Phase 1 Trial of LVGN7409 (CD40 Agonist Antibody) as Single Agent and Combination Therapies in Advanced or Metastatic Malignancy
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|ClinicalTrials.gov Identifier: NCT04635995|
Recruitment Status : Recruiting
First Posted : November 19, 2020
Last Update Posted : March 8, 2023
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LVGN7409 is a humanized monoclonal antibody that specifically binds to CD40, and acts as an agonist against CD40.
This first in human study of LVGN7409 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 LVGN7409, both as a single agent (monotherapy) and in combination with a fixed dose of anti-PD-1 antibody and/or CD137 agonist in the treatment of advanced or metastatic malignancy.
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Biological: LVGN7409||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||126 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label, First in Human (FIH), Phase 1a/1b Trial of LVGN7409 (CD40 Agonist Antibody) as a Single Agent, in Combination With LVGN3616 (Anti-PD-1 Antibody), and in Combination With LVGN3616 and LVGN6051 (CD137 Agonist Antibody) in Patients With Locally Advanced, Relapsed, Refractory, or Metastatic Malignancy|
|Actual Study Start Date :||December 11, 2020|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||December 2023|
Experimental: Monotherapy dose escalation
The monotherapy dose escalation phase includes 8 dose levels of LVGN7409. 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).
- Treatment-emergent adverse events (TEAEs) [ Time Frame: up to 24 months ]determination of DLTs and serious AEs (SAEs) of LVGN7409 as monotherapy. Adverse events will be assessed, and severity will be assigned by using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
- RP2D of LVGN7409 as monotherapy [ Time Frame: up to 24 months ]determination of MTD, RDE and/or RP2D of LVGN7409 as monotherapy
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|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.
- Prior therapy with anti-CD40 therapy.
- Receipt of systemic anticancer therapy or radiotherapy within certain period of time.
- Prior exposure to immune-therapeutics experienced Grade ≥ 3 drug-related toxicity, or a toxicity requiring discontinuation.
- Received a live-virus vaccine within 30 days of the first dose of study drug.
- Grade ≥ 3 allergic reaction to treatment with a monoclonal antibody.
- History of Grade ≥ 3 immune-related AEs (irAEs).
- Prolonged QT syndrome, or clinically significant cardiac condition.
- Receiving an immunologically based treatment for any reason.
- History or current active or chronic autoimmune disease.
- Uncontrolled pleural effusion, pericardial effusion, or recurrent ascites drainage.
- Female patients who are pregnant or breastfeeding.
- History of hemorrhagic or ischemic stroke within the last 6 months.
- Previously received an allogeneic tissue/organ transplant, stem cell or bone marrow transplant 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): NCT04635995
|Contact: Lynn Jiang, PhDemail@example.com|
|United States, Texas|
|MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030-3722|
|Contact: Yi-Hsin Hsu, PhD 713-794-3601 YHsu1@mdanderson.org|
|Responsible Party:||Lyvgen Biopharma Holdings Limited|
|Other Study ID Numbers:||
|First Posted:||November 19, 2020 Key Record Dates|
|Last Update Posted:||March 8, 2023|
|Last Verified:||April 2022|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|