Study of ICP-105 in Solid Tumors Patients

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

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

Study Overview

• Status: Completed
• Conditions: Solid Tumor
• Intervention / Treatment: Drug: ICP-105

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).

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200120
      • Shanghai East Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SEQUENTIAL
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: ICP-105 Single Arm; ICP-105 of multiple dose levels, dose escalation steps may be modified based on the safety from the previous dose.	Drug: ICP-105; 25mg, 100mg capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	the peak plasma concentration	Every cycle (28 days) for approximately 24 months or earlier if patient terminates from the study
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
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

Collaborators and Investigators

• Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 21, 2018
• Primary Completion (ACTUAL): December 14, 2020
• Study Completion (ACTUAL): March 1, 2021

Study Registration Dates

• First Submitted: August 17, 2018
• First Submitted That Met QC Criteria: August 20, 2018
• First Posted (ACTUAL): August 22, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 6, 2022
• Last Update Submitted That Met QC Criteria: July 5, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: ICP-CL-00201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No