CVL006 Combination Therapy in Advanced Solid Tumors

1. Phase I Arm1.1 - Arm1.4: Dose escalation of CVL006 combined with pemetrexed + carboplatin/SKB264/ DS-8201a/ Enfortumab Vedotin: Dose escalation studies of CVL006 combined with pemetrexed + carboplatin/SKB264/DS-8201a/ Enfortumab Vedotin can be conducted simultaneously, with two dose groups preset for each combination: The starting Dose (Dose Level1 \[DL1\]) of CVL006 is 3mg/kg or more (the investigator and the sponsor can discuss and decide on a dose of 3mg or more based on more data from the Phase I monotherapy study), Q2W or Q3W administration, and DL2 (one dose group higher than DL1) dose. Arm1.1 to Arm1.4 Each cohort is expected to increase to 6 to 12 subjects. Based on the data such as safety, tolerability, efficacy and PK characteristics observed during the dose escalation process of each cohort, the researcher and the sponsor jointly decided whether to adopt the Backfill design, that is, to enroll additional patients in the confirmed safe low-dose group during the dose escalation process. And decide whether to explore other administration doses or frequencies (such as Q3W). 2. Phase II Dose optimization study In order to further evaluate the PK characteristics, safety and preliminary anti-tumor activity of CVL006 combined with pemetrexed + carboplatin/SKB264/ DS-8201a/ Enfortumab Vedotin, while the dose escalation trial of phase I was being conducted, Several dose groups that have passed the safety assessment during the DLT observation period will be selected to conduct the Phase II dose expansion study simultaneously. If, based on the obtained safety, tolerability, PK and efficacy information, the investigator and the sponsor discuss and decide on the choice of dose expansion and the specific number of cases to be increased. And whether a new dose needs to be added for dose expansion. Similarly, for each cohort with a new dose or a new administration frequency, the number of subjects in each group should be increased to 8-30 (subjects who previously used the same dose can be included).