Clinical trial NCT05367232: A Study of ICP-033 in Patients With Advanced Solid Tumors
Official title: A Phase I Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of ICP-033 in Patients With Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Patients With Advanced Solid Tumors
Lead sponsor: Beijing InnoCare Pharma Tech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-05-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A Dose finding Study to Evaluate the Safety, Tolerability and Pharmacokinetics and Preliminary Anti-Tumor Activity of ICP-033 Tablets in Patients with Advanced Solid Tumors.


Eligibility criteria: Inclusion Criteria:

1. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
2. Patients with histologically confirmed locally advanced unresectable or metastatic solid tumors;
3. At least one measurable lesion according to RECIST 1.1.

Exclusion Criteria:

1. Pregnant and lactating women, or women planning to become pregnant during the study through at least 6 months after the last dose of study drug.
2. Patients with unstable primary central nervous system (CNS) tumors or CNS metastases.
3. Patients who have active or history of interstitial lung disease or noninfectious pneumonia.
4. Patients with QTc \> 450 ms in males and \> 470 ms in females on ECG at screening, or other clinically significant abnormalities in the ECG at the discretion of the investigator.
5. Patient with the Medication history and surgical history as stated in the protocol
6. Those who are unsuitable for blood collection or contraindicated for blood collection.
7. Other conditions considered unsuitable for participation in this trial at the discretion of the investigator.

Primary outcomes:
measure: The incidence and severity of adverse event (AE) of ICP-033 assessed by NCI-CTCAE V5.0.
timeFrame: through study completion, an average of 2 years
measure: Dose-Limiting Toxicities (DLTs)
timeFrame: through study completion, an average of 2 years
measure: Maximum tolerated dose (MTD)
timeFrame: through study completion, an average of 2 years
measure: Recommended phase II dose (RP2D)
timeFrame: through study completion, an average of 2 years
Secondary outcomes:
measure: The maximum plasma concentration observed (Cmax)
timeFrame: through study completion, an average of 2 years
measure: Time of maximum observed plasma concentration (Tmax)
timeFrame: through study completion, an average of 2 years
measure: Elimination half-life (t1/2)
timeFrame: through study completion, an average of 2 years
measure: Area under plasma concentration-time curve (AUC0-t and AUC0-∞)
timeFrame: through study completion, an average of 2 years
measure: Apparent clearance (CL/F)
timeFrame: through study completion, an average of 2 years
measure: Apparent volume of distribution (Vz/F)
timeFrame: through study completion, an average of 2 years
measure: The objective response rate (ORR)
timeFrame: through study completion, an average of 2 years
measure: Duration of response (DoR)
timeFrame: through study completion, an average of 2 years
measure: Progression-free survival (PFS)
timeFrame: through study completion, an average of 2 years
measure: Overall survival (OS)
timeFrame: through study completion, an average of 2 years
Other outcomes:
Locations:
city: Sichuan
country: China
facility: West China Hospital of Sichuan University
state: Chengdu
Study officials:
affiliation: West China Hospital
name: Feng Bi
role: PRINCIPAL_INVESTIGATOR
References: