Clincosm LogoSign in Get a demo

An Efficacy and Safety Study of ICP-192 in Subjects With Bladder Urothelial Cancer

Sponsor
Beijing InnoCare Pharma Tech Co., Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04492293
Collaborator
(none)
95
Enrollment
10
Locations
1
Arm
31.1
Anticipated Duration (Months)
9.5
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a phase 2, multicenter, single arm, open-lable study of ICP-192. The purpose of this study is to evaluate efficacy of ICP-192 in subjects with surgically unresectable or metastatic bladder urothelial cancer.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

bladder urothelial cancer

Study Design

Study Type:
Interventional
Anticipated Enrollment :
95 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 2, Multicenter, Single Arm, Open-lable Study of ICP-192 in Subjects With Surgically Unresectable or Metastatic Bladder Urothelial Cancer With FGFR Genetic Aberrations.
Actual Study Start Date :
May 27, 2020
Anticipated Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Dec 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: ICP-192

ICP-192

Drug: ICP-192
ICP-192 is a white, round, uncoated table

Outcome Measures

Primary Outcome Measures

  1. ORR [Up to 3 years]

    Objective Response Rate

Secondary Outcome Measures

  1. DOR [Up to 3 years]

    Duration of response

  2. DCR [Up to 3 years]

    Disease Control Rate

  3. PFS [Up to 3 years]

    Progression Free Survival

  4. OS [From the time of first dose until death from any cause, assessed up to 3 years]

    Overall survival

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

Inclusion criteria：

  • Volunteer to enroll and sign informed consent form

  • Male or female aged at least 18 years

  • ECOG performance status score 0 or 1

  • The expected survival time is more than 3 months

  • Histologically confirmed unresectable or metastatic bladder urothelial cancinoma.

  • Must have measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1) at baseline.

Exclusion Criteria:

  • Previous treatment with FGFR small molecule inhibitors or antibody drugs.

  • Blood phosphate persistently above ULN within two weeks of the first administration of study drug, and despite medical management.

  • Central nervous system (CNS) metastasis

  • Has not recovered from reversible toxicity of prior anticancer therapy

  • Has a history of or current uncontrolled cardiovascular disease

  • Has impaired wound healing capacity defined as skin/decubitus ulcers, chronic leg ulcers, known gastric ulcers, or unhealed incisions

  • Any corneal or retinal abnormality likely to increase the risk of eye toxicity

  • Known active infection with HBV, HCV or HIV.

  • Lactating or pregnant women, or women who will not use contraception during the study and for 180 days after the last dose of study drug if sexually active and able to bear children.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Contacts and Locations

Locations

Site City State Country Postal Code
1 The First Affiliated Hospital of Anhui Medical University Hefei Anhui China
2 Lanzhou University Second Hospital Lanzhou Gansu China
3 Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology Wuhan Hubei China
4 Liaoning Cancer Hospital & Institute Shenyang Liaoning China
5 Qilu Hospital of Shandong University Jinan Shandong China
6 First Hospital of Shanxi Medical University Taiyuan Shanxi China
7 The First Affiliated Hospital, College of Medicine, Zhejiang University Hangzhou Zhejiang China
8 Beijing Cancer Hospital Beijing China
9 The Second Hospital of Tianjin Medical University Tianjin China
10 Tianjin Medical University Cancer Institute & Hospital Tianjin China

Sponsors and Collaborators

  • Beijing InnoCare Pharma Tech Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Beijing InnoCare Pharma Tech Co., Ltd.
ClinicalTrials.gov Identifier:
NCT04492293
Other Study ID Numbers:
  • ICP-CL-00302
First Posted:
Jul 30, 2020
Last Update Posted:
Oct 22, 2021
Last Verified:
Oct 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Oct 22, 2021