Evaluate the safety and tolerability of GH21 in patients with advanced solid tumors. Estimate the maximum tolerated dose (MTD) in patients with advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
68
GH21 for oral administration at doses of Dose A, Dose B, Dose C, Dose D, Dose E and Dose F.
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
RECRUITINGCancer Hospital Chinese Academy of Medical Science
Beijing, Beijing Municipality, China
RECRUITINGDetermination of Maximum Tolerated Dose (MTD) of GH21.
MTD is the highest dose of a treatment that does not cause unacceptable side effects.
Time frame: 28 Days
Characterize the Safety of GH21
Number of participants with treatment-emergent adverse events and serious AEs.
Time frame: Approximately 3 years
Objective Response Rate (ORR)
Based on assessment of radiographic imaging per RECIST version 1.1
Time frame: Approximately 3 years
Disease Control Rate (DCR)
Based on assessment of radiographic imaging per RECIST version 1.1
Time frame: Approximately 3 years
Duration of Response (DOR)
Based on assessment of radiographic imaging per RECIST version 1.1
Time frame: Approximately 3 years
Progression-Free Survival (PFS)
Based on assessment of radiographic imaging per RECIST version 1.1
Time frame: Approximately 3 years
PD of GH21
Change of phosphorylated ERK
Time frame: Approximately 3 years
Cmax
The maximum or "peak" concentration of GH21 observed after administration
Time frame: Approximately 3 years
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Beijing University Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGChongqing Cancer Hospital
Chongqing, Chongqing Municipality, China
RECRUITINGHenan Cancer Hospital
Zhengzhou, Henan, China
RECRUITINGThe First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
RECRUITINGNanjing Drum Tower Hospital
Nanjing, Jiangsu, China
RECRUITINGThe First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China
RECRUITINGTaizhou Hospital of Zhejiang Province
Linhai, Zhejiang, China
RECRUITINGTmax
The time to peak concentration of GH21
Time frame: Approximately 3 years
T1/2
Half-life of GH21
Time frame: Approximately 3 years