The study will consist of a Phase I dose-escalation and Phase IIa dose-expansion component. Phase I dose-escalation phase will establish the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D),and evaluate the preliminary antitumor activity of HX111.
1. Able to understand and voluntarily sign the Informed Consent Form (ICF); 2. Male or female subject aged 18 to 70 years, inclusive. 3. Eastern Cooperative Oncology Group performance status of 0 to 1. 4. Life expectancy of ≥3 months; 5. Histologically confirmed advanced solid tumors (including sarcomas, head and neck squamous carcinoma, cervical cancer, breast cancer, etc.,) or advanced lymphomas (including peripheral T-cell lymphoma-not otherwise specified, Angioimmunoblastic T-cell Lymphoma, Extranodal Natural Killer/T-cell Lymphoma (nasal type), adult T-cell lymphoma/leukemia, Anaplastic Large Cell Lymphoma, and other EBV+ lymphomas) that is refractory/relapsed to standard therapies, or for which no effective standard therapy , or or for which the subject refuses standard treatment is available,.
Able to understand and voluntarily sign the Informed Consent Form (ICF);
Male or female subject aged 18 to 70 years, inclusive.
Eastern Cooperative Oncology Group performance status of 0 to 1.
1. Prior malignancy active within the previous 2 years except for the tumor for which a subject is enrolled in the study and locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix or breast.
Type I diabetes that is stable after a fixed dose of insulin or other hypoglycemic
Only requiring hormone replacement therapy for autoimmune hypothyroidism
Skin disease that does not require systemic treatment such as eczema, rash that accounts for <10% of the body surface, psoriasis without ophthalmic symptoms.
Single group
HX111 for injection
DrugHX111, 0.5-2.5mg/kg, once every 3 weeks
DLTs
rate of DLTs
ORR
rate of response
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