OncoMatch/Clinical Trials/NCT05301764
A Study of LVGN6051 Combined with Anlotinib in Patient with Soft Tissue Sarcoma
Is NCT05301764 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies LVGN6051 and Anlotinib for soft tissue sarcoma.
Treatment: LVGN6051 and Anlotinib — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Sarcoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: chemotherapy
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.
Cannot have received: anti-CD137 therapy
Prior therapy with anti-CD137 therapy.
Cannot have received: systemic anticancer therapy (including investigational agents or devices)
Exception: 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
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
Cannot have received: radiation therapy
Exception: within 14 days before the first dose of study treatment; previous radiotherapy to the CNS within 28 days of the first dose of study treatment
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].
Cannot have received: live-virus vaccine
Exception: within 30 days of the first dose of study drug
Received a live-virus vaccine within 30 days of the first dose of study drug.
Cannot have received: systemic immune-stimulatory agents (IL-2, IFNγ)
Exception: within 4 weeks prior to the first dose of study drug
Treatment with systemic immune-stimulatory agents (e.g., IL-2, IFNγ) within 4 weeks prior to the first dose of study drug.
Cannot have received: cell therapy (CAR T cell therapy)
Previous cell therapy (including but not limited to Car T cell therapy).
Cannot have received: allogeneic tissue/organ transplant, stem cell or bone marrow transplant or solid organ transplant
Previously received an allogeneic tissue/organ transplant, stem cell or bone marrow transplant or solid organ transplant.
Cannot have received: traditional Chinese medicine containing anticancer ingredients or with clear anticancer indications
Exception: elution period is 30 days
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.
Lab requirements
Blood counts
hemoglobin (Hb) ≥ 90 g/L, ANC ≥ 1.5x10^9/L, platelet count (PLT) ≥ 75x10^9/L.
Kidney function
estimated serum creatinine clearance of ≥ 50 mL/min (Cockcroft-Gault) or serum creatinine ≤1.5×ULN.
Liver function
Total bilirubin ≤ 1.5 × ULN; or ≤ 2.5 × ULN for patients with serum bilirubin increases due to underlying Gilbert's Syndrome or familial benign unconjugated hyperbilirubinemia. AST ≤ 1.5 × ULN, ALT ≤ 1.5× ULN. INR/PT/aPTT ≤ 1.5×ULN, for subjects on anticoagulant therapy, INR within therapeutic range. Amylase and lipase ≤1.5 × ULN.
Adequate bone marrow function, as defined by all of the following: hemoglobin (Hb) ≥ 90 g/L, ANC ≥ 1.5x10^9/L, platelet count (PLT) ≥ 75x10^9/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. AST ≤ 1.5 × ULN, ALT ≤ 1.5× ULN. INR/PT/aPTT ≤ 1.5×ULN, for subjects on anticoagulant therapy, INR within therapeutic range. Amylase and lipase ≤1.5 × ULN. Adequate renal function as defined by an estimated serum creatinine clearance of ≥ 50 mL/min (Cockcroft-Gault) or serum creatinine ≤1.5×ULN.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify