The purpose of this study is to evaluate the anti-tumor activity of ABSK061 + ABSK043 in terms of overall response rate (ORR) in in Patients with Metastatic/Unresectable Solid Tumors with FGFR2/3 Alterations
ABSK061 is a selective and potent pan FGFR 2/3 inhibitor with demonstrated clinical activity in participants with a variety of FGFR inhibitors in a variety of solid tumors. ABSK043 is a small molecule PD-L1 inhibitor with good oral bioavailability, high selectivity and high activity, and is currently being developed for the treatment of multiple cancers and potential non-oncology indications. This study targets the underlying altered biology of FGFR-driven tumors irrespective of solid tumor histology subtype. The study consists of screening phase, treatment phase and the post treatment follow-up phase (from the end of treatment visit until the participant has died, withdraws consent, is lost to follow-up, or the end of study, whichever comes first). End of study is considered of the last visit of the last patient in this trial or the procedures shown in the schedule, or 12 months after the first dose of the last enrolled patient, whichever occurs first.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
202
Participants with fibroblast growth factor receptor (FGFR) mutations and FGFR gene fusions will receive a dose of ABSK061 + ABSK043 oral capsule until disease progression, intolerable toxicity, withdrawal of consent, decision by the investigator to discontinue treatment, or end of data collection timepoint if there is clinical benefit in the opinion of the investigator, has been achieved.
Participants with HER2-Gastric/Gastroesophageal Junction Cancer and fibroblast growth factor receptor 2( FGFR2 ) amplification and overexpression will receive a dose of ABSK061 + ABSK043 oral capsule in combination with CAPOX until disease progression, intolerable toxicity, withdrawal of consent, decision by the investigator to discontinue treatment, or end of data collection timepoint if there is clinical benefit in the opinion of the investigator, has been achieved.
Guizhou Provincial People'S Hospital
Guiyang, Guizhou, China
Incidence of Dose limited toxicity (DLT)
Number of Participants With Adverse Event (AE), Serious Adverse Event, (SAE) and Laboratory Abnormalities Defined as Dose Limiting Toxicities (DLT)
Time frame: At the end of Cycle 1 (each cycle is 28 days)
To assess the tolerability of ABSK061 + ABSK043 in combination with CAPOX in patients with first-line gastric/gastroesophageal junction cancer
Number of Participants With Adverse Event (AE), Serious Adverse Event, (SAE) and Laboratory Abnormalities Defined as Dose Limiting Toxicities (DLT)
Time frame: At the end of Cycle 1 (each cycle is 21 days)
To assess the anti-tumor activity of ABSK061 + ABSK043 in combination with CAPOX as the primary endpoint of Progression-free survival (PFS) in first-line treatment of patients with metastatic/unresectable HER2-gastric/gastroesophageal junction cancer
PFS, as assessed by the investigator per RECIST v1.1
Time frame: up to 5 years
To assess the anti-tumor activity of ABSK061 + ABSK043 in patients with metastatic/unresectable urothelial cancer with FGFR2/3 activating alteration or FGFR3 overexpression, with Objective response rate (ORR) as the primary endpoint
Objective response rate (ORR): complete response and partial response determined by the investigator according to RECIST v1.1 and to be confirmed
Time frame: up to 5 years
To assess the anti-tumor activity of ABSK061 + ABSK043 in patients with non-small cell lung cancer withFGFR2/3 activating alteration or overexpression as the primary endpoint
PFS, as assessed by the investigator per RECIST v1.1
Time frame: up to 5 years
To assess the anti-tumor activity of ABSK061 + ABSK043 in patients with metastatic/unresectable other advanced solid tumors with FGFR2/3 activatingon alteration or overexpression as the primary endpoint
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The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
NOT_YET_RECRUITINGThe Fourth Hospital of Hebei Medical University
Shijiazhuang, Heibei, China
NOT_YET_RECRUITINGHarbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
NOT_YET_RECRUITINGHenan Cancer Hospital
Zhengzhou, Henan, China
NOT_YET_RECRUITINGHunan Central Hospital
Changsha, Hunan, China
NOT_YET_RECRUITINGJiangxi Cance Hospital
Nanchang, Jiangxi, China
NOT_YET_RECRUITINGLiaoning Cancer Hospital and Institute
Shenyang, Liaoning, China
NOT_YET_RECRUITINGCancer Hospital of Shandong First Medical University
Jinan, Shandong, China
NOT_YET_RECRUITINGZhongShan Hospital Fudan University
Shanghai, Shanghai Municipality, China
RECRUITING...and 11 more locations
Objective response rate (ORR): complete response and partial response determined by the investigator according to RECIST v1.1 and to be confirmed
Time frame: up to 5 years
Overall Response Rate as Assessed by Investigator
Objective response rate (ORR): complete response and partial response determined by the investigator according to RECIST v1.1 and to be confirmed
Time frame: Up to 5 years
Duration of Response (DOR)
DOR is the duration from the date of initial documentation of a response to the date of first documented evidence of progressive disease (or relapse for participants who experience CR during the study), or death, whichever comes first.
Time frame: Up to 5 years
Disease Control Rate (DCR)
DCR is defined as the percentage of participants with CR, PR or stable disease (SD).DCR is defined as the percentage of participants with CR, PR or stable disease (SD).
Time frame: up to 5 years
Progression Free Survival (PFS)
PFS is the duration from the date of the first dose of study drug until the date of first documented evidence of progressive disease (or relapse for participants who experience CR during the study) or death, whichever comes first.
Time frame: up to 5 years
Overall Survival (OS)
OS will be measured from the date of first dose of study drug to the date of the participant\'s death.
Time frame: up to 5 years
Maximum observed concentration(Cmax)
To assess the PK profile of ABSK061 and ABSK043 after dosing of ABSK061 + ABSK043
Time frame: From date of enrollment #Day1# until the date of end of treatment visit, assessed up to 12 months
Area under the concentration-time curve(AUC)
To assess the PK profile of ABSK061 and ABSK043 after dosing of ABSK061 + ABSK043
Time frame: From date of enrollment #Day1# until the date of end of treatment visit, assessed up to 12 months
Time to maximum observed concentration(Tmax)
To assess the PK profile of ABSK061 and ABSK043 after dosing of ABSK061 + ABSK043
Time frame: From date of enrollment #Day1# until the date of end of treatment visit, assessed up to 12 months