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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05523947




Registration number
NCT05523947
Ethics application status
Date submitted
24/08/2022
Date registered
1/09/2022

Titles & IDs
Public title
Clinical Trial of YH32367 in Patients with HER2 Positive Locally Advanced or Metastatic Solid Tumor
Scientific title
A Phase 1/2, Open-label, Multicenter, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of YH32367 in Patients with HER2-Positive Locally Advanced or Metastatic Solid Tumors
Secondary ID [1] 0 0
YH32367-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HER2-Positive Solid Tumor 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - YH32367

Experimental: YH32367 - Dose Escalation Part: 8 Cohorts. In Dose Escalation part, patients are assigned to receive YH32367 at a starting dose and the dose being escalated/de-escalated in adjacent dose cohorts.

Dose Expansion Part: 2 Cohorts (Cohort 1: Biliary tract cancer, Cohort 2: Solid tumors). Dose Expansion part will consist of multiple cohorts in patients who were treated with at least 1 prior gemcitabine- and/or cisplatin-based therapy, HER2 positive biliary tract cancer(Cohort 1); in patients who were treated with all available standard therapies and have no available options, HER2 positive solid tumor malignancies other than breast and gastric or gastroesophageal junction adenocarcinoma and biliary tract cancer(Cohort 2).


Treatment: Drugs: YH32367
Dose Escalation Part: 8 Cohorts. In this part, approximately 30 patients will be enrolled and patients are assigned to receive YH32367 at a starting dose and the dose being escalated/de-escalated in adjacent dose cohorts will be up to Dose level 8.

Dose Expansion Part: 2 Cohorts(Cohort 1: Biliary tract cancer, Cohort 2: Solid tumors). The part will consist of multiple cohorts in patients who were treated with at least 1 prior gemcitabine- and/or cisplatin-based therapy, HER2 positive biliary tract cancer(Cohort 1); in patients who were treated with all available standard therapies and have no available options, HER2 positive solid tumor malignancies other than breast and gastric or gastroesophageal junction adenocarcinoma and biliary tract cancer(Cohort 2). Each cohort will enroll 65 and 40 patients, respectively.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Treatment-emergent adverse events (TEAEs) up to Day 21
Timepoint [1] 0 0
in dose escalation part, an average of 21 days
Primary outcome [2] 0 0
Objective Response Rate (ORR)
Timepoint [2] 0 0
through dose expansion part completion, approximately 2.5 year
Secondary outcome [1] 0 0
Area under the serum concentration-time curve from time 0 to the last quantifiable concentration (AUClast)
Timepoint [1] 0 0
up to 66 weeks
Secondary outcome [2] 0 0
maximum observed serum concentration (Cmax)
Timepoint [2] 0 0
up to 66 weeks
Secondary outcome [3] 0 0
time to reach Cmax (Tmax)
Timepoint [3] 0 0
up to 66 weeks
Secondary outcome [4] 0 0
Presence and characterization of YH32367 ADA in serum including titer of ADA and neutralizing antibodies
Timepoint [4] 0 0
through study completion, approximately 3.5 year
Secondary outcome [5] 0 0
Objective Response Rate (ORR)
Timepoint [5] 0 0
through study completion, approximately 3.5 year
Secondary outcome [6] 0 0
Duration of Response (DoR)
Timepoint [6] 0 0
through study completion, approximately 3.5 year
Secondary outcome [7] 0 0
Disease Control Rate (DCR)
Timepoint [7] 0 0
through study completion, approximately 3.5 year
Secondary outcome [8] 0 0
Depth of Response
Timepoint [8] 0 0
through study completion, approximately 3.5 year
Secondary outcome [9] 0 0
Time to Response
Timepoint [9] 0 0
through study completion, approximately 3.5 year
Secondary outcome [10] 0 0
Progression-free survival (PFS)
Timepoint [10] 0 0
through study completion, approximately 3.5 year
Secondary outcome [11] 0 0
TEAEs
Timepoint [11] 0 0
through dose expansion part completion, approximately 2.5 year
Secondary outcome [12] 0 0
Overall Survival (OS)
Timepoint [12] 0 0
through study completion, approximately 3.5 year

Eligibility
Key inclusion criteria
[Dose Escalation Part]

* Pathologically confirmed HER2-positive
* Mandatory provision of tumor tissue sample

[Dose Expansion Part]

* Patients who have at least one measurable lesion
* Mandatory provision of tumor tissue sample

1. Cohort 1: Pathologically confirmed HER2-positive biliary tract cancer
2. Cohort 2: Pathologically confirmed HER2-positive metastatic solid tumor malignancy other than breast and gastric or gastroesophageal junction adenocarcinoma and biliary tract cancer
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Uncontrolled central nervous system (CNS) metastases
* Spinal cord compression
* Carcinomatous meningitis
* Acute coronary syndromes
* Heart failure
* Interstitial lung disease (ILD)
* Pneumonitis
* History of a second primary cancer
* Human immunodeficiency virus (HIV)
* Active chronic hepatitis B
* Hepatitis C
* Systemic steroid therapy
* Autoimmune disease

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
26/08/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2026
Actual
Sample size
Target
137
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Southern Oncology Clinical Research Unit - Adelaide
Recruitment hospital [2] 0 0
Austin Health - Melbourne
Recruitment hospital [3] 0 0
Breast Cancer Research Centre - WA - Perth
Recruitment hospital [4] 0 0
Blacktown Hospital - Sydney
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Melbourne
Recruitment postcode(s) [3] 0 0
- Perth
Recruitment postcode(s) [4] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
Korea, Republic of
State/province [1] 0 0
Gyeonggi-do
Country [2] 0 0
Korea, Republic of
State/province [2] 0 0
Seoul

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Yuhan Corporation
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sun Young Rha
Address 0 0
Severance Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Clinical Operation Team 1
Address 0 0
Country 0 0
Phone 0 0
+82-2-828-0858
Fax 0 0
Email 0 0
clinicaltrials@yuhan.co.kr
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual participant data (including data dictionaries) that underline the results reported in study-related publications will be made available during the period beginning 1 year and ending 5 years after all trial primary and secondary endpoints were assessed. Only requests from researchers who provide a methodologically sound proposal will be reviewed and approved by the sponsor. The analysis type should be in accordance with aims in the proposal approved by the sponsor. Proposals should be directed to andrew90@yuhan.co.kr.

A summary of the study results will be posted in the publicly accessible database (i.e. clinicaltrials.gov) no later than 1 year after the study's primary completion date.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
Beginning 1 year and ending 5 years after all trial endpoints were assessed
Available to whom?
Only requests from researchers who provide a methodologically sound proposal will be reviewed and approved by the sponsor. The analysis type should be in accordance with aims in the proposal approved by the sponsor. Proposals should be directed to andrew90@yuhan.co.kr.
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05523947