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

NCT05367232 | Recruiting Phase 1

• 1 other identifier: ICP-CL-00701
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Patients With Advanced Solid Tumors

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (10)

• The maximum plasma concentration observed (Cmax)

  through study completion, an average of 2 years

• Time of maximum observed plasma concentration (Tmax)

  through study completion, an average of 2 years

• Elimination half-life (t1/2)

  through study completion, an average of 2 years

• Area under plasma concentration-time curve (AUC0-t and AUC0-∞)

  through study completion, an average of 2 years

• Apparent clearance (CL/F)

  through study completion, an average of 2 years

Study Arms (1)

ICP-033 Dose Escalation

EXPERIMENTAL

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

Drug: ICP-033 tablet

Interventions

ICP-033 tablet DRUG

Administered orally, once a day, 28 days per cycle

ICP-033 Dose Escalation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing InnoCare Pharma Tech Co., Ltd.: lead

Study Sites (1)

West China Hospital of Sichuan University

Sichuan, Chengdu, 610041, China

RECRUITING

Study Officials

• Feng Bi

  West China Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Feng Bi

CONTACT

+86 028-85423203; bifeng@medmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2022
• First Posted: May 10, 2022
• Study Start: February 25, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: February 7, 2024

Record last verified: 2024-02

Locations

CN (1)