A Study of LVGN6051 Combined With Anlotinib in Patient With Soft Tissue Sarcoma (NCT05301764) | Clinical Trial Compass
CompletedPhase 1/2
A Study of LVGN6051 Combined With Anlotinib in Patient With Soft Tissue Sarcoma
China39 participantsStarted 2022-05-25
Plain-language 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.
Who can participate
Age range
18 Years – 70 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
. 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
. absolute neutrophil count (ANC) ≥ 1.5x109/L, and
. platelet count (PLT) ≥ 75x109/L.
Exclusion criteria
. Prior therapy with anti-CD137 therapy.
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
1
To characterize the safety and tolerability of LVGN6051 combined with Anlotinib and to recommend the Phase II dose
Timeframe: Up to 24 months
2
To characterize the safety and tolerability of LVGN6051 combined with Anlotinib and to recommend the Phase II dose
Timeframe: At the end of Cycle 1 (each cycle is 21 days)
3
to determine objective response rate (ORR) of phase II
. 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).
. 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.