The purpose of this phase I clinical study was to evaluate the safety and tolerability of AWT020 monotherapy and combination with other antitumor therapies in patients with advanced malignancies
Both male and female subjects who are at least 18 years old at the time of signing the consent form;
Single-agent dose escalation and expansion phase to include patients with advanced malignant tumors who have failed or are intolerant of standard treatment, or have no standard treatment options;
NSCLC: histologically or cytologically confirmed, unresectable locally advanced, relapsed, or distant metastatic NSCLC that has progressed after prior treatment with PD-(L)1 antibody and platinum-containing chemotherapy (except after the last dose > Progression of adjuvant and neoadjuvant therapy within 6 months). Subjects with EGFR or ALK mutations will need to progress with prior treatment with appropriate kinase inhibitors.
Melanoma: histologically unresectable stage III or IV melanoma that has progressed after prior chemotherapy and treatment with PD-(L)1 inhibitors (except after the last dose > Adjuvant and neoadjuvant therapy that progresses within 6 months); Mucosal melanoma does not require prior PD-(L)1 inhibitor therapy.
received chemotherapy, immunotherapy and other anti-tumor therapy or other investigational drugs within 21 days before the first dose, or received oral fluorouracil, small molecule targeted drugs or Chinese medicines with anti-tumor indications within 14 days before the first dose;
Major surgery or radiotherapy within 28 days before the first dose (palliative radiotherapy for local bone/brain lesions allowed within 14 days before the first dose), coarse needle puncture biopsy or other minor surgery within 7 days before the start of study therapy, excluding placement of vascular infusion devices;
In combination therapy, patients who have been systematically treated with corticosteroids (> 10 mg prednisone per day or equivalent) or other immunosuppressants for more than 1 week within 2 weeks prior to initial administration are allowed to be treated with inhaled or topical steroids or ≤10 mg/ day systemic prednisone and equivalent doses of similar drugs;
There is active central nervous system metastasis. If the patient has received radiotherapy or surgery in the past, imaging examination within 4 weeks before the first medication indicates stable brain metastases without aggravation or new neurological symptoms, hormone therapy has been discontinued 2 weeks before the first medication, and screening is allowed; For meningeal and brainstem metastases, screening is not allowed regardless of treatment.