A Multicenter, Open-Label Phase I Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of ICP-723 in Patients With Advanced Solid Tumors

InnoCare Pharma Inc.3 sites in 1 country30 target enrollmentJuly 30, 2021

ConditionsAdvanced Solid Tumors

InterventionsICP-723

DrugsICP-723

Overview

Phase: Phase 1
Intervention: ICP-723
Conditions: Advanced Solid Tumors
Sponsor: InnoCare Pharma Inc.
Enrollment: 30
Locations: 3
Primary Endpoint: Incidence and severity of dose-limiting toxicity (DLT), adverse events (AEs), and serious adverse events (SAEs). Frequency of dose interruptions, reductions and intensity
Status: Active, not recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

During this study, dose escalation will be conducted in subjects with advanced solid tumors who have experienced treatment failure after clinical standard of care treatments or who currently have no effective treatment available to evaluate the safety, tolerability, and PK of ICP-723

Registry

clinicaltrials.gov

Start Date

July 30, 2021

End Date

July 2024

Last Updated

3 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

InnoCare Pharma Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients with histopathologically confirmed locally advanced malignant solid tumors that are unresectable or metastatic and that are unresponsive to standard treatments or have relapsed; patients who have progressed under standard treatment including prior treatment with TRK or ROS1 inhibitors.
•Male or female patients with age ≥18 years old and ≤80 years old.
•Measurable lesion according to RECIST 1.
•Adequate organ functions that meet protocol requirement criteria.
•Patients with asymptomatic, stable primary central nervous system (CNS) tumors or CNS metastases (treated or untreated)
•Participates voluntarily, signs informed consent, and follows the study treatment plan and scheduled visits.

Exclusion Criteria

•Other than the advanced malignant solid tumor under study, patients with another one or more active malignancies within the previous 5 years except for locally curable cancers that have been apparently cured
•Received systemic anti-cancer therapy including chemotherapy (except for oral fluorouracil chemotherapy), radiation therapy, hormones, targeted drugs, or biological immunotherapy within 4 weeks or 5 half-lives
•Major surgery (thoracotomy, laparotomy, etc.) within 4 weeks or minor surgery (superficial skin surgery, lymphadenectomy, hernia repair, etc.) within 2 weeks before the first dose of the study drug
•Clinically significant gastrointestinal/neurological dysfunction that may affect drug intake, transport, or absorption.
•Has evidence of uncontrolled heart disease
•At the investigator's discretion, evidence of severe or uncontrolled systemic disease.
•Other conditions considered by the investigator to be inappropriate for participation in this study.

Arms & Interventions

ICP-723

Intervention: ICP-723

Outcomes

Primary Outcomes

Incidence and severity of dose-limiting toxicity (DLT), adverse events (AEs), and serious adverse events (SAEs). Frequency of dose interruptions, reductions and intensity

Time Frame: through study completion, an average of 1.5 years.

Secondary Outcomes

Objective response rate (ORR) determined using RECIST 1.1 criteria.(Through study completion, an average of 4 years)
Half-life (t1/2)(Through study completion, an average of 4 years)
Apparent volume of distribution (Vz/F),(Through study completion, an average of 4 years)
Disease control rate (DCR) determined using RECIST 1.1 criteria.(Through study completion, an average of 4 years)
Apparent clearance (CL/F)(Through study completion, an average of 4 years)
Peak concentration (Cmax)(Through study completion, an average of 4 years)
Time to reach peak concentration (Tmax)(Through study completion, an average of 4 years)
Area under the plasma concentration-time curve (AUC0-∞ and AUC0-t)(Through study completion, an average of 4 years)