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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04565275




Registration number
NCT04565275
Ethics application status
Date submitted
1/09/2020
Date registered
25/09/2020
Date last updated
14/03/2023

Titles & IDs
Public title
A Study of ICP-192 in Patients With Advanced Solid Tumors
Scientific title
A Multi-center Open-label, Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ICP-192 in Patients With Advanced Solid Tumors and FGFR Gene Alterations
Secondary ID [1] 0 0
ICP-CL-00303
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumors 0 0
Urothelial Carcinoma 0 0
Cholangiocarcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Biliary tree (gall bladder and bile duct)
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Drug ICP-192

Experimental: ICP-192 - 1. Dose Escalation Phase ICP-192
2. Dose Expansion Phase ICP-192


Treatment: Drugs: Drug ICP-192
1. Dose Escalation Phase ICP-192 will be taken by patients with advanced solid tumor and will be treated follow the "3+3" dose escalation scheme
2. Dose Expansion Phase ICP-192 will be taken by patients with urothelial carcinoma or cholangiocarcinoma with FGFR gene alterations and will be treated at a single dose defined from the Dose Escalation Phase.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Timepoint [1] 0 0
Up to 3 years
Primary outcome [2] 0 0
MTD
Timepoint [2] 0 0
Up to 3 years
Primary outcome [3] 0 0
OBD
Timepoint [3] 0 0
Up to 3 years
Primary outcome [4] 0 0
RP2D
Timepoint [4] 0 0
Up to 3 years
Primary outcome [5] 0 0
ORR
Timepoint [5] 0 0
Up to 3 years
Secondary outcome [1] 0 0
Peak concentration (Cmax)
Timepoint [1] 0 0
Up to 3 years
Secondary outcome [2] 0 0
AUC
Timepoint [2] 0 0
Up to 3 years
Secondary outcome [3] 0 0
DCR
Timepoint [3] 0 0
Up to 3 years
Secondary outcome [4] 0 0
DOR
Timepoint [4] 0 0
Up to 3 years
Secondary outcome [5] 0 0
PFS
Timepoint [5] 0 0
Up to 3 years
Secondary outcome [6] 0 0
OS
Timepoint [6] 0 0
Up to 3 years

Eligibility
Key inclusion criteria
Major Inclusion Criteria

Participants are eligible to be included in the study only if all of the following criteria apply:

1. Participate voluntarily, sign informed consent, and follow the study treatment plan and scheduled visits;
2. Phase I: Patients with histologically or cytologically confirmed unresectable or metastatic advanced malignant solid tumors who have progressed under standard treatment or recurred after or were intolerant to all standard treatment regimens, or have no standard treatment available;
3. Phase II: patients with histologically or cytologically confirmed unresectable or metastatic urothelial carcinoma or cholangiocarcinoma, who have progressed or recurred after or were intolerant to first-line chemotherapy, or have progressed/relapsed within 12 months after neoadjuvant /adjuvant chemotherapy;
4. Phase II: Existing test reports have confirmed the FGFR gene alteration or the central laboratory has detected the FGFR gene alteration.
5. Age =18 years old;
6. At least one measurable lesion according to the Response Evaluation Criteria of Solid Tumor, version 1.1 (RECIST 1.1);
7. ECOG performance status of 0-1;
8. Life expectancy for more than 3 months; Must have adequate organ function Major
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

Participants are excluded from the study if any of the following criteria apply:

1. Have previously been treated with selective pan-FGFR molecular inhibitors or antibody drugs, except for the FGFR4 selective inhibitors;
2. Within 2 weeks before the first dose of study drug, the subject's phosphate level continuing to exceed the ULN despite medical treatment;
3. Patients with clinically significant gastrointestinal dysfunction
4. Has known central nervous system metastases;
5. Has a history of or currently uncontrolled cardiovascular diseases
6. History of organ transplantation or a history of allogeneic hematopoietic stem cell transplantation;
7. Current evidence of corneal or retinal abnormalities that may increase eye toxicity;
8. Active hepatitis B virus active hepatitis C, or HIV infection;
9. Has not recovered from reversible toxicity of prior anti-tumor therapy
10. Pregnant or lactating women, as well as women with childbearing potential who are unwilling or unable to perform contraception from the screening to 6 months after the last study drug administration; and fertile men who are unwilling or unable to perform contraception from screening to 3months after the last study drug administration
11. Other conditions considered by the investigator to be inappropriate for participation in this study.

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

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/04/2024
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Macquarie University Hospital - Macquarie Park
Recruitment hospital [2] 0 0
GenesisCare - North Shore - St Leonards
Recruitment hospital [3] 0 0
Westmead Hospital - Westmead
Recruitment hospital [4] 0 0
Pindara Private Hospital - Benowa
Recruitment hospital [5] 0 0
Monash Medical Centre Clayton - Clayton
Recruitment hospital [6] 0 0
Peninsula & South Eastern Haematology & Oncology Group - Frankston
Recruitment hospital [7] 0 0
Olivia Newton-John Cancer Research Institute - Melbourne
Recruitment postcode(s) [1] 0 0
2109 - Macquarie Park
Recruitment postcode(s) [2] 0 0
1590 - St Leonards
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
4217 - Benowa
Recruitment postcode(s) [5] 0 0
3168 - Clayton
Recruitment postcode(s) [6] 0 0
3199 - Frankston
Recruitment postcode(s) [7] 0 0
3084 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Minnesota
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
Ohio
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Beijing InnoCare Pharma Tech Co., Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a multi-center, open-label, phase I/II clinical study to evaluate ICP-192 in patients with advanced solid tumors and FGFR gene alterations. It consists of two parts: Part I (Phase I), dose escalation and Part II (Phase II), dose expansion.
Trial website
https://clinicaltrials.gov/study/NCT04565275
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Olivia Yang
Address 0 0
Country 0 0
Phone 0 0
+1 (609) 524-0684
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04565275