Zhaoke (Guangzhou) Oncology Pharmaceutical Ltd.

Primary purpose: This study mainly uses melphalan tablets provided by Zhaoke (Guangzhou) Oncology Drug Co., Ltd. as the test preparation, and the original drug ALKERAN® (melphalan) produced by Excella GmbH & Co KG as the reference preparation according to the relevant regulations of bioequivalence studies. The pharmacokinetic characteristics of the two preparations in Chinese cancer patients are evaluated. Secondary research objectives: To evaluate the safety of oral melphalan tablets test preparations and reference preparations in Chinese cancer patients.

Main objectives: Phase Ib: To evaluate the safety and Phase II recommended dose (RP2D) of Pexa-Vec combined with ZKAB001 in patients with locally advanced or metastatic melanoma who have failed first-line treatment; Phase II: To evaluate the objective response rate (ORR) and progression-free survival (PFS) of ZKAB001 combined with Pexa-Vec Phase II recommended dose or ZKAB001 monotherapy in patients with locally advanced or metastatic melanoma who have failed first-line treatment. Secondary objectives: 1) To evaluate the overall survival (OS), disease control rate (DCR) and duration of response (DOR) of patients with locally advanced or metastatic melanoma who have failed first-line treatment with ZKAB001 combined with Pexa-Vec and ZKAB001 alone; 2) To evaluate the safety of Pexa-Vec combined with ZKAB001 in patients with locally advanced or metastatic melanoma who have failed first-line treatment; 3) To evaluate the relationship between the expression level of PD-L1 in tumor tissue and clinical effect; 4) To evaluate the changes in the immune microenvironment of tumor tissue before and after Pexa-vec treatment (CD8+ expression level).

To evaluate the objective response rate (ORR) of gimatidecan capsules in the treatment of platinum-resistant relapsed/refractory epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, as evaluated by an independent imaging review committee (IRC) using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST V1.1).