Intravenous T3011 Given as a Single Agent and in Combination With Other Therapy in Subjects With Advanced Solid Tumors

Colorectal Cancer Clinical Trial

Official title: A Phase 1/2a Open-Label Dose Escalation and Dose Expansion Study of T3011 When Administered Intravenously as a Single Agent and in Combination With Other Therapy in Subjects With Advanced Solid Tumors

Status Active, not recruiting

Clinical Trial Summary

A Phase 1/2a Open-Label Dose Escalation and Dose Expansion Study of T3011 when Administered Intravenously as a Single Agent and in Combination with Other Therapy in Subjects with Advanced Solid Tumors

Clinical Trial Description

This is a multicenter, open-label study conducted in two phases (as outlined in the subsections below):

Phase 1: T3011 administered intravenously as a single agent in subjects with pathologically confirmed locally recurrent or metastatic solid tumors, who have failed or declined SOC treatment. Phase 1 will use a 3+3 design to evaluate escalating doses of single agent T3011. Cohorts of three subjects will be enrolled at each T3011 dose level with expansion to six subjects, if necessary, to assess toxicity. Total enrollment will depend on the toxicities observed, with approximately 36-42 evaluable subjects enrolled in phase 1.

Phase 2a: An expansion study will be conducted based on phase 1 results. ;

Related Conditions & MeSH terms

• Colorectal Cancer
• Endometrial Cancer
• Endometrial Neoplasms
• Hepatocellular Carcinoma
• NSCLC
• Ovarian Cancer
• Solid Tumor

• NCT number: NCT04780217
• Study type: Interventional
• Source: ImmVira Pharma Co. Ltd
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: August 10, 2021
• Completion date: August 2025