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Advanced Solid TumorsPhase 1NCT04746612

First in Human Study to Evaluate the Safety, Tolerability of HH30134 in Advanced Solid Tumors

A Phase 1 study testing HH30134 in people with Advanced Solid Tumors, run by Haihe Biopharma Co., Ltd. at 4 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumors
What is being tested?
HH30134
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
4 sitesin 2 countries
Study dates
8 Apr 2021to 24 Mar 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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:
Show all 12Show fewer
  • 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.

Trial locations and contacts

4 sites in 2 countries.

4 sites in 2 countries

Australia2 sites

  • Blacktown Hospital

    Blacktown

  • Scientia Clinical Research

    Randwick

Other trials in Australia

China2 sites

  • Sun Yat-sen University Cancer Center

    Guangzhou

  • Fudan University Zhongshan Hospital

    Shanghai

Other trials in China

About this study

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

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.

Read the 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.

Being tested
HH30134

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HH30134Drug

    HH30134 administered orally on a continuous once daily(QD) in patients with advanced solid tumors

Study groups in NCT04746612
Study groupRoleWhat they receive
HH30134ExperimentalHH30134 administered orally on a continuous once daily(QD), start from 100mg QD.
Receives: Drug: HH30134

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose limiting toxicities(DLT)

    Incidence rate of dose limiting toxicities(DLT)

    Measured: 12 months

  2. Maximum Tolerated Dose

    To determine the maximum tolerable dose

    Measured: 12 months

Secondary outcomes (6)

  1. Pharmacokinetic(PK) measures - Plasma concentration-time Area Under the Curve

    Measure the HH30134 concentration in blood plasma as a function of time

    Measured: 12 months

  2. Pharmacokinetic(PK) measures - Cmax

    Measure the maximum plasma concentration of HH30134

    Measured: 12 months

  3. Pharmacokinetic(PK) measures - Tmax

    Measure of time to reach maximum plasma concentration after administration of HH30134

    Measured: 12 months

  4. Pharmacokinetic(PK) measures - CL/F

    Measure apparent total clearance of HH30134 from plasma after administration

    Measured: 12 months

  5. Pharmacokinetic(PK) measures - Vz/F

    Measure apparent volume of distribution during terminal phase after administration of HH30134

    Measured: 12 months

  6. Pharmacokinetic(PK) measures - terminal half-life(T1/2)

    Measure elimination half-life of HH30134

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2021
  2. Study start8 Apr 2021
  3. Primary completion24 Mar 2023
  4. Study completion24 Mar 2023

Why it stopped: Sponsor business decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04746612
Sponsor's protocol ID
HH30134-G101
Status last verified
Dec 2022
First submitted
19 Jan 2021
Last updated
30 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HH30134 in people with Advanced Solid Tumors, run by Haihe Biopharma Co., Ltd. at 4 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 30 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Australia, China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Sponsor business decision). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose limiting toxicities(DLT) (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04746612.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2023.

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