NCT06682611

Safety and Efficacy of SYHA1813 Single Agent or in Combination With Different Regimens in Unresectable Locally Advanced or Metastatic Solid Tumors.

An, Phase Ib/II Clinical Trial to Evaluate the Safety and Efficacy of SYHA1813 Single Agent or in Combination With Different Regimens in Unresectable Locally Advanced or Metastatic Solid Tumors.

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 380 (estimated)
• Sponsor: Shanghai Runshi Pharmaceutical Technology Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, multi-center, multi-cohort, phase Ib/II clinical trial, divided into 8 cohorts according to tumor types. Cohorts 1-4 are SYHA1813 combined with different regimens, including safety run-in stage and cohort expansion stage. Cohorts 5-8 are SYHA1813 monotherapy and only include the expansion cohorts. The primary objective was to evaluate the safety and efficacy of SYHA1813 single agent or in combination with different regimens in unresectable locally advanced or metastatic solid tumors.

Detailed description

In the safety run-in stage, the "3+3" design is used to evaluate the tolerability and safety of different dose levels combined with different regimens, and the observation period of DLT is set as the first treatment cycle. After 3 DLT-evaluable participants at each dose level completed the DLT observation period, the safety of the dose level is evaluated by an SMC consisting of the investigator and the sponsor's medical monitor. Cohorts 1-4 enter the cohort expansion stage after determining the SYHA1813 dose regimen during the safety run-in stage. Cohorts 5-8 enter the cohort expansion stage directly. In the expansion stage, cohorts 1-6 are single-arm studies, the primary endpoint is ORR as evaluated by investigator according to RECIST 1.1. Cohorts 7-8 are randomized controlled studies, the primary endpoint is PFS as evaluated by investigator according to RECIST 1.1.

Conditions

• Unresectable Locally Advanced or Metastatic Solid Tumors

Interventions

Type	Name	Description
DRUG	SYHA1813	In accordance with the protocol
DRUG	SG001	In accordance with the protocol
DRUG	HB1801	In accordance with the protocol
DRUG	Carboplatin	In accordance with the protocol
DRUG	Cisplatin	In accordance with the protocol
DRUG	Paclitaxel	In accordance with the protocol
DRUG	Etoposide	In accordance with the protocol
DRUG	Everolimus	In accordance with the protocol
DRUG	Regorafenib	In accordance with the protocol

Timeline

• Start date: 2024-11-13
• Primary completion: 2026-11-13
• Completion: 2027-11-13
• First posted: 2024-11-12
• Last updated: 2024-11-12