Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-25 @ 9:16 PM
Study NCT ID:
NCT07157956
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-05
First Post:
2025-08-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
CVL006 Combination Therapy in Advanced Solid Tumors
Sponsor:
Convalife (Shanghai) Co., Ltd.
Organization:
Study Overview
Official Title:
Phase I/II Clinical Study of CVL006 Combination Therapy in Advanced Solid Tumors
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CVL006-T1002
Brief Summary:
This study is a multi-center, open-label, dose-escalation and dose-optimized phase I/II clinical trial. Objective: To determine the safety, tolerability, PK characteristics and preliminary efficacy data of CVL006 combined with pemetrexed + carboplatin/SKB264/ DS-8201a/ Enfortumab Vedotin in patients with advanced solid tumors.
Detailed Description:
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).
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).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: