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

A Phase I Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of ICP-033 in Patients With Solid Tumors

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.

Study Overview

• Status: Recruiting
• Conditions: Patients With Advanced Solid Tumors
• Intervention / Treatment: Drug: ICP-033 tablet

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Feng Bi; Phone Number: +86 028-85423203; Email: bifeng@medmail.com

Study Locations

• China
  • Chengdu
    • Sichuan, Chengdu, China, 610041
      • Recruiting
      • West China Hospital of Sichuan University
      • Contact: Feng Bi; Phone Number: +86 028-85423203; Email: bifeng@medmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ICP-033 Dose Escalation; Drug: ICP-033 tablet Administered orally，once a day，every 28 days is a cycle.	Drug: ICP-033 tablet; Administered orally, once a day, 28 days per cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence and severity of adverse event (AE) of ICP-033 assessed by NCI-CTCAE V5.0.	To assess the safety and tolerability of ICP-033 in patients with advanced solid tumors.	through study completion, an average of 2 years
Dose-Limiting Toxicities (DLTs)	To assess the safety and tolerability of ICP-033 in patients with advanced solid tumors.	through study completion, an average of 2 years
Maximum tolerated dose (MTD)	To assess the safety and tolerability of ICP-033 in patients with advanced solid tumors.	through study completion, an average of 2 years
Recommended phase II dose (RP2D)		through study completion, an average of 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The maximum plasma concentration observed (Cmax)	To evaluate the pharmacokinetic (PK) characteristics of ICP-033 in patients with solid tumors.	through study completion, an average of 2 years
Time of maximum observed plasma concentration (Tmax)	To evaluate the pharmacokinetic (PK) characteristics of ICP-033 in patients with solid tumors.	through study completion, an average of 2 years
Elimination half-life (t1/2)	To evaluate the pharmacokinetic (PK) characteristics of ICP-033 in patients with solid tumors.	through study completion, an average of 2 years
Area under plasma concentration-time curve (AUC0-t and AUC0-∞)	To evaluate the pharmacokinetic (PK) characteristics of ICP-033 in patients with solid tumors.	through study completion, an average of 2 years
Apparent clearance (CL/F)	To evaluate the pharmacokinetic (PK) characteristics of ICP-033 in patients with solid tumors.	through study completion, an average of 2 years
Apparent volume of distribution (Vz/F)	To evaluate the pharmacokinetic (PK) characteristics of ICP-033 in patients with solid tumors.	through study completion, an average of 2 years
The objective response rate (ORR)	To evaluate the preliminary anti-tumor activity of ICP-033.	through study completion, an average of 2 years
Duration of response (DoR)	To evaluate the preliminary anti-tumor activity of ICP-033.	through study completion, an average of 2 years
Progression-free survival (PFS)	To evaluate the preliminary anti-tumor activity of ICP-033.	through study completion, an average of 2 years
Overall survival (OS)	To evaluate the preliminary anti-tumor activity of ICP-033.	through study completion, an average of 2 years

Collaborators and Investigators

• Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.
• Investigators: Principal Investigator: Feng Bi, West China Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2022
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: April 24, 2022
• First Submitted That Met QC Criteria: May 8, 2022
• First Posted (Actual): May 10, 2022

Study Record Updates

• Last Update Posted (Actual): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: ICP-CL-00701

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No