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

Primary Purpose

Patients With Advanced Solid Tumors

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
ICP-033 tablet
Sponsored by
Beijing InnoCare Pharma Tech Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patients With Advanced Solid Tumors

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • West China Hospital of Sichuan UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ICP-033 Dose Escalation

Arm Description

Drug: ICP-033 tablet Administered orally，once a day，every 28 days is a cycle.

Outcomes

Primary Outcome Measures

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.
Dose-Limiting Toxicities (DLTs)
To assess the safety and tolerability of ICP-033 in patients with advanced solid tumors.
Maximum tolerated dose (MTD)
To assess the safety and tolerability of ICP-033 in patients with advanced solid tumors.
Recommended phase II dose (RP2D)

Secondary Outcome Measures

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

Full Information

First Posted
April 24, 2022
Last Updated
November 28, 2022
Sponsor
Beijing InnoCare Pharma Tech Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05367232
Brief Title
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

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 25, 2022 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing InnoCare Pharma Tech Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients With Advanced Solid Tumors

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ICP-033 Dose Escalation
Arm Type
Experimental
Arm Description
Drug: ICP-033 tablet Administered orally，once a day，every 28 days is a cycle.
Intervention Type
Drug
Intervention Name(s)
ICP-033 tablet
Intervention Description
Administered orally, once a day, 28 days per cycle
Primary Outcome Measure Information:
Title
The incidence and severity of adverse event (AE) of ICP-033 assessed by NCI-CTCAE V5.0.
Description
To assess the safety and tolerability of ICP-033 in patients with advanced solid tumors.
Time Frame
through study completion, an average of 2 years
Title
Dose-Limiting Toxicities (DLTs)
Description
To assess the safety and tolerability of ICP-033 in patients with advanced solid tumors.
Time Frame
through study completion, an average of 2 years
Title
Maximum tolerated dose (MTD)
Description
To assess the safety and tolerability of ICP-033 in patients with advanced solid tumors.
Time Frame
through study completion, an average of 2 years
Title
Recommended phase II dose (RP2D)
Time Frame
through study completion, an average of 2 years
Secondary Outcome Measure Information:
Title
The maximum plasma concentration observed (Cmax)
Description
To evaluate the pharmacokinetic (PK) characteristics of ICP-033 in patients with solid tumors.
Time Frame
through study completion, an average of 2 years
Title
Time of maximum observed plasma concentration (Tmax)
Description
To evaluate the pharmacokinetic (PK) characteristics of ICP-033 in patients with solid tumors.
Time Frame
through study completion, an average of 2 years
Title
Elimination half-life (t1/2)
Description
To evaluate the pharmacokinetic (PK) characteristics of ICP-033 in patients with solid tumors.
Time Frame
through study completion, an average of 2 years
Title
Area under plasma concentration-time curve (AUC0-t and AUC0-∞)
Description
To evaluate the pharmacokinetic (PK) characteristics of ICP-033 in patients with solid tumors.
Time Frame
through study completion, an average of 2 years
Title
Apparent clearance (CL/F)
Description
To evaluate the pharmacokinetic (PK) characteristics of ICP-033 in patients with solid tumors.
Time Frame
through study completion, an average of 2 years
Title
Apparent volume of distribution (Vz/F)
Description
To evaluate the pharmacokinetic (PK) characteristics of ICP-033 in patients with solid tumors.
Time Frame
through study completion, an average of 2 years
Title
The objective response rate (ORR)
Description
To evaluate the preliminary anti-tumor activity of ICP-033.
Time Frame
through study completion, an average of 2 years
Title
Duration of response (DoR)
Description
To evaluate the preliminary anti-tumor activity of ICP-033.
Time Frame
through study completion, an average of 2 years
Title
Progression-free survival (PFS)
Description
To evaluate the preliminary anti-tumor activity of ICP-033.
Time Frame
through study completion, an average of 2 years
Title
Overall survival (OS)
Description
To evaluate the preliminary anti-tumor activity of ICP-033.
Time Frame
through study completion, an average of 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; Patients with histologically confirmed locally advanced unresectable or metastatic solid tumors; At least one measurable lesion according to RECIST 1.1. Exclusion Criteria: 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. Patients with unstable primary central nervous system (CNS) tumors or CNS metastases. Patients who have active or history of interstitial lung disease or noninfectious pneumonia. 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. Patient with the Medication history and surgical history as stated in the protocol Those who are unsuitable for blood collection or contraindicated for blood collection. Other conditions considered unsuitable for participation in this trial at the discretion of the investigator.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Feng Bi
Phone
+86 028-85423203
Email
bifeng@medmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Feng Bi
Organizational Affiliation
West China Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
West China Hospital of Sichuan University
City
Sichuan
State/Province
Chengdu
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Feng Bi
Phone
+86 028-85423203
Email
bifeng@medmail.com

12. IPD Sharing Statement

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

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