Clinical trial NCT05537987: Evaluate the Safety, Tolerability, and Pharmacokinetics of ICP-723 in Patients With Advanced Solid Tumors
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Advanced Solid Tumors
Lead sponsor: InnoCare Pharma Inc.
Sponsor class: INDUSTRY
First posted: 2022-09-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Incidence and severity of dose-limiting toxicity (DLT), adverse events (AEs), and serious adverse events (SAEs). Frequency of dose interruptions, reductions and intensity
timeFrame: through study completion, an average of 1.5 years.
Secondary outcomes:
measure: Objective response rate (ORR) determined using RECIST 1.1 criteria.
timeFrame: Through study completion, an average of 4 years
measure: Disease control rate (DCR) determined using RECIST 1.1 criteria.
timeFrame: Through study completion, an average of 4 years
measure: Peak concentration (Cmax)
timeFrame: Through study completion, an average of 4 years
measure: Time to reach peak concentration (Tmax)
timeFrame: Through study completion, an average of 4 years
measure: Half-life (t1/2)
timeFrame: Through study completion, an average of 4 years
measure: Area under the plasma concentration-time curve (AUC0-∞ and AUC0-t)
timeFrame: Through study completion, an average of 4 years
measure: Apparent clearance (CL/F)
timeFrame: Through study completion, an average of 4 years
measure: Apparent volume of distribution (Vz/F),
timeFrame: Through study completion, an average of 4 years
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical / Cancer Centers
state: Kansas
city: New York
country: United States
facility: NYU-Langone Medical Center
state: New York
city: Tacoma
country: United States
facility: Northwest Medical Specialties
state: Washington
Study officials:
affiliation: University of Kansas Medical / Cancer Centers
name: Jun Zhang
role: PRINCIPAL_INVESTIGATOR
References: