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A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ABSK-021 in Patients With Advanced Solid Tumor

Status
Active
Cancer Type
Solid Tumor
Unknown Primary
Trial Phase
Phase I
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT04192344
Protocol IDs
ABSK021-101 (primary)
NCI-2020-05560
Study Sponsor
Abbisko Therapeutics Co, Ltd

Summary

This is an open-label phase 1 study to determine the safety and tolebility of oral ABSK021 in
patients with advanced solid tumor as well as the Recommended Phase 2 dose (RP2D) of oral
ABSK021. Preliminary antitumor activity will also be assessed.

Objectives

The study will start with a dose escalation part of single-agent ABSK021 administered in
repeated 28-day cycles in patients with advanced solid for safety and tolerability. The
expansion part of oral ABSK021 at recommended dose of expansion (RDE) will be followed for
further evaluating safety and tolerability among selected tumor types. Preliminary antitumor
activity will also be assessed.

Eligibility

  1. Histologically confirmed solid tumors that have progressed on or intolerant to standard therapy or whom no standard therapy exists
  2. ECOG (electrocorticogram) performance status 0~1
  3. Life expectancy = 3 months
  4. Adequate organ function and bone marrow function

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
Georgia CORE

 

Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.