NCT05525455

TT-816 As Monotherapy or in Combination with a PD-1 Inhibitor in Patients with Advanced Cancers (SEABEAM) (MK3475-E88)

A Phase 1/2, First-in-human Study of the Safety, Pharmacokinetics, and Preliminary Anti-tumor Activity of TT-816 As Monotherapy or in Combination with a PD-1 Inhibitor in Patients with Advanced Cancers (SEABEAM) (MK3475-E88)

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Teon Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A first-in-human study using TT-816 as a single agent and in combination with a PD-1 inhibitor in advanced cancers.

Detailed description

This is an open-label, Phase 1/2, first-in-human (FIH), multiple ascending dose and dose-expansion study of TT-816 administered as monotherapy and in combination with a PD-1 inhibitor. Phase 1 will define the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of TT-816 and of combination therapy that can be advanced to Phase 2. Phase 2 will define the preliminary efficacy of these regimens in the setting of advanced solid tumors with high unmet medical needs including Non-Small Cell Lung Cancer (NSCLC), Ovarian Cancer and Renal Cell Carcinoma (RCC).

Conditions

• Advanced Cancer
• Advanced Solid Tumor
• Cancer
• Oncology

Interventions

Type	Name	Description
DRUG	TT-816	TT-816 is a novel, oral cannabinoid CB2 receptor antagonist acting as an immune checkpoint inhibitor for the treatment of a broad range of solid tumors
DRUG	A PD-1 inhibitor	Programmed death receptor-1 (PD 1)-blocking antibody

Timeline

• Start date: 2022-08-29
• Primary completion: 2023-09-07
• Completion: 2023-09-07
• First posted: 2022-09-01
• Last updated: 2024-11-21

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study