Phase 1 Trial of LVGN7409 (CD40 Agonist Antibody) as Single Agent and Combination Therapies in Advanced or Metastatic Malignancy

NCT04635995 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: LVGN7409-101
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer

Keywords

Lyvgen; CD40

Outcome Measures

Primary Outcomes (2)

• Treatment-emergent adverse events (TEAEs)

  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

  determination of MTD, RDE and/or RP2D of LVGN7409 as monotherapy

  up to 24 months

Study Arms (1)

Monotherapy dose escalation

EXPERIMENTAL

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.

Biological: LVGN7409

Interventions

LVGN7409 BIOLOGICAL

IV infusion once every 3 weeks (Q3W).

Monotherapy dose escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lyvgen Biopharma Holdings Limited: lead

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030-3722, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2020
• First Posted: November 19, 2020
• Study Start: December 11, 2020
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: October 31, 2024

Record last verified: 2024-10

Locations

US (1)