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ACTIVE NOT RECRUITING
NCT05076552
PHASE1

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

Sponsor: Tachyon Therapeutics, Inc.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2023-02-17

Completion Date

2025-07

Last Updated

2024-08-01

Healthy Volunteers

No

Interventions

DRUG

TACH101

Orally via capsules

Locations (8)

UCI Health

Orange, California, United States

Sarah Cannon Research Institute

Denver, Colorado, United States

Sarah Cannon Research Institute

Orlando, Florida, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

NEXT Oncology

Austin, Texas, United States

MD Anderson

Houston, Texas, United States

NEXT Oncology

San Antonio, Texas, United States

NEXT Oncology

Fairfax, Virginia, United States