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Monoclonal Antibodies

LVGN6051 + Pembrolizumab for Metastatic Cancer

Phase 1
Recruiting
Research Sponsored by Lyvgen Biopharma Holdings Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Men and women of childbearing potential must agree to take highly effective contraceptive methods
Patients infected with the HIV virus will be eligible if the disease is under control of effective therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights

Study Summary

This trial is studying a new drug, LVGN6051, to see if it is safe and effective when given alone or with another drug, pembrolizumab (MK-3475), in treating patients with solid tumors that have spread to other parts of the body.

Who is the study for?
Adults with advanced or metastatic cancer who have a life expectancy of at least 90 days and are in good organ function. They must not be on immunotherapy, have active autoimmune diseases, severe heart conditions, recent infections requiring IV drugs, lung disease needing steroids, or be pregnant/breastfeeding. HIV-positive patients can join if well-controlled.Check my eligibility
What is being tested?
The trial is testing LVGN6051 alone and combined with Pembrolizumab 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 people with advanced cancers.See study design
What are the potential side effects?
Potential side effects include reactions related to immune system activation such as inflammation in various organs, infusion-related reactions from the antibody treatment, and possibly other common drug-related adverse events.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I agree to use highly effective birth control methods.
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My HIV is under control with effective treatment.
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I am 18 years old or older.
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My bone marrow, liver, and kidneys are functioning well.
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My cancer is confirmed to be advanced and cannot be removed by surgery.
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I have recovered from side effects of my previous cancer treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety/Tolerability

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Activated partial thromboplastin time prolonged
5%
Intractable pain, back pain, hip pain
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Skin rash
2%
Thrombocytopenia
2%
Respiratory failure
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

1Treatment groups
Experimental Treatment
Group I: LVGN6051Experimental Treatment2 Interventions
The dose escalation phase includes 10 dose levels of LVGN6051, and the highest dose is up to 10mg/kg. 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.

Find a Location

Who is running the clinical trial?

Lyvgen Biopharma Holdings LimitedLead Sponsor
5 Previous Clinical Trials
594 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,868 Previous Clinical Trials
5,051,712 Total Patients Enrolled

Media Library

LVGN6051 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04130542 — Phase 1
Cancer Research Study Groups: LVGN6051
Cancer Clinical Trial 2023: LVGN6051 Highlights & Side Effects. Trial Name: NCT04130542 — Phase 1
LVGN6051 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04130542 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What have been the outcomes of patients taking LVGN6051?

"Limited data exists to assess the safety and efficacy of LVGN6051, so it has been given a score of 1 on Power's rating scale."

Answered by AI

Are there any available spots in this research trial for prospective participants?

"Affirmative. Clinicaltrials.gov indicates that this clinical trial, first posted on October 31st 2019, is still actively accepting applicants. The experiment requires 276 participants from a single medical centre."

Answered by AI

What is the scope of participants in this research endeavor?

"Affirmative. The information on clinicaltrials.gov suggests that this medical trial, which was initially posted October 31st 2019, is currently recruiting patients. A total of 276 people need to be enlisted from a single site."

Answered by AI
~28 spots leftby Oct 2024