Clinical trial · Interventional
A Study of HG381 Administered to Patients With Advanced Solid Tumors
Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of HG381 as Monotherapy in Patients With Advanced Solid Tumors
NCT04998422CI-TRIAL-00087151recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 18, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260918-000001
Summary
Brief summary (as posted)
This is a Phase I, first in human, open-label, non-randomized, multicenter study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, preliminary efficacy and establish a recommended dose of HG381 administered intravenously (IV) alone in subjects with advanced solid tumors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HG381 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Part A: HG381 Monotherapy Dose Escalation Cohort
- description
- Subjects will receive HG381 IV at every one week intervals (Q1W). Escalating doses of HG381 will be evaluated by the traditional 3+3 design.
- interventionNames
- Drug: HG381
- type
- EXPERIMENTAL
- label
- Part B: HG381 Monotherapy Dose Expansion Cohort
- description
- Subjects will be administered the recommended Phase 2 dose of HG381 IV Q1W established in Part A of the study.
- interventionNames
- Drug: HG381
Primary outcomes (4)
- measure
- Number of subjects achieving Dose-limiting toxicity (DLT)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Capable of giving signed informed consent. * Life expectancy of at least 3 months. * Histological or cytological documentation of an advanced solid tumor,subjects with advanced/recurrent solid tumors, who have progressed on, be intolerant of, or ineligible for, all available therapies for which clinical benefit has been established. * Measurable disease per RECIST version 1.1, there is at least one measurable lesion during the screening period. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1. * Adequate organ function : Hematologic system: Hemoglobin ≥9 g/dL, Absolute neutrophil count \[ANC\] ≥1.5x10\^9/L, Platelets ≥100x10\^9/L, INR ≤ 1.5 and APTT ≤1.5 x ULN; Hepatic system: Total bilirubin ≤1.5 x ULN, ALT and AST ≤ 2.5 x ULN; Renal system: serum creatinine ≤1.5×ULN or creatinine clearance ≥50 mL/min (calculated by the Cockcroft-Gault formula); Cardiac system: left ventricular ejection fraction (LVEF) ≥50% ; QT interval (QTcF) ≤470 ms for women, and ≤450 ms for men; Endocrine system: Thyroid-stimulating hormone (TSH) is within the normal limits. * Subjects with fertility must agree to take medically approved effective contraceptive measures during the entire trial period and at least 3 months after the last medication. Exclusion Criteria: * Chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy and other anticancer therapy within 4 weeks. * Concurrent medical condition requiring the use of other systemic immunosuppressive treatment within 4 weeks before the first dose of study treatment. * Receipt of any live vaccine within 4 weeks of the start of study treatment. * Receipt of unmarketed clinical trial drugs or treatments within 4 weeks of the start of study treatment. * Receipt of surgery or interventional treatment (excluding tumor biopsy, puncture, etc.) within 4 weeks of the start of study treatment. * History or evidence of cardiovascular and cerebrovascular diseases risk. * Subjects with uncontrolled diabetes. * Symptomatic central nervous system (CNS) metastases or asymptomatic CNS metastases that have required steroids within 2 weeks prior to first dose of study treatment. * Currently or in the past suffering from malignant tumors. * Uncontrollable pleural effusion, pericardial effusion or ascites still need to be drained frequently after appropriate intervention. * Active or suspected autoimmune disease. * History of idiopathic pulmonary fibrosis, interstitial lung disease, or organizing pneumonia, or evidence of active, non-infectious pneumonitis. * Toxicity from previous treatment including: Toxicity Grade ≥3 related to prior immunotherapy and that led to study treatment discontinuation; Toxicity related to prior treatment that has not resolved to Grade ≤ 1. * Subjects who have acute bacterial, viral or fungal infections and require systemic anti-infective treatment. * Positive test for syphilis antibodies or human immunodeficiency virus (HIV) antibodies. * Subjects who are allergic to test drugs and excipients. * Women who are pregnant or breastfeeding. * Known drug or alcohol abuse. * Patients with mental or neurological diseases. * Prior allogeneic or autologous bone marrow transplantation or other solid organ transplantation. * Subjects who have a history of serious systemic disease or any other reason are not suitable to participate in this trial as judged by the investigator.
References
Publications (8)
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- BACKGROUNDZhu Y, An X, Zhang X, Qiao Y, Zheng T, Li X. STING: a master regulator in the cancer-immunity cycle. Mol Cancer. 2019 Nov 4;18(1):152. doi: 10.1186/s12943-019-1087-y. PMID 31679519
- BACKGROUNDLiu S, Cai X, Wu J, Cong Q, Chen X, Li T, Du F, Ren J, Wu YT, Grishin NV, Chen ZJ. Phosphorylation of innate immune adaptor proteins MAVS, STING, and TRIF induces IRF3 activation. Science. 2015 Mar 13;347(6227):aaa2630. doi: 10.1126/science.aaa2630. Epub 2015 Jan 29. PMID 25636800
- BACKGROUNDBarber GN. STING: infection, inflammation and cancer. Nat Rev Immunol. 2015 Dec;15(12):760-70. doi: 10.1038/nri3921. PMID 26603901
- BACKGROUNDAbe T, Barber GN. Cytosolic-DNA-mediated, STING-dependent proinflammatory gene induction necessitates canonical NF-kappaB activation through TBK1. J Virol. 2014 May;88(10):5328-41. doi: 10.1128/JVI.00037-14. Epub 2014 Mar 5. PMID 24600004
- BACKGROUNDRamanjulu JM, Pesiridis GS, Yang J, Concha N, Singhaus R, Zhang SY, Tran JL, Moore P, Lehmann S, Eberl HC, Muelbaier M, Schneck JL, Clemens J, Adam M, Mehlmann J, Romano J, Morales A, Kang J, Leister L, Graybill TL, Charnley AK, Ye G, Nevins N, Behnia K, Wolf AI, Kasparcova V, Nurse K, Wang L, Puhl AC, Li Y, Klein M, Hopson CB, Guss J, Bantscheff M, Bergamini G, Reilly MA, Lian Y, Duffy KJ, Adams J, Foley KP, Gough PJ, Marquis RW, Smothers J, Hoos A, Bertin J. Design of amidobenzimidazole STING receptor agonists with systemic activity. Nature. 2018 Dec;564(7736):439-443. doi: 10.1038/s41586-018-0705-y. Epub 2018 Nov 7. PMID 30405246
- Sivick KE, Desbien AL, Glickman LH, Reiner GL, Corrales L, Surh NH, Hudson TE, Vu UT, Francica BJ, Banda T, Katibah GE, Kanne DB, Leong JJ, Metchette K, Bruml JR, Ndubaku CO, McKenna JM, Feng Y, Zheng L, Bender SL, Cho CY, Leong ML, van Elsas A, Dubensky TW Jr, McWhirter SM. Magnitude of Therapeutic STING Activation Determines CD8+ T Cell-Mediated Anti-tumor Immunity. Cell Rep. 2019 Oct 15;29(3):785-789. doi: 10.1016/j.celrep.2019.09.089. No abstract available.