NCT04301011

Study of TBio-6517 Given Alone or in Combination With Pembrolizumab in Solid Tumors

A Phase 1/2a, Multicenter, Open-label Trial of TBio-6517, an Oncolytic Vaccinia Virus, Administered Alone and in Combination With Pembrolizumab, in Patients With Advanced Solid Tumors

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Turnstone Biologics, Corp. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To determine the recommended Phase 2 dose (RP2D) of TBio-6517 when administered by direct injection into tumor(s) or intravenously and when combined with pembrolizumab in patients with solid tumors (RIVAL-01).

Detailed description

This is a Phase 1/2a dose escalation study with TBio-6517 administered by direct injection into tumor(s) or by intravenous infusion. The Phase 1 portion has 4 arms; the first arm (Arm A) will determine the RP2D of TBio-6517 alone when directly injected into tumor(s), and the second arm (Arm B) will determine the RP2D of TBio-6517 when combined with pembrolizumab. The third and fourth arms will determine the RP2D of TBio-6517 when given intravenously alone and with pembrolizumab, respectively. In the Phase 2a portion, the clinical benefit of TBio-6517 combined with pembrolizumab will be further explored in patients with Microsatellite Stable Colorectal Cancer (MSS-CRC), Cholangiocarcinoma (CCA), Cutaneous Melanoma, and Cutaneous Squamous Cell Carcinoma of the Skin (cSCC), as assessed by overall response rate (ORR) from central radiology review.

Conditions

• Solid Tumor
• Microsatellite Stable Colorectal Cancer
• HPV Positive Oropharyngeal Squamous Cell Carcinoma
• Cervical Cancer
• Melanoma (Skin)
• Cutaneous Squamous Cell Carcinoma
• Mesothelioma
• Renal Cell Carcinoma
• Oropharynx Cancer

Interventions

Type	Name	Description
BIOLOGICAL	TBio-6517	Engineered Oncolytic Vaccinia Virus
BIOLOGICAL	Pembrolizumab	Immune checkpoint inhibitor.

Timeline

• Start date: 2020-06-02
• Primary completion: 2023-01-23
• Completion: 2023-01-23
• First posted: 2020-03-09
• Last updated: 2025-04-23

Locations

11 sites across 3 countries: United States, Canada, South Korea

Regulatory

• FDA-regulated drug study