Soft Tissue SarcomaPhase 1/2NCT05301764
A Study of LVGN6051 Combined With Anlotinib in Patient With Soft Tissue Sarcoma
A Phase 1/2 study testing LVGN6051 and Anlotinib in people with Soft Tissue Sarcoma, run by Lyvgen Biopharma Holdings Limited at 5 sites in China.
Trial summary
The purpose of this study is to asess the safety and tolerability and efficacy of LVGN6051 combined with anlotinib in patient with soft tissue sarcoma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Soft Tissue Sarcoma
- What is being tested?
- LVGN6051 and Anlotinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 5 sitesChina
- Study dates
- 25 May 2022to 19 Dec 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females aged ≥ 18 years, who was histologically or cytologically diagnosed unresectable locally advanced, metastatic or recurrent refractory soft tissue sarcoma.
- Ability to understand and willingness to sign a written informed consent document (ICF). Informed consent of subjects must be performed before the study, and the written informed consent shall be voluntarily signed by himself or his guardian; The subject or his guardian can communicate well with the investigator, and perform according to the protocol.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
- Estimated life expectancy, in the judgment of the Investigator, of at least 90 days.
- Adequate bone marrow function, as defined by all of the following:
- hemoglobin (Hb) ≥ 90 g/L, and
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- absolute neutrophil count (ANC) ≥ 1.5x109/L, and
- platelet count (PLT) ≥ 75x109/L.
- Adequate liver function, as defined by all of the following:
- Total bilirubin ≤ 1.5 × ULN; or ≤ 2.5 × ULN for patients who have serum bilirubin increases due to underlying Gilbert's Syndrome or familial benign unconjugated hyperbilirubinemia.
- Aspartate Aminotransferase (AST) ≤ 1.5 × ULN, and Alanine Transaminase (ALT) ≤ 1.5× ULN.
- International normalized ratio (INR) or prothrombin time (PT), activated partial thromboplastin time (aPTT) ≤ 1.5×ULN, for subjects who are receiving anticoagulant therapy, INR level should be within therapeutic range.
- Amylase and lipase ≤1.5 × ULN
- Adequate renal function as defined by an estimated serum creatinine clearance of ≥ 50 mL/min (calculated by Cockcroft-Gault formula) or serum creatinine≤1.5×ULN.
- Women of childbearing potential must agree to abstain from heterosexual intercourse or use highly effective contraceptive methods from the time of signing informed consent and through 120 days after the last dose of study drug. Should a woman become pregnant or suspect she is pregnant while she (or her partner) is participating in this study, she should inform her research physician immediately.
- A woman of childbearing potential is any woman, regardless of sexual orientation, who meets the following criteria: 1. has not undergone tubal ligation, a hysterectomy, or bilateral oophorectomy; or 2. has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
- Men enrolled on this study must agree to abstain, be surgically sterilized, or agree to use highly effective methods of contraception, including barrier contraception from the time of signing informed consent and through 120 days after the last dose of study drug.
- Patients should recover from all reversible clinically significant AEs of previous anticancer therapies to baseline or NCI-CTCAE v. 5.0 Grade 0-1, except for alopecia (any Grade), Grade < 2 sensory or motor peripheral neuropathy, lymphopenia, or hypothyroidism on hormone replacement (Grade 2), within 14 days prior to the first dose on study. Inclusion of patients with other toxicities deemed not clinically significant (Grade ≤ 2) should be discussed and approved by the Medical Head of Sponsor.
- All patients must have at least one measurable lesion as defined by RECIST v1.1 for solid tumors.
- All patients with advanced/metastatic soft tissue sarcoma receiving LVGN6051 combinated with Anlotinib must have received one prior line of approved chemotherapy and disease progresses or intolerance confirmed by imaging examination before enrollment. Approved chemotherapy must include anthracycline, except acinar soft tissue sarcoma and clear cell sarcoma, which can be included in patients with recurrence or metastasis who are newly diagnosed or who only receive surgical treatment.
Who cannot join
- Prior therapy with anti-CD137 therapy.
- Receipt of systemic anticancer therapy including investigational agents or devices within 5 half-lives of the first dose of study treatment. For anticancer therapies with half-life greater than 5 days, a washout of 28 days or longer is acceptable
- The subject was experienced radiotherapy within 14 days before the first dose of study treatment. [Previous radiotherapy to the central nervous system (CNS) within 28 days of the first dose of study treatment].
- Known unstable CNS metastasis and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are clinically and radiographically stable, without evidence of recurrence/progression, have no evidence of new or enlarging brain metastases or cephaledema, and are using no corticosteroids for at least 7 days prior to study medication.
- Received a live-virus vaccine within 30 days of the first dose of study drug.
- Grade ≥ 3 allergic reaction to treatment with a monoclonal antibody or has a known or suspected hypersensitivity to components of the study treatment(s).
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- Baseline QT interval corrected by Fridericia's formula (QTcF) > 480 milliseconds or known to have congenital prolonged QT syndrome.
- History of Grade ≥ 3 immune-related AEs (irAEs). Exceptions: hypothyroidism, type 1 diabetes mellitus (Type 1 DM), and dermatologic irAEs (patients with previous Steven Johnson Syndrome, toxic epidermal necrolysis or other severe forms of dermatitis are ineligible) are allowed. Type 1 DM should be controlled with HbA1c <8% as per ADA recommendation.
- Receiving an immunologically based treatment for any reason, including chronic use of systemic steroids equivalent to > 10 mg/day of prednisone within 7 days of the first dose of study drug or at any time during study participation.
- Note: Use of inhaled or topical steroids or systemic corticosteroids equivalent to ≤ 10 mg/day prednisone equivalent is permitted as is short-term use of corticosteroids at doses equivalent to > 10 mg/day of prednisone (e.g., pre-medication prior to contrast).
- Treatment with systemic immune-stimulatory agents (e.g., IL-2, IFNγ) within 4 weeks prior to the first dose of study drug.
- History or current active or chronic 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 that has required systemic treatment in the past 2 years or who are receiving systemic therapy for an autoimmune or inflammatory disease.
- Exception: Patients with vitiligo or resolved childhood asthma/atopy, hypothyroidism on stable hormone replacement, controlled asthma, Type I diabetes, Graves' disease, Hashimoto's disease, or with Medical Monitor approval.
- Clinically significant cardiac condition, including unstable angina, acute myocardial infarction within 6 months of Cycle 1 Day 1, New York Heart Association Class III or IV congestive heart failure, unstable angina pectoris or arrhythmia requiring therapy.
- Note: A patient with an arrhythmia may enroll if the patient is on antiarrhythmic medication and is in a rate- controlled rhythm on the screening electrocardiogram (ECG).
- Pleural effusion or pericardial effusion with uncontrolled or requiring repeat drainage (recurrence within two weeks after intervention), or recurrent ascites requiring drainage ≥ once a month.
- Active infection requiring intravenous (IV) anti-infectives within 14 days before the first dose of study treatment, or nonhealing wound or ulcer.
- Current evidence or history of interstitial lung disease or active, noninfectious pneumonitis requiring treatment such as oral or intravenous glucocorticoids.
- Female patients who are pregnant or breastfeeding (confirmation that the patient is not pregnant must be by a negative serum pregnancy test result obtained during screening; pregnancy testing is required of women of childbearing potential but not required for postmenopausal or surgically sterilized women).
- Any evidence of severe or uncontrolled systemic disease including, but not limited to, active bleeding diathesis, organ transplantation.
- Subjects with known positive test results of human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
- Subjects with known active hepatitis B [hepatitis B surface antigen (HBsAg) positive] and / or hepatitis B core antibody (HBcAb) positive and hepatitis B virus DNA (HBV DNA) ≥ 104 copies/ml or 2000IU/ml) or hepatitis C virus RNA (HCV RNA) positive were known
- Any other disease or clinically significant abnormality in laboratory parameters, including serious medical or psychiatric illnesses/conditions, which in the judgment of the Investigator might compromise the safety of the patient, integrity of the study, interfere with the patient participation in the study, or compromise the study objectives.
- Previously received an allogeneic tissue/organ transplant, stem cell or bone marrow transplant or solid organ transplant.
- Previous cell therapy (including but not limited to Car T cell therapy).
- The investigator believes subject has other acute or serious or chronic medical or psychological diseases and he is not suitable to participate in the clinical trial.
- Traditional Chinese medicine containing anticancer ingredients or with clear anticancer indications has been used in the past (auxiliary drugs were not included), and the elution period is 30 days.
- Other malignant tumors ≤5 years before the first dose. Exceptions are: early stage malignancies that have been radically cured (carcinoma in situ or stage I tumours), such as carcinoma in situ of the cervix, basal cell or squamous cell skin cancers that have been adequately treated.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Hunan Cancer Hospital
Changsha, Hunan, 410031
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310052
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, 200233
Henan cancer hospital
Zhenzhou, Henan, 450008
About this study
Official title: An Open Label, Phase Ib/II Trial of LVGN6051 Combined With Anlotinib in the Treatment of Locally Advanced, Metastatic or Recurrent Refractory Soft Tissue Sarcoma
The purpose of this study is to asess the safety and tolerability and efficacy of LVGN6051 combined with anlotinib in patient with soft tissue sarcoma.
Read the detailed description
This is a phase 1b/II, open-label, multicenter study of LVGN6051 combined with anlotinib in patients with locally advanced, metastatic or recurrent refractory soft tissue sarcoma.
The study is comprised of a dose escalation phase (Ib) to determine the RP2D and an expansion phase (II) to further explore the safety and efficacy of combination treatment.
- Conditions
- Soft Tissue Sarcoma
- Being tested
- LVGN6051 and Anlotinib
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LVGN6051 and AnlotinibCombination product
LVGN6051: 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. Anlotinib: Rout of administration is oral. The initial dose of anlotinib was 12 mg for subjects with body surface area ≥ 1.5m2 and 10 mg for subjects with body surface area < 1.5m2. If the subjects in the combined treatment group were not tolerated, the dose of anlotinib was reduced to 10 mg for subjects with body surface area ≥ 1.5m2 and 8 mg for subjects with body surface area < 1.5m2.
One cycle is 3 weeks, including oral for 2 weeks and withdrawal for 1 week.
| Study group | Role | What they receive |
|---|---|---|
| LVGN6051 combined with Anlotinib | Experimental | LVGN6051 Dose Escalation in the combination treatment with Anlotinib Receives: Combination Product: LVGN6051 and Anlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
To characterize the safety and tolerability of LVGN6051 combined with Anlotinib and to recommend the Phase II dose
To evaluate the safety and tolerability of LVGN6051 combined with Anlotinib through evaluation of the frequency and severity of AEs, serious adverse events(SAEs)
Measured: Up to 24 months
To characterize the safety and tolerability of LVGN6051 combined with Anlotinib and to recommend the Phase II dose
To evaluate the safety and tolerability of LVGN6051 combined with Anlotinib through evaluation of the type of dose-limiting toxicities (DLTs)
Measured: At the end of Cycle 1 (each cycle is 21 days)
to determine objective response rate (ORR) of phase II
To assess the preliminary efficacy of LVGN6051 combined with Anlotinib in terms of objective response rate (ORR).
Measured: Up to 24 months
Secondary outcomes (13)
To characterize the safety and tolerability of LVGN6051 combined with Anlotinib
To evaluate the safety and tolerability of LVGN6051 combined with Anlotinib through evaluation of the frequency and severity of AEs, Treatment-emergent Adverse Events (TEAEs), immune-related AEs (irAEs), treatment-related adverse events TRAEs), and laboratory results, Vital Signs, Physical examinations.
Measured: Up to 24 months
To assess preliminary efficacy on overall survival (OS)(for Phase II only) using LVGN6051 combined with Anlotinib
To assess the preliminary efficacy of LVGN6051 combined with Anlotinib in terms of overall survival (OS)(for Phase II only)
Measured: Up to 24 months
To assess preliminary efficacy on progression-free survival (PFS) using LVGN6051 combined with Anlotinib
To assess the preliminary efficacy of LVGN6051 combined with Anlotinib in terms of progression-free survival (PFS)
Measured: Up to 24 months
To assess preliminary efficacy on duration of response (DoR) using LVGN6051 combined with Anlotinib
To assess the preliminary efficacy of LVGN6051 combined with Anlotinib in terms of duration of response (DoR)
Measured: Up to 24 months
To assess preliminary efficacy on disease control rate (DCR) using LVGN6051 combined with Anlotinib
To assess the preliminary efficacy of LVGN6051 combined with Anlotinib in terms of disease control rate (DCR)
Measured: Up to 24 months
To assess whether the anti-drug antibody (ADA) of LVGN6051 exist or not
To evaluate the ADA of LVGN6051 by the number of ADA cases and incidence of ADA.
Measured: Up to 24 months
To characterize the PK (Pharmacokinetic) profile of LVGN6051
PK exposure parameters derived from plasma concentrations of LVGN6051
Measured: Up to 24 months
To explore the biomarkers based on the tumor tissue sample
To explore the correlation between biomarkers and antitumor efficacy, including PD-L1 (programmed cell death-Ligand 1), MSI/dMMR (Microsatellite Instability/Deficient Mismatch Repair), TMB (Tumor Mutation Burden).
Measured: Up to 24 months
To explore the biomarker IL-6 (interleukin- 6) based on the serum samples.
To explore the changes of biomarker IL-6 (interleukin- 6) after LVGN6051 and anlotinib treatment
Measured: Up to 15 days
To explore the biomarker IL-12 (interleukin- 12) based on the serum samples.
To explore the changes of biomarker IL-12 (interleukin- 12) after LVGN6051 and anlotinib treatment
Measured: Up to 15 days
To explore the biomarker TNF-α (Tumor Necrosis Factor-α) based on the serum samples.
To explore the changes of biomarker TNF-α (Tumor Necrosis Factor-α) after LVGN6051 and anlotinib treatment
Measured: Up to 15 days
To explore the biomarker IFN-γ (Interferon Gamma) based on the serum samples.
To explore the changes of biomarker IFN-γ (Interferon Gamma) after LVGN6051 and anlotinib treatment
Measured: Up to 15 days
To explore the biomarker CD137 (also known as 4-1BB) based on the serum samples.
To explore the changes of biomarker CD137 (also known as 4-1BB) after LVGN6051 and anlotinib treatment
Measured: Up to 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start25 May 2022
- Primary completion19 Dec 2025
- Study completion19 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue SarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lyvgen Biopharma Holdings Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Haiyan Hu, Principal investigator, Shanghai 6th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05301764
- Sponsor's protocol ID
- LVGN6051-301
- Status last verified
- May 2026
- First submitted
- 2 Mar 2022
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Phase Ib/II Trial of LVGN6051 Combined With Anlotinib in the Treatment of Locally Advanced, Metastatic or Recurrent Refractory Soft Tissue Sarcoma
- ClinicalTrials.gov ID
- NCT05301764
- Acronym / sponsor ID
- LVGN6051-301
- Conditions
- Soft Tissue Sarcoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Lyvgen Biopharma Holdings LimitedIndustry (pharma, biotech, devices)
- Study start
- 25 May 2022 (actual)
- Primary completion
- 19 Dec 2025 (actual)
- Study completion
- 19 Dec 2025 (actual)
- First posted
- 31 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to asess the safety and tolerability and efficacy of LVGN6051 combined with anlotinib in patient with soft tissue sarcoma.
Detailed description
This is a phase 1b/II, open-label, multicenter study of LVGN6051 combined with anlotinib in patients with locally advanced, metastatic or recurrent refractory soft tissue sarcoma.
The study is comprised of a dose escalation phase (Ib) to determine the RP2D and an expansion phase (II) to further explore the safety and efficacy of combination treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LVGN6051 combined with Anlotinib | Experimental | Combination Product: LVGN6051 and AnlotinibLVGN6051 Dose Escalation in the combination treatment with Anlotinib |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Males or females aged ≥ 18 years, who was histologically or cytologically diagnosed unresectable locally advanced, metastatic or recurrent refractory soft tissue sarcoma.
- Ability to understand and willingness to sign a written informed consent document (ICF). Informed consent of subjects must be performed before the study, and the written informed consent shall be voluntarily signed by himself or his guardian; The subject or his guardian can communicate well with the investigator, and perform according to the protocol.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
- Estimated life expectancy, in the judgment of the Investigator, of at least 90 days.
- Adequate bone marrow function, as defined by all of the following:
Key exclusion criteria (28 listed)
- Prior therapy with anti-CD137 therapy.
- Receipt of systemic anticancer therapy including investigational agents or devices within 5 half-lives of the first dose of study treatment. For anticancer therapies with half-life greater than 5 days, a washout of 28 days or longer is acceptable
- The subject was experienced radiotherapy within 14 days before the first dose of study treatment. [Previous radiotherapy to the central nervous system (CNS) within 28 days of the first dose of study treatment].
- Known unstable CNS metastasis and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are clinically and radiographically stable, without evidence of recurrence/progression, have no evidence of new or enlarging brain metastases or cephaledema, and are using no corticosteroids for at least 7 days prior to study medication.
- Received a live-virus vaccine within 30 days of the first dose of study drug.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LVGN6051 and AnlotinibLVGN6051: 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. Anlotinib: Rout of administration is oral. The initial dose of anlotinib was 12 mg for subjects with body surface area ≥ 1.5m2 and 10 mg for subjects with body surface area < 1.5m2. If the subjects in the combined treatment group were not tolerated, the dose of anlotinib was reduced to 10 mg for subjects with body surface area ≥ 1.5m2 and 8 mg for subjects with body surface area < 1.5m2. One cycle is 3 weeks, including oral for 2 weeks and withdrawal for 1 week. | Combination product | LVGN6051 combined with Anlotinib |
Primary outcome
To characterize the safety and tolerability of LVGN6051 combined with Anlotinib and to recommend the Phase II dose
Time frame: Up to 24 months
To evaluate the safety and tolerability of LVGN6051 combined with Anlotinib through evaluation of the frequency and severity of AEs, serious adverse events(SAEs)
To characterize the safety and tolerability of LVGN6051 combined with Anlotinib and to recommend the Phase II dose
Time frame: At the end of Cycle 1 (each cycle is 21 days)
To evaluate the safety and tolerability of LVGN6051 combined with Anlotinib through evaluation of the type of dose-limiting toxicities (DLTs)
to determine objective response rate (ORR) of phase II
Time frame: Up to 24 months
To assess the preliminary efficacy of LVGN6051 combined with Anlotinib in terms of objective response rate (ORR).
13 secondary outcomes
To characterize the safety and tolerability of LVGN6051 combined with Anlotinib
Time frame: Up to 24 months
To assess preliminary efficacy on overall survival (OS)(for Phase II only) using LVGN6051 combined with Anlotinib
Time frame: Up to 24 months
To assess preliminary efficacy on progression-free survival (PFS) using LVGN6051 combined with Anlotinib
Time frame: Up to 24 months
To assess preliminary efficacy on duration of response (DoR) using LVGN6051 combined with Anlotinib
Time frame: Up to 24 months
To assess preliminary efficacy on disease control rate (DCR) using LVGN6051 combined with Anlotinib
Time frame: Up to 24 months
To assess whether the anti-drug antibody (ADA) of LVGN6051 exist or not
Time frame: Up to 24 months
To characterize the PK (Pharmacokinetic) profile of LVGN6051
Time frame: Up to 24 months
To explore the biomarkers based on the tumor tissue sample
Time frame: Up to 24 months
To explore the biomarker IL-6 (interleukin- 6) based on the serum samples.
Time frame: Up to 15 days
To explore the biomarker IL-12 (interleukin- 12) based on the serum samples.
Time frame: Up to 15 days
To explore the biomarker TNF-α (Tumor Necrosis Factor-α) based on the serum samples.
Time frame: Up to 15 days
To explore the biomarker IFN-γ (Interferon Gamma) based on the serum samples.
Time frame: Up to 15 days
To explore the biomarker CD137 (also known as 4-1BB) based on the serum samples.
Time frame: Up to 15 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haiyan Hu principal investigator
Shanghai 6th People's Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing LVGN6051 and Anlotinib in people with Soft Tissue Sarcoma, run by Lyvgen Biopharma Holdings Limited at 5 sites in China.
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 20 inclusion and 28 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: finished, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 characterize the safety and tolerability of LVGN6051 combined with Anlotinib and to recommend the Phase II dose (time frame: Up to 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 May 2026.