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Metastatic EsophagealPhase 1NCT05075993

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

A Phase 1 study testing LVGN3616 + LVGN6051 + Nab-Paclitaxel, LVGN3616 + LVGN6051 + Bevacizumab + Cyclophosphamide and LVGN3616 + LVGN6051 + LVGN7409 + Nab-Paclitaxel in people with Metastatic Esophageal and Gastric Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
LVGN3616 + LVGN6051 + Nab-Paclitaxel, LVGN3616 + LVGN6051 + Bevacizumab + Cyclophosphamide and LVGN3616 + LVGN6051 + LVGN7409 + Nab-Paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
352 participants
Where
1 siteUnited States
Study dates
12 Nov 2021to 2 Feb 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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 only).
  • PT/INR or partial thromboplastin time (PTT) test < 1.3 × the laboratory ULN if not on therapeutic anticoagulation.
  • Serum creatinine ≤ 1.5 × ULN or calculated creatinine clearance (CrCl) ≥ 45 mL/min by the Cockcroft-Gault method* or 24-hour urine collection.
  • CrCl = (140-age) x (weight/kg) x Fa / (72 x serum creatinine mg/dL). ^a where F= 0.85 for females and F=1 for males
  • Women of child-bearing potential (WOCBP) must have a negative serum pregnancy test within 3 days prior to initiation of therapy (C1D1) and must agree to use effective birth control during the study prior to the first dose and for at least 6 months after the last dose. Female patients are not considered to be of child-bearing potential if they are post-menopausal (no menses for 12 months without an alternative medical cause) or permanently sterile (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy). Male patients must agree to abstain or use barrier contraception (i.e., condoms) and avoid sperm donation for the duration of the study and for 6 months after treatment stops.
  • Ability to read and fully understand the requirements of the trial, willingness to comply with all trial visits and assessments, and willingness and ability to sign an institutional review board (IRB)-approved written informed consent document (ICD). Patients with Impaired Decision-Making Capacity (IDMC) must have a close caregiver or Legally Authorized Representative (LAR). For remote and In-person consenting, we will follow the Office of Clinical Research SOP:04 Informed Consent Process.
  • Any prior palliative radiation must have been completed at least 7 days prior to the start of study drugs, and patients must have recovered from any acute adverse effects prior to the start of study treatment (Radiotherapy for extended field within 2 weeks or limited field radiotherapy within 1 week).
  • Fridericia's corrected QT interval (QTcF =QT/∛(60/HR) ) ≤ 460 milliseconds (ms) for males and ≤ 480 ms for females on ECG conducted at rest during Screening.
  • Note: Patients with an atrioventricular pacemaker or other condition (for example, right bundle branch block) that renders the QT measurement invalid are an exception and this criterion does not apply.
  • Agreeing to provide an archival tissue block, or 10 formalin-fixed paraffin-embedded (FFPE) slides if available.
  • Prior treatment with immunotherapy, taxane, VEGF inhibition or cyclophosphamide is allowed. However, prior immunotherapy with anti-PD1/PD-L1 plus a CD137 agonist or a CD40 agonist is not allowed.

Who cannot join

  • Patients who meet any of the following criteria will be not eligible for the study:
  • Any treatment specifically for systemic tumor control given within 3 weeks before the initiation of therapy; within 2 weeks if cytotoxic agents were given weekly, within 6 weeks for nitrosoureas or mitomycin C; within 5 half-lives for targeted agents with half-lives and pharmacodynamic effects lasting < 5 days; or failure to recover from toxic effects of any previous therapy. A drug that has not received regulatory approval for any indication within 14 or 21 days of treatment for a non-myelosuppressive or myelosuppressive agent, respectively: patients must recover for previous cancer therapy, and are ready to proceed with further cancer therapy.
  • Uncontrolled intercurrent illness including but not limited to:
  • ongoing or active infection requiring intravenous antibiotics
  • symptomatic congestive heart failure (New York Heart Association Class III or IV)
  • history of myocardial infarction, unstable angina, stroke or transient ischemic attack within 6 months before study enrollment
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  • lesions invading or encasing any major blood vessels and cavitating pulmonary lesion(s) or known endotracheal or endobronchial disease manifestation. Uncontrolled hypertension defined as sustained blood pressure (BP) > 140 mm Hg systolic or > 90 mm Hg diastolic despite optimal antihypertensive treatment (apply to bevacizumab-based regimens only)
  • history or current evidence of uncontrolled ventricular arrhythmia
  • congenital long QT syndrome, or any known history of torsade de pointes, or family history of unexplained sudden death
  • clinically significant bleeding or active gastric or duodenal ulcer
  • chronic diarrhea diseases considered to be clinically significant by investigator
  • Abdominal fistula, GI perforation, bowel obstruction, or intra-abdominal abscess within 6 months before first dose of study treatment, or any gastrointestinal disorders associated with a high risk of perforation or fistula formation
  • other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation, or may interfere with the interpretation of study results, and in the judgment of the Investigator would make the patient inappropriate for entry into this study Note: Subjects with a diagnosis of incidental, subsegmental pulmonary embolism or deep vein thrombosis are allowed if stable, asymptomatic, and treated with a stable dose of permitted anticoagulation for at least 1 week before first dose of study treatment.
  • Unresolved clinically significant Grade 1 or higher toxicity from prior therapy.
  • History of allergic reactions to the study drugs, or any component of the products.
  • Presence of other active invasive cancers that requires active treatment other than hormonal therapy.
  • Having not recovered from a major surgical procedure or significant traumatic injury (i.e., still needing additional surgical or medical care for these issues): major surgical procedures ≤ 28 days of treatment entry, or minor surgical procedures ≤ 7 days. No waiting period required following port-a-cath or other central venous access placement. Subjects must have complete wound healing from major surgery or minor surgery before first dose of study treatment. Subjects with clinically relevant ongoing complications from prior surgery are not eligible.
  • Currently receiving an investigational drug in a clinical trial or participating in any other type of medical research judged not to be scientifically or medically compatible with this study. If a patient is currently enrolled in a clinical trial involving non-approved use of a therapeutic device for cancer control, then agreement with the investigator and the sponsor (MD Anderson IND Office) is required to establish eligibility.
  • Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: Bacille Calmette-Guérin vaccine, measles, mumps, rabies, rubella, typhoid vaccine, varicella/zoster, and yellow fever. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines are live attenuated vaccines and are not allowed. COVID19 vaccines including killed virus are allowed.
  • Caution should be exercised when administering nab-paclitaxel concomitantly with known substrates or inhibitors of CYP2C8 and CYP3A4 (https://www.fda.gov/drugs/drug-interactions-labeling/drug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers).
  • Symptomatic primary tumors or metastasis in the brain and/or central nervous system that are uncontrolled with antiepileptics and/or require steroids at a dose of prednisone > 10 mg/day or equivalent.
  • Evidence of leptomeningeal or lymphangitic carcinomatosis.
  • A history of another primary malignancy that is currently clinically significant, requiring active intervention except for hormone therapy.
  • Lactation or pregnancy.
  • Human immunodeficiency virus requiring HAART treatment due to unknown drug-drug interactions or has known active hepatitis B (e.g., HBsAg reactive) or C virus (e.g., HCV RNA [quantitative] is detected) infection: patients who have had active HBV or HCV infections in the past but have evidence of viral clearance as shown by negative viral load, i.e., undetectable HBV DNA or HCV RNA, will be eligible.
  • Concurrent immunosuppressive therapy or steroid (> 10 mg/day prednisone or equivalent).
  • History of autoimmune disease including but not limited to inflammatory bowel disease, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis, which requires systemic therapy in the past 2 years.
  • Note: Patients with vitiligo, resolved childhood asthma/atopy, hypothyroidism on stable hormone replacement, controlled asthma, Type I diabetes, Graves' disease, or Hashimoto's disease, are not excluded.
  • History of grade ≥ 3 immune-related adverse events with previous immunotherapy. Note: Patients with adequately treated skin rash other than Steven-Johnson, toxic epidermal necrolysis of other severe forms of dermatitis; or replacement therapy for endocrinopathies, are not excluded.
  • History of interstitial lung disease or (non-infectious) pneumonitis that required steroids or current pneumonitis.
  • History of grade ≥ 3 allergic reaction to treatment with a monoclonal antibody.
  • Patients with Urinary Outflow Obstruction (apply to cyclophosphamide-based regimens only).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • M D Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

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:

Read the detailed description

Primary Objectives:

  1. To determine the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of LVGN3616 and LVGN6051 ± LVGN7409 in combination with nab-paclitaxel or bevacizumab and cyclophosphamide (4 individual regimens).
  2. To evaluate antitumor activity of LVGN3616 and LVGN6051 ± LVGN7409 in combination with nab-paclitaxel or bevacizumab and cyclophosphamide (16 specific cohorts according to disease type and regimen).

Secondary Objectives:

  • To assess survivals.
  • To explore potential baseline biomarkers.
  • To explore patient-reported outcomes (PRO).
Being tested
LVGN3616 + LVGN6051 + Nab-Paclitaxel, LVGN3616 + LVGN6051 + Bevacizumab + Cyclophosphamide, LVGN3616 + LVGN6051 + LVGN7409 + Nab-Paclitaxel, LVGN3616 + LVGN6051 + LVGN7409 + Bevacizumab + Cyclophosphamide
Medical subject headings
Stomach Neoplasms, Carcinoma, Hepatocellular, Ovarian Neoplasms, Sarcoma, Uveal Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LVGN3616 + LVGN6051 + Nab-PaclitaxelDrug

    Given by IV, Given by PO

  • LVGN3616 + LVGN6051 + Bevacizumab + CyclophosphamideDrug

    Given by IV, Given by PO

  • LVGN3616 + LVGN6051 + LVGN7409 + Nab-PaclitaxelDrug

    Given by IV, Given by PO

  • LVGN3616 + LVGN6051 + LVGN7409 + Bevacizumab + CyclophosphamideDrug

    Given by IV, Given by PO

Study groups in NCT05075993
Study groupRoleWhat they receive
Regimen A: LVGN3616 + LVGN6051 + Nab-PaclitaxelExperimentalgiven 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).
Receives: Drug: LVGN3616 + LVGN6051 + Nab-Paclitaxel; Drug: LVGN3616 + LVGN6051 + Bevacizumab + Cyclophosphamide; Drug: LVGN3616 + LVGN6051 + LVGN7409 + Nab-Paclitaxel; Drug: LVGN3616 + LVGN6051 + LVGN7409 + Bevacizumab + Cyclophosphamide
Regimen B: LVGN3616 + LVGN6051 + Bevacizumab + CyclophosphamideExperimentalgiven 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).
Receives: Drug: LVGN3616 + LVGN6051 + Nab-Paclitaxel; Drug: LVGN3616 + LVGN6051 + Bevacizumab + Cyclophosphamide; Drug: LVGN3616 + LVGN6051 + LVGN7409 + Nab-Paclitaxel; Drug: LVGN3616 + LVGN6051 + LVGN7409 + Bevacizumab + Cyclophosphamide
Regimen C: LVGN3616 + LVGN6051 + LVGN7409 + Nab-PaclitaxelExperimentalgiven 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).
Receives: Drug: LVGN3616 + LVGN6051 + Nab-Paclitaxel; Drug: LVGN3616 + LVGN6051 + Bevacizumab + Cyclophosphamide; Drug: LVGN3616 + LVGN6051 + LVGN7409 + Nab-Paclitaxel; Drug: LVGN3616 + LVGN6051 + LVGN7409 + Bevacizumab + Cyclophosphamide
Regimen D: LVGN3616 + LVGN6051 + LVGN7409 + Bevacizumab + CyclophosphamideExperimentalgiven 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).
Receives: Drug: LVGN3616 + LVGN6051 + Nab-Paclitaxel; Drug: LVGN3616 + LVGN6051 + Bevacizumab + Cyclophosphamide; Drug: LVGN3616 + LVGN6051 + LVGN7409 + Nab-Paclitaxel; Drug: LVGN3616 + LVGN6051 + LVGN7409 + Bevacizumab + Cyclophosphamide

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Oct 2021
  2. Study start12 Nov 2021
  3. Primary completion2 Feb 2027 (estimated)
  4. Study completion2 Feb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
352 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05075993
Sponsor's protocol ID
2021-0176
Other IDs
NCI-2021-10729
Status last verified
Jun 2026
First submitted
22 Sep 2021
Last updated
12 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LVGN3616 + LVGN6051 + Nab-Paclitaxel, LVGN3616 + LVGN6051 + Bevacizumab + Cyclophosphamide and LVGN3616 + LVGN6051 + LVGN7409 + Nab-Paclitaxel in people with Metastatic Esophageal and Gastric Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To establish the maximum tolerated dose (MTD)/recommended. (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05075993.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.

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