| Primary | Phase Ib: Patients With Event(s) of Dose-limiting Toxicity | Number of DLT (Dose-limiting toxicity) During the Administration of BLU-554 in Combination with CS1001. All toxicity or adverse events (AEs) are graded according to NCI-CTCAE 5.0. Any AE occurring during C1 (21 days) that is not clearly caused by something other than investigational drug. | Fisogatinib (BLU-554) 600mg arm, 7 subjects were enrolled, of whom 6 completed DLT evaluation and 1 was unevaluable | Posted | | Count of Participants | | Participants | | Cycle 1 (21 days) of treatment | | | | ID | Title | Description |
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| OG000 | Phase Ib: Fisogatinib (BLU-554) 400mg in Combination With Sugemalimab (CS1001) 1200mg | Phase Ib: participants received 400 mg Fisogatinib (BLU-554) once daily (QD), in combination with 1200mg fixed dose Sugemalimab (CS1001) once every 3 weeks (Q3W). Every 21 days (3 weeks) will be considered as one cycle. | | OG001 | Phase Ib: Fisogatinib (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg | Phase Ib: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle. |
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| Primary | Phase Ib: Safety and Tolerance | An AE was any untoward medical occurrence after clinical study subjects receive study drug. An SAE was any event that meets any the following criteria: death, life-threatening; inpatient hospitalization or prolongation, persistent or significant disability/incapacity;congenital malformation/birth defects and significant medical events. AE and SAE were graded by CTCAE version 5.0 by severity, from Grade 1 mild to Grade 5 death related AE. | Baseline Analysis Population consists of all participants receiving at least one dose of investigational product | Posted | | Count of Participants | | Participants | | Safety and tolerance assessments continued for the duration of treatment. AEs and SAEs will be collected from time of signature of main informed consent, throughout the treatment period and including the follow-up period, up to approximate 22 months. | | | | ID | Title | Description |
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| OG000 | Phase Ib: Fisogatinib (BLU-554) 400mg in Combination With Sugemalimab (CS1001) 1200mg | Phase Ib: participants received 400 mg Fisogatinib (BLU-554) once daily (QD), in combination with 1200mg fixed dose Sugemalimab (CS1001) once every 3 weeks (Q3W). Every 21 days (3 weeks) will be considered as one cycle. | | OG001 | Phase Ib: Fisogatinib (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg | Phase Ib: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle. |
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| Primary | Phase II: Objective Response Rate (ORR) Assessed by Investigator Based on RECIST Version 1.1 | Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1 .1) for target lesions and assessed by MRI/ CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), > =30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR. Percentage of subjects who achieve objective tumor response (CR or PR) will be summarized. | | Posted | | Count of Participants | | Participants | | Imaging (CT or MRI) assessments per RECIST v1.1 will be performed within 28 days prior to the first dose (baseline assessment), every 9 weeks during the first year of the study, and every 12 weeks thereafter. Up to 22 months. | | | | ID | Title | Description |
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| OG000 | Phase II: Fisogatinib (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg | Phase II: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle. |
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| Secondary | Disease Control Rate Assessed by Investigator | Disease control rate (DCR) is defined as the proportion of participants who achieve complete response (CR), partial response (PR), and stable disease (SD) based on Response Evaluation Criteria In Solid Tumors (RECIST)v1.1. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1 .1) for target lesions and assessed by MRI/ CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), > =30% decrease in the sum of the longest diameter of target lesions. Stable disease(SD) is defined as a tumor that does not meet the criteria for progression or for response. | | Posted | | Count of Participants | | Participants | | Imaging (CT or MRI) assessments per RECIST v1.1 will be performed within 28 days prior to the first dose (baseline assessment), every 9 weeks during the first year of the study, and every 12 weeks thereafter. Up to 22 months. | | | | ID | Title | Description |
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| OG000 | Phase Ib: Fisogatinib (BLU-554) 400mg in Combination With Sugemalimab (CS1001) 1200mg | Phase Ib: participants received 400 mg Fisogatinib (BLU-554) once daily (QD), in combination with 1200mg fixed dose Sugemalimab (CS1001) once every 3 weeks (Q3W). Every 21 days (3 weeks) will be considered as one cycle. | | OG001 | Phase Ib: Fisogatinib (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg | Phase Ib: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle. |
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| Secondary | Duration of Response Assessed by Investigator | Duration of response for responders (CR or PR) is defined as the time interval between the date of the earliest qualifying response and the date of PD or death for any cause (whichever occurs earlier). For subjects who are alive without progression following the qualifying response, duration of response will be censored on the date of last evaluable tumor assessment or last follow-up for progression of disease. | Only include participants with confirmed response (CR or PR). | Posted | | Median | 95% Confidence Interval | Months | | Imaging (CT or MRI) assessments per RECIST v1.1 will be performed within 28 days prior to the first dose (baseline assessment), every 9 weeks during the first year of the study, and every 12 weeks thereafter. Up to 22 months. | | | | ID | Title | Description |
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| OG000 | Phase Ib: Fisogatinib (BLU-554) 400mg in Combination With Sugemalimab (CS1001) 1200mg | Phase Ib: participants received 400 mg Fisogatinib (BLU-554) once daily (QD), in combination with 1200mg fixed dose Sugemalimab (CS1001) once every 3 weeks (Q3W). Every 21 days (3 weeks) will be considered as one cycle. | | OG001 | Phase Ib: Fisogatinib (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg | Phase Ib: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle. |
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| Secondary | Phase Ib: Objective Response Rate (ORR) Assessed by Investigator Based on RECIST Version 1.1 | Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1 .1) for target lesions and assessed by MRI/ CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), > =30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR. Percentage of subjects who achieve objective tumor response (CR or PR) will be summarized. | | Posted | | Count of Participants | | Participants | | Imaging (CT or MRI) assessments per RECIST v1.1 will be performed within 28 days prior to the first dose (baseline assessment), every 9 weeks during the first year of the study, and every 12 weeks thereafter. Up to 22 months. | | | | ID | Title | Description |
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| OG000 | Phase Ib: Fisogatinb (BLU-554) 400mg in Combination With Sugemalimab (CS1001) 1200mg | Phase Ib: participants received 400 mg Fisogatinib (BLU-554) once daily (QD), in combination with 1200mg fixed dose Sugemalimab (CS1001) once every 3 weeks (Q3W). Every 21 days (3 weeks) will be considered as one cycle. | | OG001 | Phase Ib: Fisogatinb (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg | Phase Ib: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle. |
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| Secondary | Patients With Anti-CS1001 Antibody | | | Posted | | Count of Participants | | Participants | | Pre-dose of Cycle 1, 2, 4, 5, 7, 10, 13, 16 and every 8 cycles thereafter. Up to 22 months. | | | | ID | Title | Description |
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| OG000 | Phase Ib: Fisogatinib (BLU-554) 400mg in Combination With Sugemalimab (CS1001) 1200mg | Phase Ib: participants received 400 mg Fisogatinib (BLU-554) once daily (QD), in combination with 1200mg fixed dose Sugemalimab (CS1001) once every 3 weeks (Q3W). Every 21 days (3 weeks) will be considered as one cycle. | | OG001 | Phase Ib: Fisogatinib (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg | Phase Ib: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle. | | OG002 | Phase II: Fisogatinib (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg | Phase II: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle. |
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| Secondary | Overall Survival | Overall survival is defined as the time interval between the date of the first investigational product dose to the date of death from any cause | | Posted | | Median | 95% Confidence Interval | Months | | Subject should be followed from time of registration till the time of subject death. Up to 22 months. | | | | ID | Title | Description |
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| OG000 | Phase Ib: Fisogatinib (BLU-554) 400mg in Combination With Sugemalimab (CS1001) 1200mg | Phase Ib: participants received 400 mg Fisogatinib (BLU-554) once daily (QD), in combination with 1200mg fixed dose Sugemalimab (CS1001) once every 3 weeks (Q3W). Every 21 days (3 weeks) will be considered as one cycle. | | OG001 | Phase Ib: Fisogatinib (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg | Phase Ib: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle. | | OG002 | Phase II: Fisogatinib (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg | Phase II: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle. |
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| Secondary | Disease Control Rate by PD-L1 Protein Level | | Efficacy analysis dataset with dichotomous PD-L1 parameters at baseline. | Posted | | Count of Participants | | Participants | | Imaging (CT or MRI) assessments by FGF19 protein and PD-L1 protein level will be performed within 28 days prior to the first dose (baseline assessment), every 9 weeks during the first year of the study, and every 12 weeks thereafter. Up to 22 months. | | | | ID | Title | Description |
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| OG000 | Phase II: BLU-554 600mg in Combination With CS1001 1200mg With IC Percentage <1 Percentage | Phase II: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle. | | OG001 | Phase II: BLU-554 600mg in Combination With CS1001 1200mg With IC Percentage >=1 Percentage | Phase II: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle. | | OG002 | Phase II: BLU-554 600mg in Combination With CS1001 1200mg With TC Percentage <1 Percentage | Phase II: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle. |
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| Secondary | Objective Response Rate (ORR) by PD-L1 Protein Level | | Efficacy analysis dataset with dichotomous PD-L1 parameters at baseline. | Posted | | Count of Participants | | Participants | | Imaging (CT or MRI) assessments by FGF19 protein and PD-L1 protein level will be performed within 28 days prior to the first dose (baseline assessment), every 9 weeks during the first year of the study, and every 12 weeks thereafter. Up to 22 months. | | | | ID | Title | Description |
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| OG000 | Phase II: BLU-554 600mg in Combination With CS1001 1200mg With IC Percentage <1 Percentage | Phase II: patients received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle. | | OG001 | Phase II: BLU-554 600mg in Combination With CS1001 1200mg With IC Percentage >=1 Percentage | Phase II: patients received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle. | | OG002 | Phase II: BLU-554 600mg in Combination With CS1001 1200mg With TC Percentage <1 Percentage | Phase II: patients received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle. |
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| Secondary | Progression-free Survival Assessed by Investigator | Progression-free Survival is defined as the time from the date of first study dose to disease progression or death (whichever occurs first). | | Posted | | Median | 95% Confidence Interval | Months | | Imaging (CT or MRI) assessments per RECIST v1.1 will be performed within 28 days prior to the first dose (baseline assessment), every 9 weeks during the first year of the study, and every 12 weeks thereafter. Up to 22 months. | | | | ID | Title | Description |
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| OG000 | Phase Ib: Fisogatinb (BLU-554) 400mg in Combination With Sugemalimab (CS1001) 1200mg | Phase Ib: participants received 400 mg Fisogatinib (BLU-554) once daily (QD), in combination with 1200mg fixed dose Sugemalimab (CS1001) once every 3 weeks (Q3W). Every 21 days (3 weeks) will be considered as one cycle. | | OG001 | Phase Ib: Fisogatinb (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg | Phase Ib: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle. | | OG002 | Phase II: Fisogatinb (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg | Phase II: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle. |
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| Secondary | Time to Progression Assessed by Investigator | Time to Progression is defined as the time from the date of first study dose to disease progression. Subjects without event (no disease progression) will be censored at the date of "last tumor assessment". | | Posted | | Median | 95% Confidence Interval | Months | | Imaging (CT or MRI) assessments per RECIST v1.1 will be performed within 28 days prior to the first dose (baseline assessment), every 9 weeks during the first year of the study, and every 12 weeks thereafter. Up to 22 months. | | | | ID | Title | Description |
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| OG000 | Phase Ib: Fisogatinb (BLU-554) 400mg in Combination With Sugemalimab (CS1001) 1200mg | Phase Ib: participants received 400 mg Fisogatinib (BLU-554) once daily (QD), in combination with 1200mg fixed dose Sugemalimab (CS1001) once every 3 weeks (Q3W). Every 21 days (3 weeks) will be considered as one cycle. | | OG001 | Phase Ib: Fisogatinb (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg | Phase Ib: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle. | | OG002 | Phase II: Fisogatinb (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg | Phase II: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle. |
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| Secondary | Phase II: Safety and Tolerance | An AE was any untoward medical occurrence after clinical study subjects receive study drug. An SAE was any event that meets any the following criteria: death, life-threatening; inpatient hospitalization or prolongation, persistent or significant disability/incapacity;congenital malformation/birth defects and significant medical events. AE and SAE were graded by CTCAE version 5.0 by severity, from Grade 1 mild to Grade 5 death related AE. | Baseline Analysis Population consists of all participants receiving at least one dose of investigational product | Posted | | Count of Participants | | Participants | | Safety and tolerance assessments continued for the duration of treatment. AEs and SAEs will be collected from time of signature of main informed consent, throughout the treatment period and including the follow-up period, up to approximate 22 months. | | | | ID | Title | Description |
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| OG000 | Phase II: Fisogatinib (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg | Phase II: participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle. |
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| Secondary | Pharmacokinetic Parameters of Accumulation Ratio of Fisogatinib (BLU-554) | Pharmacokinetic(PK) parameters of accumulation ratio of Fisogatinib (BLU-554),Rac,AUC. Only participants with evaluable PK results were included in the analysis. Where data is not presented, the PK profiles were non-measurable. Results for Phase Ib and Phase II have been pooled for the same dosage. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | ratio | | For BLU554, Cycle 1 day 1( 0, 0.5 to 24 hour post dose) and Cycle 2 day 1( 0, 0.5 to 24 hour post dose). | | | | ID | Title | Description |
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| OG000 | Phase Ib: Fisogatinib (BLU-554) 400mg in Combination With Sugemalimab (CS1001) 1200mg | Participants received 400 mg Fisogatinib (BLU-554) once daily (QD), in combination with 1200mg fixed dose Sugemalimab (CS1001) once every 3 weeks (Q3W). Every 21 days (3 weeks) will be considered as one cycle. | | OG001 | Phase Ib and Phase II: Fisogatinib (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg | Participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle. |
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| Secondary | Pharmacokinetic Parameters of Area Under the Serum Concentration-time Curve (AUC) of Fisogatinib (BLU-554) | Pharmacokinetic parameters of area under the serum concentration-time curve (AUC0-τ,ss, Time from 0 to 24h) of Fisogatinib (BLU-554). Only participants with evaluable PK results were included in the analysis. Where data is not presented, the PK profiles were non-measurable. Results for Phase Ib and Phase II have been pooled for the same dosage. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*μg/mL | | For BLU554, Cycle 1 day 1( 0, 0.5 to 24 hour post dose) and Cycle 2 day 1( 0, 0.5 to 24 hour post dose). | | | | ID | Title | Description |
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| OG000 | Phase Ib: Fisogatinib (BLU-554) 400mg in Combination With Sugemalimab (CS1001) 1200mg | Participants received 400 mg Fisogatinib (BLU-554) once daily (QD), in combination with 1200mg fixed dose Sugemalimab (CS1001) once every 3 weeks (Q3W). Every 21 days (3 weeks) will be considered as one cycle. | | OG001 | Phase Ib and Phase II: Fisogatinib (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg | Participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle. |
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| Secondary | Pharmacokinetic Parameters of Clearance at Steady State (CLss) of Fisogatinib (BLU-554) | Pharmacokinetic Parameters of Clearance at Steady State (Clss) of Fisogatinib (BLU-554). Only participants with evaluable PK results were included in the analysis. Where data is not presented, the PK profiles were non-measurable. Results for Phase Ib and Phase II have been pooled for the same dosage. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | L/h | | For BLU554, Cycle 1 day 1( 0, 0.5 to 24 hour post dose) and Cycle 2 day 1( 0, 0.5 to 24 hour post dose). | | | | ID | Title | Description |
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| OG000 | Phase Ib: Fisogatinib (BLU-554) 400mg in Combination With Sugemalimab (CS1001) 1200mg | Participants received 400 mg Fisogatinib (BLU-554) once daily (QD), in combination with 1200mg fixed dose Sugemalimab (CS1001) once every 3 weeks (Q3W). Every 21 days (3 weeks) will be considered as one cycle. | | OG001 | Phase Ib and Phase II: Fisogatinib (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg | Participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle. |
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| Secondary | Pharmacokinetic Parameters of Maximum Serum Concentration (Cmax) of Fisogatinib (BLU-554) | PK Parameters of Cmax of Fisogatinib (BLU-554). Only participants with evaluable PK results were included in the analysis. Where data is not presented, the PK profiles were non-measurable. Results for Phase Ib and Phase II have been pooled for the same dosage. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | μg/mL | | For BLU554, Cycle 1 day 1( 0, 0.5 to 24 hour post dose) and Cycle 2 day 1( 0, 0.5 to 24 hour post dose). | | | | ID | Title | Description |
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| OG000 | Phase Ib: Fisogatinib (BLU-554) 400mg in Combination With Sugemalimab (CS1001) 1200mg | Participants received 400 mg Fisogatinib (BLU-554) once daily (QD), in combination with 1200mg fixed dose Sugemalimab (CS1001) once every 3 weeks (Q3W). Every 21 days (3 weeks) will be considered as one cycle. | | OG001 | Phase Ib and Phase II: Fisogatinib (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg | Participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle. |
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| Secondary | Pharmacokinetic Parameters of Time to Maximum Serum Concentration (Tmax) of Fisogatinib (BLU-554) | PK Parameters of Tmax of Fisogatinib (BLU-554). Only participants with evaluable PK results were included in the analysis. Where data is not presented, the PK profiles were non-measurable. Results for Phase Ib and Phase II have been pooled for the same dosage. | | Posted | | Median | Full Range | hour | | For BLU554, Cycle 1 day 1( 0, 0.5 to 24 hour post dose) and Cycle 2 day 1( 0, 0.5 to 24 hour post dose). | | | | ID | Title | Description |
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| OG000 | Phase Ib: Fisogatinib (BLU-554) 400mg in Combination With Sugemalimab (CS1001) 1200mg | Participants received 400 mg Fisogatinib (BLU-554) once daily (QD), in combination with 1200mg fixed dose Sugemalimab (CS1001) once every 3 weeks (Q3W). Every 21 days (3 weeks) will be considered as one cycle. | | OG001 | Phase Ib and Phase II: Fisogatinib (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg | Participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle. |
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| Secondary | Pharmacokinetic Parameters of Accumulation Ratio of Sugemalimab (CS1001) | PK Parameters of Rac, AUC of Sugemalimab (CS1001). Only participants with evaluable PK results were included in the analysis. Where data is not presented, the PK profiles were non-measurable. Results for Phase Ib and Phase II have been pooled for the same dosage. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | ratio | | For CS1001: Cycle 1 day 1(0, 0.5 to 504 hour post dose) and Cycle 4 day 1 (0, 0.5 to 504 hour post dose). | | | | ID | Title | Description |
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| OG000 | Phase Ib: Fisogatinib (BLU-554) 400mg in Combination With Sugemalimab (CS1001) 1200mg | Participants received 400 mg Fisogatinib (BLU-554) once daily (QD), in combination with 1200mg fixed dose Sugemalimab (CS1001) once every 3 weeks (Q3W). Every 21 days (3 weeks) will be considered as one cycle. | | OG001 | Phase Ib and Phase II: Fisogatinib (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg | Participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle. |
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| Secondary | Pharmacokinetic Parameters of Area Under the Serum Concentration-time Curve (AUC ) of Sugemalimab (CS1001) | PK Parameters of (AUC 0-τ,ss ) of Sugemalimab (CS1001). Only participants with evaluable PK results were included in the analysis. Where data is not presented, the PK profiles were non-measurable. Results for Phase Ib and Phase II have been pooled for the same dosage. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*μg/mL | | For CS1001: Cycle 1 day 1(0, 0.5 to 504 hour post dose) and Cycle 4 day 1 (0, 0.5 to 504 hour post dose). | | | | ID | Title | Description |
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| OG000 | Phase Ib: Fisogatinib (BLU-554) 400mg in Combination With Sugemalimab (CS1001) 1200mg | Participants received 400 mg Fisogatinib (BLU-554) once daily (QD), in combination with 1200mg fixed dose Sugemalimab (CS1001) once every 3 weeks (Q3W). Every 21 days (3 weeks) will be considered as one cycle. | | OG001 | Phase Ib and Phase II: Fisogatinib (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg | Participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle. |
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| Secondary | Pharmacokinetic Parameters of Clearance at Steady State (CLss) of Sugemalimab (CS1001) | PK Parameters of CLss of Sugemalimab (CS1001). Only participants with evaluable PK results were included in the analysis. Where data is not presented, the PK profiles were non-measurable. Results for Phase Ib and Phase II have been pooled for the same dosage. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | L/h | | For CS1001: Cycle 1 day 1(0, 0.5 to 504 hour post dose) and Cycle 4 day 1 (0, 0.5 to 504 hour post dose). | | | | ID | Title | Description |
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| OG000 | Phase Ib: Fisogatinib (BLU-554) 400mg in Combination With Sugemalimab (CS1001) 1200mg | Participants received 400 mg Fisogatinib (BLU-554) once daily (QD), in combination with 1200mg fixed dose Sugemalimab (CS1001) once every 3 weeks (Q3W). Every 21 days (3 weeks) will be considered as one cycle. | | OG001 | Phase Ib and Phase II: Fisogatinib (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg | Participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle. |
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| Secondary | Pharmacokinetic Parameters of Maximum Serum Concentration (Cmax) of Sugemalimab (CS1001) | PK Parameters of Cmax of Sugemalimab (CS1001). Only participants with evaluable PK results were included in the analysis. Where data is not presented, the PK profiles were non-measurable. Results for Phase Ib and Phase II have been pooled for the same dosage. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | μg/mL | | For CS1001: Cycle 1 day 1(0, 0.5 to 504 hour post dose) and Cycle 4 day 1 (0, 0.5 to 504 hour post dose). | | | | ID | Title | Description |
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| OG000 | Phase Ib: Fisogatinib (BLU-554) 400mg in Combination With Sugemalimab (CS1001) 1200mg | Participants received 400 mg Fisogatinib (BLU-554) once daily (QD), in combination with 1200mg fixed dose Sugemalimab (CS1001) once every 3 weeks (Q3W). Every 21 days (3 weeks) will be considered as one cycle. | | OG001 | Phase Ib and Phase II: Fisogatinib (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg | Participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle. |
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| Secondary | Pharmacokinetic Parameters of Time to Maximum Serum Concentration (Tmax) of Sugemalimab (CS1001) | PK Parameters of Tmax of Sugemalimab (CS1001). Only participants with evaluable PK results were included in the analysis. Where data is not presented, the PK profiles were non-measurable. Results for Phase Ib and Phase II have been pooled for the same dosage. | | Posted | | Median | Full Range | hour | | For CS1001: Cycle 1 day 1(0, 0.5 to 504 hour post dose) and Cycle 4 day 1 (0, 0.5 to 504 hour post dose). | | | | ID | Title | Description |
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| OG000 | Phase Ib: Fisogatinib (BLU-554) 400mg in Combination With Sugemalimab (CS1001) 1200mg | Participants received 400 mg Fisogatinib (BLU-554) once daily (QD), in combination with 1200mg fixed dose Sugemalimab (CS1001) once every 3 weeks (Q3W). Every 21 days (3 weeks) will be considered as one cycle. | | OG001 | Phase Ib and Phase II: Fisogatinib (BLU-554) 600mg in Combination With Sugemalimab (CS1001) 1200mg | Participants received 600 mg Fisogatinib (BLU-554) QD, in combination with 1200mg fixed dose Sugemalimab (CS1001) Q3W. Every 21 days (3 weeks) will be considered as one cycle. |
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