NCT05076552

A Study to Assess the Safety, Pharmacokinetics, and Antitumor Activity of Oral TACH101 in Participants With Advanced or Metastatic Cancer

A Phase 1a/1b Open-label Study to Assess the Safety, Pharmacokinetics, and Antitumor Activity of Oral TACH101 in Patients With Advanced or Metastatic Solid Tumors

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Tachyon Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main objective for part 1a of the study is to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) and to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of oral TACH101 in participants with advanced and metastatic solid tumors. For part 1b, the main objective is the objective response rate (ORR) as assessed by radiographic progression measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

Conditions

• Advanced Cancer
• Metastatic Solid Tumor
• Solid Tumor

Interventions

Type	Name	Description
DRUG	TACH101	Orally via capsules

Timeline

• Start date: 2023-02-17
• Primary completion: 2025-07-01
• Completion: 2025-07-01
• First posted: 2021-10-13
• Last updated: 2024-08-01

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study