NCT06132217

A Study of Simmitinib Plus SG001 in Advanced Solid Tumors

A Phase I/II Study To Evaluate The Safety, Tolerability, Pharmacokinetic Profile And Preliminary Efficacy Of Simmitinib Plus SG001 in Patients With Advanced Solid Tumors

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 168 (estimated)
• Sponsor: Shanghai Runshi Pharmaceutical Technology Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label Phase I/II trial of simmitinib plus SG001 in patients with advanced solid tumors. Phase I will determine and confirm the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) for simmitinib in combination with SG001 in patients with advanced solid tumors. Phase 2 (Expansion) will evaluate the safety and efficacy of the combination in 3 cohorts at the RP2D from Phase I.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	Simmitinib	Patients will oral administration according to study protocol until disease progression, death, unacceptable toxicity, loss of follow-up, withdrawal of consent or other conditions meet the end of treatment criteria.
DRUG	SG001	Patients will receive intravenous infusion of SG001 according to study protocol until disease progression, unacceptable toxicity, meeting the suspension or termination criteria, or up to 24 months in patients without disease progression.

Timeline

• Start date: 2024-01-30
• Primary completion: 2027-01-30
• Completion: 2027-01-30
• First posted: 2023-11-15
• Last updated: 2023-11-15

Locations

1 site across 1 country: China