Clinical trial NCT04746612: First in Human Study to Evaluate the Safety, Tolerability of HH30134 in Advanced Solid Tumors
Official 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Advanced Solid Tumors
Lead sponsor: Haihe Biopharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-02-10
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and to determine the maximum tolerable dose (MTD) and/or recommended phase 2 dose (RP2D) of HH30134 administered orally on a continuous once daily (QD) schedule in adults patients with advanced solid tumors.

Detailed description: Study population

This is a global study involving multi-countries and multi-sites. Approximately 60 patients will be enrolled from participation institutions from different countries.

Enrollment in dose-escalation phase must have histologically or cytologically confirmed advanced solid tumors that have recurred or progressed following the last line of therapy and at least one prior standard of care regimens, or tumor for which there is no approved therapy, or for which standard therapy is unsuitable or refused. Enrollment in dose-expansion phase will be patients with selected solid tumors including but not limited to NSCLC and mCRC.

Eligibility criteria: 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

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.

Primary outcomes:
measure: Dose limiting toxicities(DLT)
timeFrame: 12 months
measure: Maximum Tolerated Dose
timeFrame: 12 months
Secondary outcomes:
measure: Pharmacokinetic(PK) measures - Plasma concentration-time Area Under the Curve
timeFrame: 12 months
measure: Pharmacokinetic(PK) measures - Cmax
timeFrame: 12 months
measure: Pharmacokinetic(PK) measures - Tmax
timeFrame: 12 months
measure: Pharmacokinetic(PK) measures - CL/F
timeFrame: 12 months
measure: Pharmacokinetic(PK) measures - Vz/F
timeFrame: 12 months
measure: Pharmacokinetic(PK) measures - terminal half-life(T1/2)
timeFrame: 12 months
Other outcomes:
Locations:
city: Blacktown
country: Australia
facility: Blacktown Hospital
city: Randwick
country: Australia
facility: Scientia Clinical Research
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
city: Shanghai
country: China
facility: Fudan University Zhongshan Hospital
Study officials:
affiliation: Haihe Biopharma
name: Yaling QI
role: STUDY_DIRECTOR
References: