Study of LVGN3616 and LVGN6051±LVGN7409 in Combination With Nab-Paclitaxel or Bevacizumab and Cyclophosphamide in Metastatic Solid Tumors
2 other identifiers
interventional
352
1 country
1
Brief 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:
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Nov 2021
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 22, 2021
CompletedFirst Posted
Study publicly available on registry
October 13, 2021
CompletedStudy Start
First participant enrolled
November 12, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 2, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 2, 2027
December 26, 2025
December 1, 2025
5.2 years
September 22, 2021
December 19, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
To establish the maximum tolerated dose (MTD)/recommended.
through study completion, an average of 1 year
Study Arms (4)
Regimen A: LVGN3616 + LVGN6051 + Nab-Paclitaxel
EXPERIMENTALgiven 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).
Regimen B: LVGN3616 + LVGN6051 + Bevacizumab + Cyclophosphamide
EXPERIMENTALgiven 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).
Regimen C: LVGN3616 + LVGN6051 + LVGN7409 + Nab-Paclitaxel
EXPERIMENTALgiven 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).
Regimen D: LVGN3616 + LVGN6051 + LVGN7409 + Bevacizumab + Cyclophosphamide
EXPERIMENTALgiven 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).
Interventions
Given by IV, Given by PO
Given by IV, Given by PO
Given by IV, Given by PO
Given by IV, Given by PO
Eligibility Criteria
You may qualify if:
- 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 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.
- +8 more criteria
You may not qualify if:
- 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
- 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.
- +17 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- Lyvgen Biopharma Holdings Limitedcollaborator
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Siqing Fu
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 22, 2021
First Posted
October 13, 2021
Study Start
November 12, 2021
Primary Completion (Estimated)
February 2, 2027
Study Completion (Estimated)
February 2, 2027
Last Updated
December 26, 2025
Record last verified: 2025-12