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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04746612




Registration number
NCT04746612
Ethics application status
Date submitted
19/01/2021
Date registered
10/02/2021

Titles & IDs
Public title
First in Human Study to Evaluate the Safety, Tolerability of HH30134 in Advanced Solid Tumors
Scientific title
A Phase I, Multi-centre, Open-Label, First in Human Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HH30134 in Patients With Advanced Solid Tumours
Secondary ID [1] 0 0
HH30134-G101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - HH30134

Experimental: HH30134 - HH30134 administered orally on a continuous once daily(QD), start from 100mg QD.


Treatment: Drugs: HH30134
HH30134 administered orally on a continuous once daily(QD) in patients with advanced solid tumors
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Dose limiting toxicities(DLT)
Timepoint [1] 0 0
12 months
Primary outcome [2] 0 0
Maximum Tolerated Dose
Timepoint [2] 0 0
12 months
Secondary outcome [1] 0 0
Pharmacokinetic(PK) measures - Plasma concentration-time Area Under the Curve
Timepoint [1] 0 0
12 months
Secondary outcome [2] 0 0
Pharmacokinetic(PK) measures - Cmax
Timepoint [2] 0 0
12 months
Secondary outcome [3] 0 0
Pharmacokinetic(PK) measures - Tmax
Timepoint [3] 0 0
12 months
Secondary outcome [4] 0 0
Pharmacokinetic(PK) measures - CL/F
Timepoint [4] 0 0
12 months
Secondary outcome [5] 0 0
Pharmacokinetic(PK) measures - Vz/F
Timepoint [5] 0 0
12 months
Secondary outcome [6] 0 0
Pharmacokinetic(PK) measures - terminal half-life(T1/2)
Timepoint [6] 0 0
12 months

Eligibility
Key inclusion criteria
* Provision of signed and dated informed consent form.
* Stated willingness to comply with all study procedures and availability for the duration of the study.
* Male and female patients = 18 years of age (or having reached the age of majority according to local laws and regulations, if the age is > 18 years)
* Patients must have histologically or cytologically confirmed advanced solid tumors
* Predicted life expectancy of = 3 months
* Eastern Cooperative Oncology Group (ECOG) performance status = 1
* Availability of archival tissue within three years or fresh tumor biopsy sample
* Patients must have adequate hepatic and renal function
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patient has received any anticancer therapy (including chemotherapy, targeted therapy, hormonal therapy, biotherapy, immunotherapy, or other investigational agents.) within 28 days or 5 times of half-lives (whichever is shorter) prior to the first dose of the study treatment.
* Radical radiation therapy (including radiation therapy for over 25% bone marrow) within 4 weeks prior to the first dose of the investigational product or received local palliative radiation therapy for bone metastases within 2 weeks.
* Any toxicities from prior treatment that have not recovered to baseline or = CTCAE v5.0 Grade 1 before the start of study treatment, with exception of hair loss.
* Patients who have symptomatic CNS metastasis which is neurologically unstable or those who have CNS disease requiring increase in the dose of steroid.
* Major surgery or had significant traumatic injury within 28 days prior to the first dose of the investigational product or has not recovered from major side effects.
* Known HIV infection with a history of acquired immunodeficiency syndrome (AIDS)- defining opportunity infection within the past 12months; active hepatitis B and hepatitis C. Patients whose test results meet one of the following will not be enrolled:
* Patient is currently receiving or has received systemic corticosteroids = 2 weeks prior to starting study treatment, or who have not fully recovered from side effects of such treatment.
* Gastrointestinal condition which could impair absorption of study medication.
* Patients with clinically significant cardiovascular disease
* Any diseases or medical conditions, at the Investigator's discretion, that may be unstable or influence their safety or study compliance, including organ transplantation, abuse of psychotropic medication, alcohol abuse or history of drug abuse.
* Other serious illness or medical conditions at the Investigator's discretion, that may influence study results, including but not limited to serious infection, diabetes, cardiovascular and cerebrovascular diseases or lung disease.
* Pregnant or breast-feeding patients. Pregnancy refers to the state of a woman between fertilization and the end of pregnancy confirmed by a positive laboratory hCG test (> 5 mIU/mL). Breast-feeding woman can become eligible for this study if she stops breast-feeding, however, cannot restart the breast-feeding on/after the completion of the study treatment.

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
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/04/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
24/03/2023
Sample size
Target
Accrual to date
Final
22
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Blacktown Hospital - Blacktown
Recruitment hospital [2] 0 0
Scientia Clinical Research - Randwick
Recruitment postcode(s) [1] 0 0
- Blacktown
Recruitment postcode(s) [2] 0 0
- Randwick
Recruitment outside Australia
Country [1] 0 0
China
State/province [1] 0 0
Guangzhou
Country [2] 0 0
China
State/province [2] 0 0
Shanghai

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Haihe Biopharma Co., Ltd.
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Yaling QI
Address 0 0
Haihe Biopharma
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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/NCT04746612