Title: An Exploratory Study of A-337 in the Management of Malignant Solid Dose Escalation and Expansion Phases
18-75 years, all genders
Patients with histologically or cytologically confirmed advanced malignant solid tumors who have failed standard treatment, have no standard treatment options, or are not suitable for standard treatment at this stage.
The interval between the first dose of investigational drug and previous major surgery, medical device treatment, or local radiotherapy was at least 28 days. At least 21 days between the first dose of investigational drug and previous cytotoxic chemotherapy, immunotherapy, or biological agents; At least 14 days between he first dose of investigational drug and previous tumor-related endocrinotherapy and minor surgery; The interval between he first dose of investigational drug and small molecule targeted drugs was at least 21 days or 5 half-lives, whichever is longer; At least 14 days interval between the first dose of investigational drug and antineoplastic chinese traditional medicines.
Patients with at least one measurable lesion on the basis of RECIST v1.1.
Past or present malignant tumor diagnosed in the past 3 years and/or required treatment.Except for the completely resected basal and squamous cell skin cancers and any type in situ.
Patients with CNS metastases, unless the metastases were treated and stable for at least 4 weeks and without taking systemic steroids ≥ 10 mg prednisone/day or equivalent.
Patients with HIV
Patients requiring systemic or local treatment with systemic steroids or any immunomodulatory drug (at a level that results in a systemic dose effect).E.g. High-dose oral or intravenous steroids > 10 mg/ day prednisone or its equivalent, or methotrexate > 15 mg once weekly).Allow topical, inhaled or topical use of steroids (at levels not thought to cause systemic dose effects);
Single group
Recombinant Anti-EpCAM-CD3 Antibody Injection
Biological/VaccineIntravenous Infusion
Evaluate the Incidence and Characteristics of Adverse Events of A-337 in the Treatment of malignant Solid Tumors
Incidence and characteristics of adverse events
Evaluate the MTD and DLT of A-337 in the Treatment of malignant Solid Tumors
dose limited toxicity(DLT), maximum tolerance dose(MTD)
Evaluate the PK(Cmax) of A-337 in the Treatment of malignant Solid Tumors
Cmax
Evaluate the PK(Tmax) of A-337 in the Treatment of malignant Solid Tumors
Tmax
Evaluate the PK（T1/2) of A-337 in the Treatment of malignant Solid Tumors
T1/2
Evaluate the PK(Vd) of A-337 in the Treatment of malignant Solid Tumors
Vd
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