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

Advanced Solid Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05537987
• Other study ID #: ICP-CL-00502
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: July 30, 2021
• Est. completion date: July 2024

Study information

• Verified date: January 2023
• Source: InnoCare Pharma Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: July 2024
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Neoplasms

Intervention

Drug:
• ICP-723
3+3 dose escalation

Locations

Country	Name	City	State
United States	University of Kansas Medical / Cancer Centers	Kansas City	Kansas
United States	NYU-Langone Medical Center	New York	New York
United States	Northwest Medical Specialties	Tacoma	Washington

Sponsors (1)

Lead Sponsor	Collaborator
InnoCare Pharma Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Objective response rate (ORR) determined using RECIST 1.1 criteria.		Through study completion, an average of 4 years
Secondary	Disease control rate (DCR) determined using RECIST 1.1 criteria.		Through study completion, an average of 4 years
Secondary	Peak concentration (Cmax)		Through study completion, an average of 4 years
Secondary	Time to reach peak concentration (Tmax)		Through study completion, an average of 4 years
Secondary	Half-life (t1/2)		Through study completion, an average of 4 years
Secondary	Area under the plasma concentration-time curve (AUC0-8 and AUC0-t)		Through study completion, an average of 4 years
Secondary	Apparent clearance (CL/F)		Through study completion, an average of 4 years
Secondary	Apparent volume of distribution (Vz/F),		Through study completion, an average of 4 years