Active — Not RecruitingPhase 1

Study of LVGN3616 and LVGN6051±LVGN7409 in Combination With Nab-Paclitaxel or Bevacizumab and Cyclophosphamide in Metastatic Solid Tumors

United States352 participantsStarted 2021-11-12

Plain-language summary

This is an investigator-initiated industry-supported phase 1 clinical trial conducted in the phase 1 clinic at The University of Texas MD Anderson Cancer Center who will hold the Investigational New Drug (IND). Lvygen Biopharma will provide as investigational supply LVGN3616, LVGN6051 and LVGN7409 at no cost to the patients on this study. This study will explore antitumor activity of four LVGN3616 and LVGN6051 based regimens in seven selected tumor types:

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: To be eligible for this trial, patients must meet all the following eligibility criteria. * Patients must have histologically confirmed metastatic solid tumors with pre-identified molecular profiling in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory, either refractory to standard therapy or for which no effective standard therapy that increases survival for at least 3 months is available, or they declined standard of care therapy (the treating physician needs document reasons for a patient to decline standard of care therapy and provide justification for participating this study in the medical record, which will be recorded in eCRF). * Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. * Male or female aged ≥18 years. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. * Adequate organ functions as defined below: * Absolute neutrophil count (ANC) ≥ 1,500 /μL. * Hemoglobin (Hb) ≥ 8.5 g/dL. * Platelets ≥ 100,000 /μL for nab-paclitaxel or ≥ 75,000 /μL for cyclophosphamide. * Total bilirubin ≤ 1.5 × upper limit of normal (ULN); or total bilirubin \< 3.0 × ULN with direct bilirubin ≤ ULN in patients with well documented Gilbert's Syndrome. * ALT and AST ≤ 2.5 × ULN. * Serum albumin ≥ 3 g/dL. * Urinalysis ≤ 1 proteinuria, or urine protein/creatinine ratio (UPCR) ≤ 1 mg/mg (≤ 113.2 mg/mmol), or 24-h urine protein ≤ 1 g (apply to bevacizumab-based regimens onl…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To establish the maximum tolerated dose (MTD)/recommended.

Timeframe: through study completion, an average of 1 year

Trial details

NCT IDNCT05075993

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-02-02

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