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

Malignant Solid Tumors Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05579275
Study type Interventional
Source Peking University Cancer Hospital & Institute
Contact Zhuo Minglei, Physician
Phone 010-88196456
Email trialminglei@126.com
Status Recruiting
Phase Early Phase 1
Start date February 6, 2023
Completion date April 28, 2027
View Details
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