Study of LVGN6051 (CD137 Agonist Antibody) in Advanced or Metastatic Malignancy

NCT04694781 | Completed Phase 1

• 1 other identifier: LVGN6051-201
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (2)

• 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.

  up to 24 months

• MTD or RDE or RP2D

  maximal tolerated dose, recommended dose for expansion or recommended phase 2 dose

  up to 24 months

Secondary Outcomes (5)

• DCR

  up to 24 months

• PK parameter AUC

  up to 24 months

• PK parameter Cmax

  up to 24 months

• PK parameter t1/2

  up to 24 months

• ADA to LVGN6051

  up to 24 months

Study Arms (4)

Monotherapy Dose Escalation

EXPERIMENTAL

LVGN6051 monotherapy dose escalation

Drug: LVGN6051

Monotherapy Dose Expansion

EXPERIMENTAL

LVGN6051 dose expansion cohorts

Drug: LVGN6051

Combination therapy dose escalation

EXPERIMENTAL

LVGN6051 in combination with anti-PD-1 antibody pembrolizumab dose escalation

Drug: LVGN6051; Drug: Pembrolizumab

Combination therapy dose expansion

EXPERIMENTAL

LVGN6051 in combination with anti-PD-1 antibody pembrolizumab dose expansion cohorts

Drug: LVGN6051; Drug: Pembrolizumab

Interventions

LVGN6051 DRUG

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.

Combination therapy dose escalation; Combination therapy dose expansion; Monotherapy Dose Escalation; Monotherapy Dose Expansion

Pembrolizumab DRUG

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.

Combination therapy dose escalation; Combination therapy dose expansion

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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lyvgen Biopharma Holdings Limited: lead

Study Sites (2)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, China

Location

Shanghai Chest Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Neoplasms

Interventions

pembrolizumab

Study Officials

• Xin Luo

  Lyvgen Biopharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2020
• First Posted: January 5, 2021
• Study Start: May 14, 2021
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: April 19, 2024

Record last verified: 2024-03

Locations

CN (2)