CancerPhase 1NCT04635995
Phase 1 Trial of LVGN7409 (CD40 Agonist Antibody) as Single Agent and Combination Therapies in Advanced or Metastatic Malignancy
A Phase 1 study testing LVGN7409 in people with Cancer, run by Lyvgen Biopharma Holdings Limited at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- LVGN7409
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Dec 2020to 31 Dec 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
MD Anderson Cancer Center
Houston, Texas, 77030-3722
About this study
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
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.
Read the detailed description
This is an open-label, non-randomized, two-stage, FIH Phase 1 study, utilizing an accelerated dose escalation followed by a traditional 3 + 3 dose escalation algorithm to identify the MTD and/or RDE and RP2D of LVGN7409 as a single agent (monotherapy) and in combination with anti-PD-1 antibody and/or CD137 agonist. The first stage of the study is the dose escalation phase (i.e., Phase 1a). The second stage of the study is the dose expansion phase (i.e., Phase 1b). During the study, dose interruption(s) and/or delay(s) may be implemented based on toxicity. Dose modifications are not permitted. Intra-patient dose escalations will be allowed for the early dose cohorts (single-patient dose groups) in Phase 1a Part 1. Patients will be considered evaluable for safety and tolerability if they receive at least one dose of LVGN7409 or anti-PD-1 antibody and/or CD137 agonist at the specified cohort dose. Patients in all parts of the trial will remain on therapy until confirmed disease progression or for 2 years, whichever occurs first. However, patients who are clinically unstable will discontinue following the initial assessment of disease progression.
- Conditions
- Cancer
- Being tested
- LVGN7409
- Keywords
- Lyvgen, CD40
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LVGN7409Biological
IV infusion once every 3 weeks (Q3W).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: LVGN7409 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 24 months
RP2D of LVGN7409 as monotherapy
determination of MTD, RDE and/or RP2D of LVGN7409 as monotherapy
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start11 Dec 2020
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lyvgen Biopharma Holdings Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04635995
- Sponsor's protocol ID
- LVGN7409-101
- Status last verified
- May 2026
- First submitted
- 9 Nov 2020
- Last updated
- 19 May 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04635995
- Acronym / sponsor ID
- LVGN7409-101
- Conditions
- Cancer
- Keywords
- Lyvgen, CD40
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Lyvgen Biopharma Holdings LimitedIndustry (pharma, biotech, devices)
- Study start
- 11 Dec 2020 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 19 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is an open-label, non-randomized, two-stage, FIH Phase 1 study, utilizing an accelerated dose escalation followed by a traditional 3 + 3 dose escalation algorithm to identify the MTD and/or RDE and RP2D of LVGN7409 as a single agent (monotherapy) and in combination with anti-PD-1 antibody and/or CD137 agonist. The first stage of the study is the dose escalation phase (i.e., Phase 1a). The second stage of the study is the dose expansion phase (i.e., Phase 1b). During the study, dose interruption(s) and/or delay(s) may be implemented based on toxicity. Dose modifications are not permitted. Intra-patient dose escalations will be allowed for the early dose cohorts (single-patient dose groups) in Phase 1a Part 1. Patients will be considered evaluable for safety and tolerability if they receive at least one dose of LVGN7409 or anti-PD-1 antibody and/or CD137 agonist at the specified cohort dose. Patients in all parts of the trial will remain on therapy until confirmed disease progression or for 2 years, whichever occurs first. However, patients who are clinically unstable will discontinue following the initial assessment of disease progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Monotherapy dose escalation | Experimental | Biological: LVGN7409The 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LVGN7409IV infusion once every 3 weeks (Q3W). | Biological | Monotherapy dose escalation |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LVGN7409 in people with Cancer, run by Lyvgen Biopharma Holdings Limited at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment-emergent adverse events (TEAEs) (time frame: up to 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.