Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 Design

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
ICP-723
  • Drug: ICP-723
    3+3 dose escalation

Recruiting Locations

University of Kansas Medical / Cancer Centers
Kansas City, Kansas 66506
Contact:
Jun Zhang

More Details

Status
Recruiting
Sponsor
InnoCare Pharma Inc.

Study Contact

Olivia Yang
+1 (609) 524-0684
ClinicalTrialsInfo@innocarepharma.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.