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Monoclonal Antibodies

LVGN3616 + LVGN6051 Combinations for Advanced Cancers

Phase 1
Recruiting
Led By Siqing Fu
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female aged ≥18 years.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights

Study Summary

This trial is testing whether four different combinations of drugs can shrink tumors in seven different types of cancer. The drugs will be provided at no cost to patients.

Who is the study for?
Adults (≥18 years) with certain metastatic solid tumors, measurable disease, good performance status (ECOG 0-1), and adequate organ function can join. They must not have unresolved significant side effects from past treatments or be on conflicting trials or medications. Pregnant women, those with active severe infections like HIV/Hepatitis B/C, recent live vaccines, autoimmune diseases needing treatment in the last 2 years, or a history of severe reactions to monoclonal antibody therapy are excluded.Check my eligibility
What is being tested?
The trial is testing combinations of new drugs LVGN3616 and LVGN6051 with/without LVGN7409 alongside Nab-Paclitaxel or Bevacizumab and Cyclophosphamide for their effectiveness against selected metastatic cancers. It's an early-phase study to see how well these drug combos work.See study design
What are the potential side effects?
Potential side effects may include typical chemotherapy-related issues such as nausea, fatigue, hair loss from Nab-Paclitaxel; high blood pressure and bleeding risks from Bevacizumab; immune system complications due to the investigational drugs which could lead to inflammation in various organs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I am fully active or can carry out light work.
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My cancer has spread, and its genetic makeup was tested in a certified lab.
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My kidney function, measured by creatinine levels or clearance, is within the required range.
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I am not pregnant and am using effective birth control.
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I am 18 years old or older.
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I can carry out all my usual activities without help.
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My cancer has spread, lacks standard treatment options, and has been tested in a certified lab.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To establish the maximum tolerated dose (MTD)/recommended.

Trial Design

4Treatment groups
Experimental Treatment
Group I: Regimen D: LVGN3616 + LVGN6051 + LVGN7409 + Bevacizumab + CyclophosphamideExperimental Treatment4 Interventions
given in combination with other drugs to patients with cancers that are advanced, relapsed (have come back), refractory (have not responded to treatment), or metastatic (have spread).
Group II: Regimen C: LVGN3616 + LVGN6051 + LVGN7409 + Nab-PaclitaxelExperimental Treatment4 Interventions
given in combination with other drugs to patients with cancers that are advanced, relapsed (have come back), refractory (have not responded to treatment), or metastatic (have spread).
Group III: Regimen B: LVGN3616 + LVGN6051 + Bevacizumab + CyclophosphamideExperimental Treatment4 Interventions
given in combination with other drugs to patients with cancers that are advanced, relapsed (have come back), refractory (have not responded to treatment), or metastatic (have spread).
Group IV: Regimen A: LVGN3616 + LVGN6051 + Nab-PaclitaxelExperimental Treatment4 Interventions
given in combination with other drugs to patients with cancers that are advanced, relapsed (have come back), refractory (have not responded to treatment), or metastatic (have spread).

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,962 Previous Clinical Trials
1,803,013 Total Patients Enrolled
Lyvgen Biopharma Holdings LimitedIndustry Sponsor
5 Previous Clinical Trials
518 Total Patients Enrolled
Siqing FuPrincipal InvestigatorM.D. Anderson Cancer Center
5 Previous Clinical Trials
190 Total Patients Enrolled

Frequently Asked Questions

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

Has the FDA authorized LVGN3616 +LVGN6051+Nab-Paclitaxel for clinical use?

"The combination of LVGN3616, LVGN6051 and Nab-Paclitaxel have limited clinical data to support their safety and efficacy so they received a score of 1."

Answered by AI

What medical condition is the combination of LVGN3616 + LVGN6051 + Nab-Paclitaxel typically utilized to treat?

"LVGN3616 + LVGN6051 + Nab-Paclitaxel is the conventional remedy for leukamia, but it can also be used to address various other illnesses like non-small cell lung cancer with local advancement, metastatic bladder cancer and lung cancers."

Answered by AI

Has there been any previous research done on the combined use of LVGN3616, LVGN6051 and Nab-Paclitaxel?

"As of now, there are 420 Phase 3 trials and a total of 1868 studies concerning LVGN3616 + LVGN6051 + Nab-Paclitaxel. Most research sites can be found in Philadelphia, Pennsylvania; however, across the United States there are 76057 clinics researching this combination therapy."

Answered by AI

What is the aggregate population of those participating in this medical experiment?

"That is correct. The clinicaltrials.gov web page reveals that recruitment for this research study, which was initially publicized on November 12th 2021, is continuing as planned. 352 individuals are required from a single medical institution to complete the trial."

Answered by AI

Is this experiment still accepting participants?

"Affirmative. Clinicaltrials.gov displays that this large-scale trial, initially posted on November 12th 2021, is still open for enrollment and requires 352 individuals to be sourced from a single research site."

Answered by AI
~193 spots leftby Feb 2027