Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Male or female, aged ≥ 18 years
Have advanced histologically or cytologically confirmed solid tumor
Have progressed on after treatment with standard therapies or intolerant of standard care
At least 1 unidimensional measurable target lesion per RECIST v1.1
Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1
Have life expectancy of at least 12 weeks based on investigator's judgement

Exclusion Criteria:

Treated with any investigational drug within 4 weeks prior to the fist dose of study drug
Received any anticancer therapy less than 28 days prior to the first administration of study drug or within 5 half-lives of the therapy agent, whichever is shorter. Prior palliative radiotherapy to bone metastases ≤ 2 weeks prior to the first dose of YH001 is acceptable
Subjects with prior anti-CTLA-4 checkpoint inhibitors should be excluded
Subjects with prior PD-1/L1 treatment intolerate to PD-1/L1 therapy should be excluded
Subjects with a history of ≥ Grade 3 immune-related adverse events (AEs) resulted from previous immunotherapy or an AE of any grade that resulted in discontinuation of prior immunotherapy
Subjects with a history of ≥ Grade 2 pneumonitis resulted from previous immunotherapy or with a SpO2 by pulse oximetry < 92% at the screening
Subjects requiring systemic treatment with corticosteroids (>10 mg/day prednisone or equivalent) or other immunosuppressive medications within 21 days before the planned first dose of study drug or has need to be treated while on trial. Inhaled or topical steroids, and adrenal replacement steroid doses ≤ 10 mg daily prednisone equivalent are permitted in the absence of active autoimmune disease. Ophthalmologic, nasal and intra-articular injections of steroids are allowed
Subjects with concomitant active autoimmune disease, history of autoimmune disease requiring systemic treatment, or history of autoimmune disease within the two years prior to study entry. Exceptions are subjects with vitiligo, resolved childhood asthma/atopy, type I diabetes mellitus or hypothyroidism which can be managed by replacement therapy
Primary central nervous system (CNS) malignancies or symptomatic CNS metastases. But subjects with asymptomatic CNS metastases might be eligible if they have no clinical evidence of progression since completion of CNS-directed therapy, minimum 4 weeks between completion of radiotherapy and the first dose of YH001 and are currently not receiving corticosteroids
QTc > 450 ms at baseline; no concomitant medications that would prolong the QT interval; no family history of long QT syndrome
Continuance of toxicities due to prior radiotherapy or chemotherapy agents that have not recovered to ≤ Grade 1 per CTCAE v5.0, except alopecia, < Grade 2 sensory neuropathy