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

• Sponsor: Beijing InnoCare Pharma Tech Co., Ltd. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05367232
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 45.2
• Patients Per Site Per Month: 1.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Patients With Advanced Solid Tumors	Drug: ICP-033 tablet	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase I Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of ICP-033 in Patients With Solid Tumors
• Actual Study Start Date: Feb 25, 2022
• Anticipated Primary Completion Date: Dec 1, 2024
• Anticipated Study Completion Date: Dec 1, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

3. 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

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. The objective response rate (ORR) [through study completion, an average of 2 years]

   To evaluate the preliminary anti-tumor activity of ICP-033.

8. Duration of response (DoR) [through study completion, an average of 2 years]

   To evaluate the preliminary anti-tumor activity of ICP-033.

9. Progression-free survival (PFS) [through study completion, an average of 2 years]

   To evaluate the preliminary anti-tumor activity of ICP-033.

10. Overall survival (OS) [through study completion, an average of 2 years]

    To evaluate the preliminary anti-tumor activity of ICP-033.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	West China Hospital of Sichuan University	Sichuan	Chengdu	China	610041

Sponsors and Collaborators

• Beijing InnoCare Pharma Tech Co., Ltd.

Investigators

• Principal Investigator: Feng Bi, West China Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Beijing InnoCare Pharma Tech Co., Ltd.
• ClinicalTrials.gov Identifier: NCT05367232
• Other Study ID Numbers: ICP-CL-00701
• First Posted: May 10, 2022
• Last Update Posted: May 10, 2022
• Last Verified: Apr 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Neoplasms

Study Results

No Results Posted as of May 10, 2022