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

NCT05537987 | Unknown Phase 1 FDA Drug

• 1 other identifier: ICP-CL-00502
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

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

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

Study Arms (1)

ICP-723

EXPERIMENTAL

Drug: ICP-723

Interventions

ICP-723 DRUG

3+3 dose escalation

ICP-723

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 1.1.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• InnoCare Pharma Inc.: lead

Study Sites (3)

University of Kansas Medical / Cancer Centers

Kansas City, Kansas, 66506, United States

Location

NYU-Langone Medical Center

New York, New York, 10016, United States

Location

Northwest Medical Specialties

Tacoma, Washington, 98405, United States

Location

Study Officials

• Jun Zhang

  University of Kansas Medical / Cancer Centers

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2022
• First Posted: September 13, 2022
• Study Start: July 30, 2021
• Primary Completion: November 1, 2023
• Study Completion: July 1, 2024
• Last Updated: January 20, 2023

Record last verified: 2023-01

Locations

US (3)