A Phase 1, Open-Label Study of ABSK021 to Assess Safety, Tolerability, and Pharmacokinetics in Patients With Advanced Solid Tumor
Status: Recruiting
Location: See all (17) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Histologically confirmed solid tumors that have progressed on or intolerant to standard therapy or whom no standard therapy exists
• ECOG (electrocorticogram) performance status 0\
‣ 1
• Life expectancy ≥ 3 months
• Adequate organ function and bone marrow function
‣ For patients with tenosynovial giant cell tumor (TGCT) :
⁃ A diagnosis of TGCT \[i ncluding pigmented villonodular synovitis (PVNS) or giant cell tumors of the tendon sheath (GCT TS) (i) that has been histologically confirmed either by a pathologist at the treating institution or a central pathologist, and (ii) where surgical resection would be associated with potentially worsening functional limitation or severe morbidity (locally advanced disease), with morbidity determined consensually by qualified personnel (eg, two surgeons or a multi disciplinary tumor board);
⁃ Measurable disease as defined by RECIST 1.1 (except that a minimal size of 2 cm is required), assessed from MRI scans;
⁃ Others
Locations
United States
California
Precision NextGen Oncology
RECRUITING
Beverly Hills
Colorado
SCRI at HealthOne
COMPLETED
Denver
Georgia
The Winship Cancer Institute of Emory University
COMPLETED
Atlanta
Texas
MD Anderson Cancer Center
COMPLETED
Houston
Other Locations
China
Beijing Jishuitan Hospital
RECRUITING
Beijing
West China Hospital of Sichuan University
RECRUITING
Chengdu
The First Affiliated Hospital of Sun Yat-sen University
RECRUITING
Guangdong
The Second Affiliated Hospital Zhejiang University School of Medicine
RECRUITING
Hangzhou
Jiangsu Province Hospital
ACTIVE_NOT_RECRUITING
Nanjing
Nanjing Drum Tower Hospital
RECRUITING
Nanjing
Huashan Hospital of Fudan University
COMPLETED
Shanghai
Shanghai Sixth People's Hospital
COMPLETED
Shanghai
Liaoning Cancer Hospital
COMPLETED
Shenyang
Hebei Medical University Third Hospital
COMPLETED
Shijiazhuang
Xi'an Hong Hui Hospital
RECRUITING
Xian
Henan Cancer Hospital
RECRUITING
Zhengzhou
The First Affiliated Hospital of Zhengzhou Universtity
COMPLETED
Zhengzhou
Contact Information
Primary
YUAN LU
clinical@abbisko.cn
+86-21-68910052
Backup
Siqing Fu, MD
siqingfu@mdanderson.org
(713)792-4318
Time Frame
Start Date:2020-01-20
Estimated Completion Date:2026-12-31
Participants
Target number of participants:276
Treatments
Experimental: ABSK021
Dose escalation of oral ABSK021 with a starting dose of 25mg once daily will be guided by3+3 escalation rules based on safety data until an MTD has been identified or a RDE. For each dose, patients will first receive a single dose ABSK021 tablet(s) by mouth at Day -3 and be followed by a 3-day off as a run-in period to access the safety and PK of single-dose. Then, patients will continuously receive ABSK021 once daily (QD) in repeated 28-day cycles.