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Phase Ib: Fisogatinib in combination with Sugemalimab

Phase 1

Hepatocellular Carcinoma | Small molecule | Oncology |Blueprint Medicines Corporation|Last Updated: Feb 6, 2023

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment26

FDA Designations

No designations recorded

Clinical trial landscape

Phase Ib: Fisogatinib in combination with Sugemalimab · 1 trial · 1 indication

Phase 1 1
NCT04194801A Phase Ib/II Study of Fisogatinib(BLU-554) in Subjects With Hepatocellular CarcinomaHepatocellular Carcinoma
COMPLETED26 Analytics
PHASE1COMPLETED
A Phase Ib/II Study of Fisogatinib(BLU-554) in Subjects With Hepatocellular Carcinoma
Hepatocellular Carcinoma
NCT0419480126
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Study Endpoints

Primary Endpoints

Phase Ib: Patients With Event(s) of Dose-limiting Toxicity
Cycle 1 (21 days) of treatment

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.

Phase Ib: Safety and Tolerance
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.

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.

Phase II: Objective Response Rate (ORR) Assessed by Investigator Based on RECIST Version 1.1
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.

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.

Secondary Endpoints

Disease Control Rate Assessed by Investigator
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.
Duration of Response Assessed by Investigator
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.
Phase Ib: Objective Response Rate (ORR) Assessed by Investigator Based on RECIST Version 1.1
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.
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Phase Ib: Fisogatinib (BLU-554) 400mg in combination with Sugemalimab (CS1001) 1200mgEXPERIMENTAL -
Phase Ib: Fisogatinib (BLU-554) 600mg in combination with Sugemalimab (CS1001) 1200mgEXPERIMENTAL -
Phase II: Fisogatinib (BLU-554) 600mg in combination with Sugemalimab (CS1001) 1200mgEXPERIMENTAL -

Interventions

NameTypeDescription
Phase Ib: Fisogatinib (BLU-554) 400mg in combination with Sugemalimab (CS1001) 1200mgDRUGPhase 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.
Phase Ib: Fisogatinib (BLU-554) 600mg in combination with Sugemalimab (CS1001) 1200mgDRUGPhase 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.
Phase II: Fisogatinib (BLU-554) 600mg in combination with Sugemalimab (CS1001) 1200mgDRUGPhase 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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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion criteria: 1. Voluntarily participate in the clinical study. Fully understand and get informed of this study and sign the Informed Consent Form (ICF). 2. ≥18 years of age on day of signing the informed consent. 3. Unresectable locally advanced or metastatic hepatocellular carcinoma as conf...

Countries:China
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