoclonal antibody that specifically binds to CD137, and acts as an agonist against CD137.
This first in human study of LVGN6051 is designed to establish the maximum tolerated dose (MTD) and/or the recommended dose for expansion (RDE) as well as the recommended Phase 2 dose(s) (RP2D) of LVGN6051, both as a single agent (monotherapy) and in combination with a fixed dose of anti-PD-1 antibody (Pembrolizumab/MK-3475) in the treatment of advanced or metastatic malignancy.
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Biological: LVGN6051||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||276 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label, First in Human (FIH), Phase 1 Trial of LVGN6051 as Single Agent and in Combination With Pembrolizumab (MK-3475-A31/KEYNOTE-A31) in Advanced or Metastatic Malignancy|
|Actual Study Start Date :||October 31, 2019|
|Estimated Primary Completion Date :||October 2023|
|Estimated Study Completion Date :||March 2024|
The dose escalation phase includes 10 dose levels of LVGN6051, and the highest dose is up to 10mg/kg. Route of administration is IV infusion, and the frequency of administration is once every 3 weeks (Q3W). one cycle is 3 weeks, and treatment can be up to 35 cycles if patients receive benefits.
IV infusion once every 3 weeks (Q3W).
- Safety/Tolerability [ Time Frame: up to 24 months ]mEvaluate the safety and tolerability and determine the Maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) and recommended Phase 2 dose(s) (RP2D) of LVGN6051 administered as a single agent (monotherapy) and in combination with pembrolizumab, in adult patients with advanced malignancy.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Males or females aged ≥ 18 years.
- Ability to understand and willingness to sign a written informed consent document.
- Patients must have a histologically or cytologically confirmed metastatic or unresectable malignancy.
- Estimated life expectancy, in the judgment of the Investigator, of at least 90 days.
- Adequate bone marrow, liver, and renal functions.
- Men and women of childbearing potential must agree to take highly effective contraceptive methods.
- Patients should recover from all reversible AEs of previous anticancer therapies to baseline.
- Patients infected with the HIV virus will be eligible if the disease is under control of effective therapy.
- Receipt of systemic anticancer therapy including investigational agents or devices within 5 half-lives of the first dose of study treatment.
- Previous radiotherapy within 14 days of the first dose of study treatment.
- Known active CNS metastasis and/or carcinomatous meningitis.
- Has received a live-virus vaccine within 30 days.
- Has had a Grade ≥ 3 allergic reaction to treatment with a monoclonal antibody.
- Abnormality of QT interval or syndrome.
- Patients with history of Grade ≥ 3 immune-related AEs (irAEs) or irAE.
- Patients who are receiving an immunologically-based treatment for any reason.
- Treatment with systemic immune-stimulatory agents within 4 weeks prior to the first dose of study drug.
- Active or chronic autoimmune disease that has required systemic treatment in the past 2 years or who are receiving systemic therapy for an autoimmune or inflammatory disease.
- Has a clinically significant cardiac condition, including unstable angina, acute myocardial infarction within 6 months.
- Has an active infection requiring intravenous (i.v.) anti-infectives within 14 days before the first dose of study treatment.
- Current evidence or history of interstitial lung disease or active, noninfectious pneumonitis requiring treatment such as oral or intravenous glucocorticoids to assist with management.
- Female patients who are pregnant or breastfeeding.
- Any evidence of severe or uncontrolled systemic disease.
- Any other disease or clinically significant abnormality in laboratory parameters.
- Has previously had a stem cell or bone marrow or solid organ transplant.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04130542
|Contact: Lynn Jiang, PhDemail@example.com|
|United States, California|
|University of California Irvine Health||Recruiting|
|Orange, California, United States, 92868|
|Contact: Shikha Sanjiv Parikh, PharmD 714-456-5324 firstname.lastname@example.org|
|UCSF Helen Diller Family Comprehensive Cancer Center||Recruiting|
|San Francisco, California, United States, 94115|
|Contact: Marjan Rajabi 415-353-9682 email@example.com|
|United States, Indiana|
|Verdi Oncology Research||Recruiting|
|Lafayette, Indiana, United States, 47905|
|Contact: Mariela Abad, CCRC 765-446-5111 firstname.lastname@example.org|
|United States, Maryland|
|The Johns Hopkins University||Recruiting|
|Baltimore, Maryland, United States, 21205|
|Contact: Juan Pablo Gómez, MPH 410-502-5061 email@example.com|
|United States, Nebraska|
|Nebraska Cancer Specialist||Recruiting|
|Omaha, Nebraska, United States, 68130|
|Contact: Josh Settlemire, MSN 531-329-3651 firstname.lastname@example.org|
|United States, New York|
|NYU Langone Health||Recruiting|
|New York, New York, United States, 10016|
|Contact: Amy Ciriaco 212-731-5654 Amy.Ciriaco@nyulangone.org|
|United States, Texas|
|MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030-3722|
|Contact: Lynda Nelson, MA 713-794-3601 email@example.com|
|Responsible Party:||Lyvgen Biopharma Holdings Limited|
|Other Study ID Numbers:||
KEYNOTE-A31 ( Other Identifier: Merck Sharp & Dohme Corp. )
|First Posted:||October 17, 2019 Key Record Dates|
|Last Update Posted:||February 23, 2023|
|Last Verified:||January 2023|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|