Patients With Advanced Solid Tumors
Conditions
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.
Interventions
DRUGICP-033 tablet
Administered orally, once a day, 28 days per cycle
Sponsors
Beijing InnoCare Pharma Tech Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence and severity of adverse event (AE) of ICP-033 assessed by NCI-CTCAE V5.0. | through study completion, an average of 2 years | To assess the safety and tolerability of ICP-033 in patients with advanced solid tumors. |
| Dose-Limiting Toxicities (DLTs) | through study completion, an average of 2 years | To assess the safety and tolerability of ICP-033 in patients with advanced solid tumors. |
| Maximum tolerated dose (MTD) | through study completion, an average of 2 years | To assess the safety and tolerability of ICP-033 in patients with advanced solid tumors. |
| Recommended phase II dose (RP2D) | through study completion, an average of 2 years | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Apparent clearance (CL/F) | through study completion, an average of 2 years | To evaluate the pharmacokinetic (PK) characteristics of ICP-033 in patients with solid tumors. |
| Apparent volume of distribution (Vz/F) | through study completion, an average of 2 years | To evaluate the pharmacokinetic (PK) characteristics of ICP-033 in patients with solid tumors. |
| The objective response rate (ORR) | through study completion, an average of 2 years | To evaluate the preliminary anti-tumor activity of ICP-033. |
| The maximum plasma concentration observed (Cmax) | through study completion, an average of 2 years | To evaluate the pharmacokinetic (PK) characteristics of ICP-033 in patients with solid tumors. |
| Progression-free survival (PFS) | through study completion, an average of 2 years | To evaluate the preliminary anti-tumor activity of ICP-033. |
| Overall survival (OS) | through study completion, an average of 2 years | To evaluate the preliminary anti-tumor activity of ICP-033. |
| Duration of response (DoR) | through study completion, an average of 2 years | To evaluate the preliminary anti-tumor activity of ICP-033. |
| Time of maximum observed plasma concentration (Tmax) | through study completion, an average of 2 years | To evaluate the pharmacokinetic (PK) characteristics of ICP-033 in patients with solid tumors. |
| Elimination half-life (t1/2) | through study completion, an average of 2 years | To evaluate the pharmacokinetic (PK) characteristics of ICP-033 in patients with solid tumors. |
| Area under plasma concentration-time curve (AUC0-t and AUC0-∞) | through study completion, an average of 2 years | To evaluate the pharmacokinetic (PK) characteristics of ICP-033 in patients with solid tumors. |
Countries
China
Contacts
Primary ContactFeng Bi
Outcome results
None listed