Spots Global Cancer Trial Database for Evaluate the Safety and Tolerability of JCXH-212 Monotherapy and Combined With Toripalimab in the Treatment of Malignant Solid Tumors

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Trial Identification

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

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

Study ID: NCT05579275

Conditions

Malignant Solid Tumors

Interventions

JCXH-212 Injection

Study Description

Brief 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.