A Study of ICP-192 in Patients With FGFR2-Rearranged Unresectable or Metastatic Intrahepatic Cholangiocarcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing InnoCare Pharma Tech Co., Ltd.
About this trial
This is a single-arm, open-label, multi-center phase 2 clinical trial of ICP-192. The purpose of this study is to evaluate the efficacy and safety in patients with FGFR2-Rearranged unresectable or metastatic intrahepatic cholangiocarcinoma who failed prior therapy
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Signed the ICF and Age ≥ 18 years old, either sex.
ECOG score of 0-1.
Life expectancy > 3 months.
Histopathologically or cytopathologically confirmed intrahepatic cholangiocarcinoma with unresectable, recurrent or metastatic (AJCC 2017, 8th edition, TNM stage IV) tumor that has progressed following at least one line of chemotherapy and progression/recurrence within 6 months after neoadjuvant/adjuvant chemotherapy may be included.
Disqualifiers
Presence of other malignancies requiring medical intervention.
Prior treatment with selective FGFR inhibitors or FGFR antibodies.
Treatment with biological products, radical radiotherapy, and other investigational drugs within 4 weeks prior to the first dose of study drug. Chemotherapy within 3 weeks prior to the first dose of study drug.
Known symptomatic central nervous system (CNS) metastases.
Trial design
Design model
Single group
Treatments tested in this trial
ICP-192
DrugICP-192 is a round, uncoated tablet, 5mg, orally.
Treatment groups
70 Participants
are divided into 1 treatment groupGroup A: ICP-192Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Objective response rate (ORR)
Time frame
Up to 3 yearsSecondary outcomes
1
Progression-free survival (PFS)
Time frame
Up to 3 years2
Disease control rate (DCR)
Time frame
Up to 3 years3
Duration of response (DOR)
Time frame
Up to 3 years4
Time to response (TTR)
Time frame
Up to 3 yearsOther outcomes
1
To explore the relationship between blood phosphorus and clinical efficacy
Time frame
Up to 3 yearsSponsors and contacts
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Source ClinicalTrials.gov