CancerPhase 1NCT04694781
Study of LVGN6051 (CD137 Agonist Antibody) in Advanced or Metastatic Malignancy
A Phase 1 study testing LVGN6051 and Pembrolizumab in people with Cancer, run by Lyvgen Biopharma Holdings Limited at 2 sites in China.
Trial summary
The study of LVGN6051-201 is designed to use a bridging dose escalation to quickly 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 LVGN6051, both as a single agent (monotherapy) and in combination with a fixed dose 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?
- LVGN6051 and Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesChina
- Study dates
- 14 May 2021to 31 Oct 2023
- 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.
Who cannot join
- Receipt of CD137 and or PD-1 antibodies.
- Receipt of systemic anticancer therapy within 5 half-lives of the first dose of study treatment.
- Known active CNS metastasis and/or carcinomatous meningitis.
- Has received a live-virus vaccine within 30 days.
- Has had a Grade ≥ 3 allergic reaction to treatment with a monoclonal antibody.
- Abnormality of QT interval or syndrome.
Show all 15Show fewer
- Patients with history of Grade ≥ 3 immune-related AEs (irAEs) or irAE.
- Patients who are receiving an immunologically-based treatment for any reason.
- Active or chronic autoimmune disease that has required systemic treatment in the past 2 years or who are receiving systemic therapy for an autoimmune or inflammatory disease.
- Has a clinically significant cardiac condition, including unstable angina, acute myocardial infarction within 6 months.
- Has an active infection requiring intravenous (i.v.) anti-infectives within 14 days before the first dose of study treatment.
- Tested positive of HIV or HBV or HCV.
- Female patients who are pregnant or breastfeeding.
- Any evidence of severe or uncontrolled systemic disease.
- Has previously had a CAR-T therapy, or stem cell or bone marrow or solid organ transplant.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Cancer Hospital Chinese Academy of Medical Sciences
Beijing
Shanghai Chest Hospital
Shanghai
About this study
Official title: An Open Label, Phase 1 Trial of LVGN6051 as Single Agent and in Combination With Pembrolizumab in Advanced or Metastatic Malignancy
The study of LVGN6051-201 is designed to use a bridging dose escalation to quickly 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 LVGN6051, both as a single agent (monotherapy) and in combination with a fixed dose of anti-PD-1 antibody (Pembrolizumab) in the treatment of advanced or metastatic malignancy.
Read the detailed description
Based on the dose escalation results from the study of LVGN6051-101, a bridging dose escalation (3+3) is used in study of LVGN6051-201. The traditional 3 + 3 dose escalation algorithm to identify the MTD and/or RDE and RP2D of LVGN6051 as a single agent (monotherapy) and in combination with pembrolizumab. The first stage of the study is the single agent dose escalation and expansion phase (Part A). The second stage of the study is the combination dose escalation and expansion phase (Part B). Patients will be considered evaluable for safety and tolerability if they receive at least one dose of LVGN6051 or pembrolizumab 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
- LVGN6051, Pembrolizumab
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LVGN6051Drug
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.
PembrolizumabDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Monotherapy Dose Escalation | Experimental | LVGN6051 monotherapy dose escalation Receives: Drug: LVGN6051 |
| Monotherapy Dose Expansion | Experimental | LVGN6051 dose expansion cohorts Receives: Drug: LVGN6051 |
| Combination therapy dose escalation | Experimental | LVGN6051 in combination with anti-PD-1 antibody pembrolizumab dose escalation Receives: Drug: LVGN6051; Drug: Pembrolizumab |
| Combination therapy dose expansion | Experimental | LVGN6051 in combination with anti-PD-1 antibody pembrolizumab dose expansion cohorts Receives: Drug: LVGN6051; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-emergent adverse events (TEAEs) including determination of DLTs and serious AEs (SAEs)
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
MTD or RDE or RP2D
maximal tolerated dose, recommended dose for expansion or recommended phase 2 dose
Measured: up to 24 months
Secondary outcomes (5)
DCR
DCR will be documented as the proportion of patients with best overall response of CR, PR, or stable disease (SD). DCR per RECIST v1.1, iRECIST, and Cheson/Lugano criteria.
Measured: up to 24 months
PK parameter AUC
Area under the serum concentration versus time curve (AUC) will be determined.
Measured: up to 24 months
PK parameter Cmax
Peak Plasma Concentration (Cmax) will be summarized.
Measured: up to 24 months
PK parameter t1/2
Serum concentration half-life t1/2 will be summarized.
Measured: up to 24 months
ADA to LVGN6051
The presence of ADA directed against LVGN6051 will be determined.
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 posted5 Jan 2021
- Study start14 May 2021
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lyvgen Biopharma Holdings Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xin Luo, Study director, Lyvgen Biopharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04694781
- Sponsor's protocol ID
- LVGN6051-201
- Status last verified
- Mar 2024
- First submitted
- 16 Dec 2020
- Last updated
- 19 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Phase 1 Trial of LVGN6051 as Single Agent and in Combination With Pembrolizumab in Advanced or Metastatic Malignancy
- ClinicalTrials.gov ID
- NCT04694781
- Acronym / sponsor ID
- LVGN6051-201
- Conditions
- Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Lyvgen Biopharma Holdings LimitedIndustry (pharma, biotech, devices)
- Study start
- 14 May 2021 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 5 Jan 2021 (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.
The study of LVGN6051-201 is designed to use a bridging dose escalation to quickly 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 LVGN6051, both as a single agent (monotherapy) and in combination with a fixed dose of anti-PD-1 antibody (Pembrolizumab) in the treatment of advanced or metastatic malignancy.
Detailed description
Based on the dose escalation results from the study of LVGN6051-101, a bridging dose escalation (3+3) is used in study of LVGN6051-201. The traditional 3 + 3 dose escalation algorithm to identify the MTD and/or RDE and RP2D of LVGN6051 as a single agent (monotherapy) and in combination with pembrolizumab. The first stage of the study is the single agent dose escalation and expansion phase (Part A). The second stage of the study is the combination dose escalation and expansion phase (Part B). Patients will be considered evaluable for safety and tolerability if they receive at least one dose of LVGN6051 or pembrolizumab 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Monotherapy Dose Escalation | Experimental | Drug: LVGN6051LVGN6051 monotherapy dose escalation |
| Monotherapy Dose Expansion | Experimental | Drug: LVGN6051LVGN6051 dose expansion cohorts |
| Combination therapy dose escalation | Experimental | Drug: LVGN6051, Drug: PembrolizumabLVGN6051 in combination with anti-PD-1 antibody pembrolizumab dose escalation |
| Combination therapy dose expansion | Experimental | Drug: LVGN6051, Drug: PembrolizumabLVGN6051 in combination with anti-PD-1 antibody pembrolizumab dose expansion cohorts |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 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 (15 listed)
- Receipt of CD137 and or PD-1 antibodies.
- Receipt of systemic anticancer therapy within 5 half-lives of the first dose of study treatment.
- Known active CNS metastasis and/or carcinomatous meningitis.
- Has received a live-virus vaccine within 30 days.
- Has had a 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 |
|---|---|---|
| LVGN6051Route 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. | Drug | Combination therapy dose escalation, Combination therapy dose expansion, Monotherapy Dose Escalation, Monotherapy Dose Expansion |
| PembrolizumabRoute 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. | Drug | Combination therapy dose escalation, Combination therapy dose expansion |
Primary outcome
Treatment-emergent adverse events (TEAEs) including determination of DLTs and serious AEs (SAEs)
Time frame: up to 24 months
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.
MTD or RDE or RP2D
Time frame: up to 24 months
maximal tolerated dose, recommended dose for expansion or recommended phase 2 dose
5 secondary outcomes
DCR
Time frame: up to 24 months
PK parameter AUC
Time frame: up to 24 months
PK parameter Cmax
Time frame: up to 24 months
PK parameter t1/2
Time frame: up to 24 months
ADA to LVGN6051
Time frame: up to 24 months
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 Apr 2024.
- Individual participant dataSharing planned: Undecided
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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.
Xin Luo study director
Lyvgen Biopharma
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LVGN6051 and Pembrolizumab in people with Cancer, run by Lyvgen Biopharma Holdings Limited at 2 sites in China.
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 7 inclusion and 15 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 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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) including determination of DLTs and serious AEs (SAEs) (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 Apr 2024.