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Trial Title:
Evaluate the Safety, Tolerability, and Pharmacokinetics of ICP-723 in Patients With Advanced Solid Tumors
NCT ID:
NCT05537987
Condition:
Advanced Solid Tumors
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
ICP-723
Description:
3+3 dose escalation
Arm group label:
ICP-723
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
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Kansas Medical / Cancer Centers
Address:
City:
Kansas City
Zip:
66506
Country:
United States
Facility:
Name:
NYU-Langone Medical Center
Address:
City:
New York
Zip:
10016
Country:
United States
Facility:
Name:
Northwest Medical Specialties
Address:
City:
Tacoma
Zip:
98405
Country:
United States
Start date:
July 30, 2021
Completion date:
July 2024
Lead sponsor:
Agency:
InnoCare Pharma Inc.
Agency class:
Industry
Source:
InnoCare Pharma Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05537987
