NCT05579275

Evaluate the Safety and Tolerability of JCXH-212 Monotherapy and Combined With Toripalimab in the Treatment of Malignant Solid Tumors

A Single-center, Open-label Study to Evaluate the Safety and Tolerability of JCXH-212 Monotherapy and Combined With Toripalimab in the Treatment of Malignant Solid Tumors

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Peking University Cancer Hospital & Institute · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and tolerability of JCXH-212 monotherapy and combined with Toripalimab in patients with malignant solid tumors; to determine the maximum tolerated dose (MTD), and to evaluate the dose-limiting toxicity (DLT) of JCXH-212 monotherapy and combined with Toripalimab.

Detailed description

This study uses 3+3 clinical design. About 12-24 patients with solid tumor malignancies are expected to be enrolled in this study. For JCXH-212 monotherapy, 2 dose groups are set for dose escalation (100μg, 200μg). Doses were administered every 21 days, with a DLT observation period of 21 days after the first dose. After completion of DLT assessment, the investigator decided whether to continue the treatment after the end of DLT assessment based on the subject 's tolerance and the safety profile of the dose group. Subjects may continue to receive dosing if the investigator determines that the subject is benefiting from continued treatment. No more than 8 total doses of JCXH-212 will be administered. For JCXH-212 combined with Toripalimab, 2 dose groups are set for dose escalation (100μg, 200μg of JCXH-212). JCXH-212 will be administered every 6 weeks, with a DLT observation period of 21 days after the first dose. Toripalimab (240mg per dose) will be administrated every 3 weeks. After completion of DLT assessment, the investigator decided whether to continue the treatment after the end of DLT assessment based on the subject 's tolerance and the safety profile of the dose group. Subjects may continue to receive JCXH-212 if the investigator determines that the subject is benefiting from continued treatment. No more than 8 total doses of JCXH-212 will be administered.

Conditions

• Malignant Solid Tumors

Interventions

Type	Name	Description
BIOLOGICAL	JCXH-212 Injection	Based on the development principle of NCV, a community-type tumor neoantigen mRNA vaccine, JCXH-212 injection, has been developed that can be applied to patients with malignant solid tumors. NCVs activate tumor-specific CD4+ T cells and CD8+ T cells through active immunity, and these T cells can inhibit and kill tumor cells in cancer patients, thus prolonging the survival of cancer patients.

Timeline

• Start date: 2023-02-06
• Primary completion: 2026-04-28
• Completion: 2027-04-28
• First posted: 2022-10-13
• Last updated: 2024-05-14

Locations

1 site across 1 country: China