Study of ICP-105 in Solid Tumors Patients

NCT ID: NCT03642834

Last Updated: 2022-07-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-21
• Study Completion Date: 2021-03-01

Brief Summary

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

Detailed 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).

Conditions

Solid Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ICP-105 Single Arm

ICP-105 of multiple dose levels, dose escalation steps may be modified based on the safety from the previous dose.

Group Type: EXPERIMENTAL

ICP-105

Intervention Type: DRUG

25mg, 100mg capsule

Interventions

ICP-105

25mg, 100mg capsule

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing InnoCare Pharma Tech Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jin Li, PhD

Role: PRINCIPAL_INVESTIGATOR

Shanghai East Hospital

Locations

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

ICP-CL-00201

Identifier Type: -

Identifier Source: org_study_id