Evaluate the Safety, Tolerability, and Pharmacokinetics of ICP-723 in Patients With Advanced Solid Tumors

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Drug: ICP-723

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66506
      • University of Kansas Medical / Cancer Centers
  • New York
    • New York, New York, United States, 10016
      • NYU-Langone Medical Center
  • Washington
    • Tacoma, Washington, United States, 98405
      • Northwest Medical Specialties

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:

1. 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.
2. Male or female patients with age ≥18 years old and ≤80 years old.
3. Measurable lesion according to RECIST 1.1.
4. Adequate organ functions that meet protocol requirement criteria.
5. Patients with asymptomatic, stable primary central nervous system (CNS) tumors or CNS metastases (treated or untreated)
6. Participates voluntarily, signs informed consent, and follows the study treatment plan and scheduled visits.

Exclusion Criteria:

1. 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
2. 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
3. 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
4. Clinically significant gastrointestinal/neurological dysfunction that may affect drug intake, transport, or absorption.
5. Has evidence of uncontrolled heart disease
6. At the investigator's discretion, evidence of severe or uncontrolled systemic disease.
7. Other conditions considered by the investigator to be inappropriate for participation in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ICP-723	Drug: ICP-723; 3+3 dose escalation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence and severity of dose-limiting toxicity (DLT), adverse events (AEs), and serious adverse events (SAEs). Frequency of dose interruptions, reductions and intensity	through study completion, an average of 1.5 years.

Secondary Outcome Measures

Outcome Measure	Time Frame
Objective response rate (ORR) determined using RECIST 1.1 criteria.	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
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
Half-life (t1/2)	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
Apparent clearance (CL/F)	Through study completion, an average of 4 years
Apparent volume of distribution (Vz/F),	Through study completion, an average of 4 years

Collaborators and Investigators

• Sponsor: InnoCare Pharma Inc.
• Investigators: Principal Investigator: Jun Zhang, University of Kansas Medical / Cancer Centers

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2021
• Primary Completion (Anticipated): November 1, 2023
• Study Completion (Anticipated): July 1, 2024

Study Registration Dates

• First Submitted: September 8, 2022
• First Submitted That Met QC Criteria: September 8, 2022
• First Posted (Actual): September 13, 2022

Study Record Updates

• Last Update Posted (Actual): January 20, 2023
• Last Update Submitted That Met QC Criteria: January 18, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: ICP-CL-00502

Drug and device information, study documents

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