NCT04780217

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

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: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: ImmVira Pharma Co. Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
BIOLOGICAL	T3011	T3011 will be administered through IV drip or pumping.

Timeline

• Start date: 2021-08-10
• Primary completion: 2025-03-01
• Completion: 2025-08-01
• First posted: 2021-03-03
• Last updated: 2024-03-04

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study