Your session is about to expire
← Back to Search
Monoclonal Antibodies
LVGN7409 for Advanced or 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
Males or females aged ≥ 18 years.
Patients must have a histologically or cytologically confirmed metastatic or unresectable malignancy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
Study Summary
This trial is testing a new drug, LVGN7409, to see what dose is safe for people and how well it works against cancer when used alone or with other drugs.
Who is the study for?
Adults with advanced or metastatic cancer who have recovered from previous treatments, have good organ function, and are not pregnant can join. They must agree to use effective birth control. People with heart issues, severe immune-related side effects from past therapies, recent strokes, organ transplants, live vaccines within a month, ongoing immunotherapy for other conditions or specific allergies cannot participate.Check my eligibility
What is being tested?
The trial is testing LVGN7409 alone and in combination with an anti-PD-1 antibody and/or CD137 agonist 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 patients with advanced cancers.See study design
What are the potential side effects?
Since this is a first-in-human study for LVGN7409, detailed side effects aren't listed but may include typical reactions seen with monoclonal antibodies like infusion reactions and immune system related adverse events.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
My cancer is confirmed to be advanced and cannot be removed by surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
RP2D of LVGN7409 as monotherapy
Treatment-emergent adverse events (TEAEs)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Monotherapy dose escalationExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LVGN7409
2021
Completed Phase 1
~40
Find a Location
Who is running the clinical trial?
Lyvgen Biopharma Holdings LimitedLead Sponsor
5 Previous Clinical Trials
744 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not received a live-virus vaccine in the last 30 days.I do not have uncontrolled fluid buildup in my chest, heart, or abdomen.I have an autoimmune disease.I have had severe immune-related side effects from treatment.My blood, liver, and kidney tests are within normal ranges.I am 18 years old or older.I am not pregnant or breastfeeding.I have HIV but it is well-managed with medication.My cancer is confirmed to be advanced and cannot be removed by surgery.I am currently receiving treatment that involves boosting my immune system.I agree to use effective birth control methods.I have not had a stroke in the past 6 months.I have recently had cancer treatment with drugs or radiation.I have a heart condition affecting my heart's rhythm.I had a severe reaction to previous immune therapy that required stopping the treatment.I have had a transplant of tissue, bone marrow, or an organ.I have recovered from side effects of my previous cancer treatments.I have previously been treated with anti-CD40 therapy.I have had a severe allergic reaction to a monoclonal antibody treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Monotherapy dose escalation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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 findings of LVGN7409's safety tests?
"The safety of LVGN7409 is estimated to be a 1, as this trial is only in the initial phase. This means that there are limited datasets demonstrating both efficacy and safety for this medication."
Answered by AI
How many individuals may partake in this clinical trail?
"Affirmative, the information on clinicaltrials.gov reveals that this study is actively enrolling patients at present. Originally posted on December 11th 2020 and last updated on April 4th 2022, it seeks to recruit a total of 126 individuals from one medical centre."
Answered by AI
Is enrollment for this experiment still available to prospective participants?
"Affirmative. According to clinicaltrials.gov, this medical experiment is actively seeking participants. This trial was first announced on December 11th 2020 and last revised on April 4th 2022. 126 volunteers are required from a single site for the study's completion."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger