- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04635995
Phase 1 Trial of LVGN7409 (CD40 Agonist Antibody) as Single Agent and Combination Therapies in Advanced or Metastatic Malignancy
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
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.
Study Overview
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Lynn Jiang, PhD
- Phone Number: 1-484-686-9652
- Email: lynn.jiang@lyvgen.com
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030-3722
- Recruiting
- MD Anderson Cancer Center
-
Contact:
- Yi-Hsin Hsu, PhD
- Phone Number: 713-794-3601
- Email: YHsu1@mdanderson.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
up to 24 months
|
RP2D of LVGN7409 as monotherapy
Time Frame: up to 24 months
|
determination of MTD, RDE and/or RP2D of LVGN7409 as monotherapy
|
up to 24 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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