NCT06621615

Clinical Study of CVL006 Injection in Advanced Solid Tumors

An Open Label, Multicenter Phase I Clinical Study on the Safety, Tolerability, Pharmacokinetics, and Efficacy of CVL006 Injection in Patients With Advanced Solid Tumors.

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Convalife (Shanghai) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Evaluate the safety and tolerability of CVL006 monotherapy in patients with advanced solid tumors; Observe the dose limiting toxicity (DLT) of CVL006 monotherapy in patients with advanced solid tumors, evaluate the maximum tolerated dose (MTD), and recommend the dosage for phase II clinical trials (RP2D).

Detailed description

This study is a phase I clinical trial of single arm, open label, multicenter dose escalation/dose extension/efficacy extension. The research process for each dose group includes a screening period (from the signing of the informed consent form by the subjects to 1 day before the first study medication), a medication period (from the first study medication to termination of medication), and a follow-up period (90 days after termination of medication). This study is divided into three stages: I. Dose escalation stage: Accelerated titration combined with a "3+3" design is used to dose up CVL006 injection. Accelerated titration is preset with three doses, starting at 0.03 mg/kg. Only one subject is enrolled in each dose group. After completing the three preset doses, four dose groups are designed according to the "3+3" principle, with 3-6 subjects enrolled in each dose group, up to a maximum of 42 subjects enrolled. Ib. Dose extension stage: Based on the observed safety, tolerability, efficacy, and PK characteristics during the dose escalation process, in the dose group where a certain therapeutic effect is observed in the subjects (such as 1 PR/CR or 2 SD), the SMC meeting will decide whether to extend the dose in that dose group. Plan to expand each dose group by no more than 10 subjects (including subjects with the same dose during the dose escalation phase). And determine RP2D based on data from dose escalation and expansion stages. Ic. Efficacy expansion stage: RP2D was selected for expansion, with each tumor type expanded to 10-30 cases. This study is expected to enroll approximately 100-120 cases, depending on the actual situation. Dose escalation, dose expansion, and efficacy expansion are the same: CVL006 injection, intravenous infusion, once every 2 weeks, every 28 days as a cycle. The subsequent administration time is calculated based on the actual date of the previous CVL006 administration. SMC can adjust the dosing frequency based on safety, tolerability, and PK results data.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
BIOLOGICAL	CVL006 Injection	CVL006 injection, intravenous infusion, administered every 2 weeks. Every 28 days is a cycle. Until the subject cannot tolerate the disease progression or toxicity, or the researcher determines that the medication must be terminated or the sponsor terminates the study. SMC can adjust the dosing frequency based on safety, tolerability, and PK results data. If researchers consider that subjects enrolled in the lower dose group can benefit from the study intervention, they can allow them to continue treatment at a higher dose that has been proven safe based on the researcher's judgment.

Timeline

• Start date: 2024-11-20
• Primary completion: 2028-05-20
• Completion: 2028-11-20
• First posted: 2024-10-01
• Last updated: 2024-10-01