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126 Participants Needed

LVGN7409 for Advanced or Metastatic Cancer

Overseen ByLynn Jiang, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Lyvgen Biopharma Holdings Limited

Must not be taking: Immunotherapy, Live-virus vaccines

Disqualifiers: Autoimmune disease, Cardiac condition, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are receiving an immunologically based treatment, you may not be eligible to participate.

What data supports the effectiveness of the drug LVGN7409, a CD40 agonist, for advanced or metastatic cancer?

Research shows that CD40 agonists, like LVGN7409, can activate the immune system to fight cancer by stimulating certain immune cells. They have shown anti-tumor effects in various cancer models, especially when combined with other treatments, suggesting potential effectiveness in treating advanced cancers.¹ ² ³ ⁴ ⁵

What is known about the safety of CD40 agonists like LVGN7409 in humans?

CD40 agonists, including LVGN7409, have shown some anti-tumor activity with manageable side effects in early clinical trials. Reported side effects include temporary cytokine release (immune system reaction), liver toxicity, and blood clotting events, but these have generally been controllable.¹ ³ ⁶ ⁷ ⁸

How is the drug LVGN7409 different from other cancer treatments?

LVGN7409 is unique because it targets CD40, a protein on immune cells, to activate the body's immune response against cancer. This approach can enhance the effects of other treatments, like checkpoint inhibitors, by boosting the immune system's ability to fight tumors.² ³ ⁴ ⁵ ⁶

Eligibility Criteria

Adults with advanced or metastatic cancer who have recovered from previous treatments, have good organ function, and are not pregnant can join. They must agree to use effective birth control. People with heart issues, severe immune-related side effects from past therapies, recent strokes, organ transplants, live vaccines within a month, ongoing immunotherapy for other conditions or specific allergies cannot participate.

Inclusion Criteria

Ability to understand and willingness to sign a written informed consent document.

My blood, liver, and kidney tests are within normal ranges.

I have HIV but it is well-managed with medication.

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Exclusion Criteria

I have not received a live-virus vaccine in the last 30 days.

I do not have uncontrolled fluid buildup in my chest, heart, or abdomen.

I have an autoimmune disease.

See 10 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive LVGN7409 as monotherapy in an accelerated dose escalation to determine the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE)

up to 24 months

Every 3 weeks (Q3W)

Dose Expansion

Participants receive LVGN7409 in combination with anti-PD-1 antibody and/or CD137 agonist to further evaluate safety and efficacy

up to 24 months

Every 3 weeks (Q3W)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

LVGN7409

Trial Overview The trial is testing LVGN7409 alone and in combination with an anti-PD-1 antibody and/or CD137 agonist to find the safest dose for future studies. It aims to determine how much of these drugs can be given without causing serious side effects in patients with advanced cancers.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Monotherapy dose escalationExperimental Treatment1 Intervention

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.

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Who Is Running the Clinical Trial?

Lyvgen Biopharma Holdings Limited

Lead Sponsor

Trials

Recruited

930+

Findings from Research

Agonistic CD40 monoclonal antibodies (mAb) have shown promise in activating the immune system to generate anticancer responses, potentially offering a new therapeutic option that works differently from traditional immune checkpoint inhibitors like anti-CTLA-4 or anti-PD-1.

Initial clinical trials indicate that agonistic CD40 mAb can produce effective antitumor responses without significant toxicity, suggesting a safe profile for use in cancer treatment, although further research is needed to optimize dosing and administration strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Agonistic CD40 antibodies and cancer therapy.Vonderheide, RH., Glennie, MJ.[2022]

CD40 agonists have shown potential in cancer immunotherapy, demonstrating moderate antitumor effects in some tumors, based on early clinical trials.

The adverse events associated with CD40 agonists, such as cytokine release and hepatotoxicity, have been mostly transient and manageable, suggesting a favorable safety profile for further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics and clinical trial results of agonistic anti-CD40 antibodies in the treatment of malignancies.Li, DK., Wang, W.[2020]