Study of ICP-105 in Solid Tumors Patients

Solid Tumor Clinical Trial

Official title:

A Phase I, Open-Label Study to Assess the Safety, Tolerability, Pharmacokinetics of ICP-105 in Patients With Advanced Solid Malignancies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03642834
• Other study ID #: ICP-CL-00201
• Status: Completed
• Phase: Phase 1
• Start date: September 21, 2018
• Est. completion date: March 1, 2021

Study information

• Verified date: June 2022
• Source: Beijing InnoCare Pharma Tech Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Open-label, non-randomized, Phase I, dose-escalating, first-in-man study.

Description:

The study consisted of a screening period, a treatment period with repeated 28-day treatment cycles (duration treatment with ICP-105), and a follow-up period (within 30 days of the last dose and post-treatment follow-up 30 days after the last visit). The recruited patients receive a single dose on day 1, then after a 3-day washout period, multiple dosing will be initiated following dose-escalation schedule. The dose-limiting toxicity (DLT) assessment period consisted of Cycle 0 (single dose and washout period) and Cycle 1 (28-day cycle).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: March 1, 2021
• Est. primary completion date: December 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 Years and older.

• Eastern Cooperative Oncology Group (ECOG) performance status = 1.

• At least one evaluable disease according to RECIST1.1.

• Histologically or cytologically confirmed solid tumors, failure to respond to standard therapy, or for whom standard therapy does not exist.

• Adequate bone marrow, liver, renal, and cardiovascular function.

Exclusion Criteria:

• Previous treatment with FGF19, FGFR4 inhibitors and/or pan-FGFR inhibitors.

• Anti-cancer therapy, such as chemotherapy, immunotherapy, hormonal, targeted therapy, or investigational agents within four weeks of the first dose of ICP-105.

• Major surgery within 6 weeks of the first dose of ICP-105.

• Significant GI disorder(s) that could interfere with the absorption, metabolism, or excretion of ICP-105.

• Crohn's disease with symptoms and systemic treatment.

• Central nervous system (CNS) metastasis.

• Current clinically significant cardiovascular disease including:

• Any class 3 or 4 cardiac disease such as arrhythmia, congestive heart failure or myocardial infarction defined by the New York Heart Association Functional Classification, or left ventricular ejection fraction (LVEF) < 50%, Primary cardiomyopathy, clinical significant QTc prolong history or QTc>470ms (female) QTc>450ms (male).

• Known active bleeding within 2 months of screening or 6 months of bleeding history.

• Lung function impairment by pleural effusion or ascites, any history of interstitial pneumonia, deep vein thrombosis, pulmonary embolism.

• Known active infection with HBV, HCV or HIV or any uncontrolled active systemic infection.

• Non-hematological toxicity must recover to = Grade 1 from prior anti-cancer therapy (excluding alopecia, nausea and vomiting).

• Lactating or pregnant women, or women who will not use contraception during the study and for 180 days after the last dose of study drug if sexually active and able to bear children.

Related Conditions & MeSH terms

• Solid Tumor

Intervention

Drug:
• ICP-105
25mg, 100mg capsule

Locations

Country	Name	City	State
China	Shanghai East Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Beijing InnoCare Pharma Tech Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	will be evaluated by CTCAE v4.03	Every cycle (28 days) for approximately 24 months or earlier if patient terminates from the study
Secondary	Cmax	the peak plasma concentration	Every cycle (28 days) for approximately 24 months or earlier if patient terminates from the study
Secondary	AUC	area under the plasma concentration vs. time curve	Every cycle (28 days) for approximately 24 months or earlier if patient terminates from the study
Secondary	Apparent half-life for designated elimination phases (t½)	will be measured and calculated with noncompartmental analysis using WinNonlin	Every cycle (28 days) for approximately 24 months or earlier if patient terminates from the study