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

NCT ID: NCT05367232

Last Updated: 2024-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-25

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Patients With Advanced Solid Tumors

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ICP-033 Dose Escalation

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

Group Type EXPERIMENTAL

ICP-033 tablet

Intervention Type DRUG

Administered orally, once a day, 28 days per cycle

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ICP-033 tablet

Administered orally, once a day, 28 days per cycle

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Beijing InnoCare Pharma Tech Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Feng Bi

Role: PRINCIPAL_INVESTIGATOR

West China Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

West China Hospital of Sichuan University

Sichuan, Chengdu, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Feng Bi

Role: CONTACT

+86 028-85423203

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Feng Bi

Role: primary

+86 028-85423203

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ICP-CL-00701

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.