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Trial record 3 of 5 for:    LVGN6051
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Study of LVGN6051 (CD137 Agonist Antibody) in Advanced or Metastatic Malignancy

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ClinicalTrials.gov Identifier: NCT04694781
Recruitment Status : Recruiting
First Posted : January 5, 2021
Last Update Posted : March 10, 2023
Sponsor:
Information provided by (Responsible Party):
Lyvgen Biopharma Holdings Limited

Study Description
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Brief 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 anti-PD-1 antibody (Pembrolizumab) in the treatment of advanced or metastatic malignancy.

Condition or disease Intervention/treatment Phase
Cancer Drug: LVGN6051 Drug: Pembrolizumab Phase 1

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Phase 1 Trial of LVGN6051 as Single Agent and in Combination With Pembrolizumab in Advanced or Metastatic Malignancy
Actual Study Start Date : May 14, 2021
Estimated Primary Completion Date : April 11, 2023
Estimated Study Completion Date : July 11, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Monotherapy Dose Escalation
LVGN6051 monotherapy dose escalation
 Drug: LVGN6051
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.
Experimental: Monotherapy Dose Expansion
LVGN6051 dose expansion cohorts
 Drug: LVGN6051
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.
Experimental: Combination therapy dose escalation
LVGN6051 in combination with anti-PD-1 antibody pembrolizumab dose escalation
 Drug: LVGN6051
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.

Drug: Pembrolizumab
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.
Experimental: Combination therapy dose expansion
LVGN6051 in combination with anti-PD-1 antibody pembrolizumab dose expansion cohorts
 Drug: LVGN6051
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.

Drug: Pembrolizumab
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. MTD or RDE or RP2D [ Time Frame: up to 24 months ]
    maximal tolerated dose, recommended dose for expansion or recommended phase 2 dose


Secondary Outcome Measures :
  1. DCR [ Time Frame: up to 24 months ]
    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.

  2. PK parameter AUC [ Time Frame: up to 24 months ]
    Area under the serum concentration versus time curve (AUC) will be determined.

  3. PK parameter Cmax [ Time Frame: up to 24 months ]
    Peak Plasma Concentration (Cmax) will be summarized.

  4. PK parameter t1/2 [ Time Frame: up to 24 months ]
    Serum concentration half-life t1/2 will be summarized.

  5. ADA to LVGN6051 [ Time Frame: up to 24 months ]
    The presence of ADA directed against LVGN6051 will be determined.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Exclusion Criteria:

  • 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.
  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04694781


Contacts
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Contact: lynn Jiang, PhD 484-686-9652 lynn.jiang@lyvgen.com

Locations
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China
Cancer Hospital Chinese Academy of Medical Sciences Active, not recruiting
Beijing, China
Shanghai Chest Hospital Recruiting
Shanghai, China
Contact: Zhen Zhou    8613611979382    jenniferzhou1116@gmail.com   
Sponsors and Collaborators
Lyvgen Biopharma Holdings Limited
Investigators
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Study Director: Xin Luo Lyvgen Biopharma
More Information
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Responsible Party: Lyvgen Biopharma Holdings Limited
ClinicalTrials.gov Identifier: NCT04694781    
Other Study ID Numbers: LVGN6051-201
First Posted: January 5, 2021    Key Record Dates
Last Update Posted: March 10, 2023
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Neoplasms
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents