A Clinical Study to Evaluate the Safety and Tolerability of AWT020 in Patients With Advanced Malignancies

Required: PD-L1 (CD274) CPS ≥1 (CPS ≥1)

colorectal adenocarcinoma or rectal adenocarcinoma with histologically confirmed PD-L1 composite positive score [CPS] ≥1

Required: PD-L1 (CD274) CPS ≥1 (CPS ≥1)

Histologically confirmed PD-L1 CPS≥1 colorectal adenocarcinoma or rectal adenocarcinoma

Allowed: EGFR mutation

Subjects with EGFR or ALK mutations will need to progress with prior treatment with appropriate kinase inhibitors

Allowed: ALK fusion

Subjects with EGFR or ALK mutations will need to progress with prior treatment with appropriate kinase inhibitors

Allowed: MMR deficient mismatch repair

In patients with MSI-H/dMMR, previous treatment with PD-(L)1 inhibitors is permitted

Must have received: PD-(L)1 inhibitor — NSCLC, Melanoma, RCC, HCC

progressed after prior treatment with PD-(L)1 antibody

Must have received: platinum-based chemotherapy — NSCLC

progressed after prior treatment with...platinum-containing chemotherapy

Must have received: kinase inhibitor — NSCLC with EGFR or ALK mutations

Subjects with EGFR or ALK mutations will need to progress with prior treatment with appropriate kinase inhibitors

Must have received: chemotherapy — Melanoma

melanoma that has progressed after prior chemotherapy

Must have received: anti-angiogenesis targeted therapy — RCC, HCC

disease progression after previous treatment with targeted anti-angiogenesis therapy

Cannot have received: chemotherapy, immunotherapy, other anti-tumor therapy, investigational drugs

Exception: within 21 days before first dose

received chemotherapy, immunotherapy and other anti-tumor therapy or other investigational drugs within 21 days before the first dose

Cannot have received: oral fluorouracil, small molecule targeted drugs, Chinese medicines with anti-tumor indications

Exception: within 14 days before first dose

received oral fluorouracil, small molecule targeted drugs or Chinese medicines with anti-tumor indications within 14 days before the first dose

Cannot have received: major surgery or radiotherapy

Exception: within 28 days before first dose (palliative radiotherapy for local bone/brain lesions allowed within 14 days before 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)

Cannot have received: systemic corticosteroids (>10 mg prednisone per day or equivalent) or other immunosuppressants

Exception: for more than 1 week within 2 weeks prior to initial administration; inhaled or topical steroids or ≤10 mg/day systemic prednisone and equivalent doses allowed

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