This is a multicenter, single-arm, open-label, dose-escalation, dose-expansion study to evaluate the safety, tolerability, PK/PD, and preliminary anti-tumor activity of GH56 Capsule in subjects with advanced solid tumors who have failed or are intolerant in standard treatment, or have no standard therapy. The clinical trial will be carried out in two parts: phase Ia study (dose escalation study) and phase Ib (dose expansion study).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
90
GH56 capsule for oral administration at specified doses on scheduled days.
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
RECRUITINGShanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, China
NOT_YET_RECRUITINGShanghai GoBroad Caner Hospital China Pharmaceutical University
Shanghai, Shanghai Municipality, China
1. Determination of Maximum Tolerated Dose (MTD) , RDEs of GH56.
MTD is the highest dose of a treatment that does not cause unacceptable side effects. RDEs stand for Recommended Dose for Expansion.
Time frame: Approximately 3 years
Characterize the Safety of GH56
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
Cmax
The maximum or "peak" concentration of GH56 observed after administration
Time frame: Approximately 3 years
Tmax
The time to peak concentration of GH56
Time frame: Approximately 3 years
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Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, China
NOT_YET_RECRUITINGT1/2
Half-life of GH56
Time frame: Approximately 3 years
PD of GH56
Change of sDMA protein expression in tumor tissues
Time frame: Approximately 3 years