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A Clinical Trial of ICP-192 in Treated Patients With Advanced Solid Tumors With FGF/FGFR Gene Alterations

Sponsor
Beijing InnoCare Pharma Tech Co., Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05372120
Collaborator
(none)
200
Enrollment
1
Location
1
Arm
30.5
Anticipated Duration (Months)
6.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a phase II clinical trial in treated patients with advanced solid tumors with FGF/FGFR gene alterations. The purpose of this study is to evaluate the efficacy and safety of ICP-192.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Clinical Trial to Evaluate the Efficacy and Safety of ICP-192 in Treated Patients With Advanced Solid Tumors With FGF/FGFR Gene Alterations
Actual Study Start Date :
Dec 15, 2021
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Jun 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: ICP-192

20 mg once daily

Drug: ICP-192
ICP-192 is a round, uncoated tablet, 4mg, 5mg. It is administered orally at the dose of 20 mg/day from day 1 to day 21 of each cycle until progression

Outcome Measures

Primary Outcome Measures

  1. Objective response rate (ORR) [From the time of first dose until objective disease progression, an average of 6 months]

    ORR based on assessment of confirmed Complete response (CR) and partial response (PR) according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST).

Secondary Outcome Measures

  1. Duration of response (DOR) [From the time of first dose until objective disease progression, an average of 6 months]

    DOR is time interval from the first date that criteria for complete response or partial response are met to the first date of progression of disease

  2. Disease Control Rate (DCR) [From the time of first dose until objective disease progression, an average of 6 months]

    DCR based on assessment of confirmed Complete response (CR), partial response (PR) or stable disease(SD) according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST).

Other Outcome Measures

  1. Progression Free Survival (PFS) [From the time of first dose until objective disease progression, an average of 6 months]

    Progression free survival is the time period from start of study medication till the disease progression or death, whichever occurs first.

  2. Overall survival (OS) [From the time of first dose until objective disease progression, an average of 1 year]

    OS is the time period from start of study medication untill death from any cause.

Eligibility Criteria

Criteria

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

  1. Signed the ICF and Age ≥ 18 years old, either sex.

  2. ECOG ≤ 1.

  3. Life expectancy of at least 3 months.

  4. Part 1 (head and neck cancer cohort): Patients with HNC cancer who have failed or cannot tolerate standard therapy, and with FGF/FGFR gene alteration

  5. Part 2 (other solid tumor cohorts): Patients with other solid tumor who have failed or cannot tolerate standard therapy, and with FGF/FGFR gene alteration

  6. At least one measurable lesion as the target lesion at screening assessed according to RECIST V1.1 criteria.

Exclusion Criteria:

  1. Prior treatment with selective FGFR inhibitors or FGFR antibodies.

  2. Any corneal or retinal abnormalities that may result in an increased risk of ocular toxicity.

  3. Previously or currently endocrine alterations affecting the regulation of calcium-phosphorus homeostasis. History and/or current evidence of extensive tissue calcification.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Beijing Cancer Hospital Beijing Beijing China 100142

Sponsors and Collaborators

  • Beijing InnoCare Pharma Tech Co., Ltd.

Investigators

  • Principal Investigator: Ye Guo, Peking University Cancer Hospital & Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Beijing InnoCare Pharma Tech Co., Ltd.
ClinicalTrials.gov Identifier:
NCT05372120
Other Study ID Numbers:
  • ICP-CL-00304
First Posted:
May 12, 2022
Last Update Posted:
May 12, 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 12, 2022