A Study of ICP-033 in Patients With Advanced Solid Tumors

Phase 1

Recruiting

• Conditions: Patients With Advanced Solid Tumors
• Interventions: Drug: ICP-033 tablet

• Registration Number: NCT05367232
• Lead Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-25
• Study First Submitted: 2022-04-24
• Study First Submitted QC: 2022-05-08
• Study First Posted: 2022-05-10
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-05
• Last Update Posted: 2024-02-07
• Primary Completion: 2024-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ICP-033 Dose Escalation	ICP-033 tablet	Drug: ICP-033 tablet Administered orally，once a day，every 28 days is a cycle.

Primary Outcome Measures

Name	Time	Method
Recommended phase II dose (RP2D)	through study completion, an average of 2 years
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.

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS)	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.
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.
The objective response rate (ORR)	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.
Progression-free survival (PFS)	through study completion, an average of 2 years	To evaluate the preliminary anti-tumor activity of ICP-033.
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.

Trial Locations

Locations (1)

West China Hospital of Sichuan University; 🇨🇳 Sichuan, Chengdu, China