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Solid Tumor, AdultPhase 1/2NCT03160833

A Study of HMPL-453 in Patients With Advanced Solid Malignancies

A Phase 1/2 study testing HMPL-453 in people with Solid Tumor, Adult, run by Hutchison Medipharma Limited at 2 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a dose escalation study consisting of two stages: Dose-escalation stage (stage 1): Patients will take a single dose of HMPL-453 on Day 1 and will be followed for one week for safety observations. Read more about this study

Who is it for?
Ages 25 years and older
Conditions the study is for
Solid Tumor, Adult
What is being tested?
HMPL-453
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
2 sitesChina
Study dates
23 May 2017to 30 Jun 2020
Phase
Phase 1/2
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 25 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • In the dose escalation stage, patients with locally advanced, or metastatic solid tumor who have failed, or intolerable to, standard therapies or for whom no standard therapies exist will be enrolled.
  • In the dose expansion stage, patients with locally advanced, or metastatic solid tumor and FGFR dysregulation who have failed or intolerable to standard therapies or no standard therapies exist are to be enrolled.
  • In the dose escalation stage: evaluable or measurable disease according to RECIST Version 1.1. In the dose expansion stage: measurable disease according to RECIST Version 1.1.
  • Life expectancy of at least 12 weeks.
  • ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1.

Who cannot join

  • Prior or current treatment with any selective FGFR inhibitor.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Beijing 307 Hospital

    Beijing, Beijing Municipality, 10000

  • Cancer center of SYSU

    Guangzhou, Guangdong, 510000

Other trials in China

About this study

Official title: A Phase I/II, Open-label, Multi-center, Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of HMPL-453 in Patients With Advanced Solid Malignancies

This is a dose escalation study consisting of two stages: Dose-escalation stage (stage 1): Patients will take a single dose of HMPL-453 on Day 1 and will be followed for one week for safety observations. After one week of observation, if no safety issues occur, patients can continue multiple dosing of HMPL-453 QD (quaque die) and start on the DLT (Dose Limited Toxicity) assessment cycles. Each cycle consists of 28-days. Patients are required to draw blood samples for PK and safety analysis at specific time points during the treatment; Dose-Expansion Stage (Stage 2): This stage is to further evaluate the safety, tolerability, PD (pharmacodynamics) profile, and preliminary anti-tumor activity of HMPL-453 at the RP2D (recommended phase 2 dose) in approximately 10 patients with advanced solid tumor.

Read the detailed description

Dose-escalation stage (stage 1): Patients participating in the dose-escalation stage will take a single dose of HMPL-453 on Day 1 and will be followed for one week for safety observations. After one week of observation, if no safety issues occur, patients can continue multiple dosing of HMPL-453 QD and start on the DLT assessment cycles. Each cycle consists of 28-days. Patients are required to draw blood samples for PK and safety analysis at specific time points during the treatment.

The 3+3 design will be employed for the dose escalation and MTD ( maximum tolerated dose) determination. To limit the number of patients being exposed to potentially ineffective doses, one patient will be enrolled and dosed in the initial dose cohort. If there are no DLT or less than grade 2 toxicities of Common Terminology Criteria for Adverse Event ( CTC AE ) occur in the first treatment cycle, then the study will be escalated to the next dose cohort. Otherwise, the trial will revert to a standard 3+3 design.

Dose-Expansion Stage (Stage 2): This stage is to further evaluate the safety, tolerability, pharmacokinetics (PK) profile, and preliminary anti-tumor activity of HMPL-453 at the RP2D in approximately 60 patients with advanced solid tumor. Patients with FGFR ( Fibroblast Growth Factor Receptor) dysregulated advanced solid tumors, including but not limited to advanced urothelial bladder cancer, advanced cholangiocarcinoma (patients with cancers of the gallbladder or ampulla of Vater are not eligible) and others solid tumors are preferred to be enrolled.

Expansion stage will begin after dose-escalation stage is completed and the MTD/RP2D has been determined. Patients will receive HMPL-453 with 28-day treatment cycles until disease progression, death, intolerable toxicity, no longer benefiting from the study treatment per investigator's discretion, or withdrawal of consent, whichever comes first.

Being tested
HMPL-453
Keywords
HMPL453, solid tumor, dose escalation

What participants receive

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

  • HMPL-453Drug

    oral administrative

Study groups in NCT03160833
Study groupRoleWhat they receive
HMPL-453ExperimentalTwo strengths of HMPL-453 tablets (25 mg and 100 mg based on the free base) will be used for clinical studies. The drug products are coated tablets, which are packaged in white induction sealed HDPE (high-density polyethylene) bottles. HMPL-453 will be administered to patients as oral tablet(s) on a daily basis, until disease progression, intolerable toxicity, or death. Dose levels are to be potentially tested in this study include 50, 100, 200, 300, 400, and 500 mg/day
Receives: Drug: HMPL-453

What is being measured

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

  1. Incidence of DLTs by the NCI CTCAE v4.03

    Incidence of DLTs by the NCI CTCAE v4.03

    Measured: Cycle 1 (DLT assessment window 28 days)

Secondary outcomes (12)

  1. Incidence of AEs and clinically significant laboratory abnormalities

    incidence of any AEs associated to treatment

    Measured: From first dose to 30 days after last dose of study treatment

  2. maximum plasma concentration (Cmax)

    maximum plasma concentration (Cmax) of HMP 453

    Measured: From first dose to day 56 of multiple dosing period

  3. time to reach maximum concentration (Tmax)

    time to reach maximum concentration (Tmax) of HMP 453

    Measured: From first dose to day 56 of multiple dosing period

  4. terminal half-life (t1/2)

    terminal half-life (t1/2) of HMP-453

    Measured: From first dose to day 56 of multiple dosing period

  5. area under the concentration-time curve (AUC0-t)

    area under the concentration-time curve (AUC0-t) of HMP453

    Measured: From first dose to day 56 of multiple dosing period

  6. apparent clearance (CL/F)

    apparent clearance (CL/F) of HMP 453

    Measured: From first dose to day 56 of multiple dosing period

  7. Serum phosphate level increases

    to evaluate the fluctuate level of Serum phosphate level

    Measured: From first dose to Day 21 of the last treatment cycle

  8. Objective response rate (ORR)

    per RECIST

    Measured: Every 8 weeks while being treated with HMPL-453 (expected average of 16 weeks)

  9. Duration of response (DoR)

    from the date of response to progress or death

    Measured: Every 8 weeks while being treated with HMPL-453 (expected average of 16 weeks)

  10. Disease Control Rate (DCR)

    the response rate of PR (partial response) +CR(complete response) +SD （stable disease）

    Measured: Every 8 weeks while being treated with HMPL-453 (expected average of 16 weeks)

  11. Change in tumor size

    per RECIST to evaluate the change of target and non-target lesions

    Measured: Every 8 weeks while being treated with HMPL-453 (expected average of 16 weeks)

  12. Progression free survival (PFS)

    Per RECIST 1.1

    Measured: Every 8 weeks while being treated with HMPL-453 (expected average of 16 weeks)

Timeline

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

  1. First posted19 May 2017
  2. Study start23 May 2017
  3. Primary completion31 Dec 2019
  4. Study completion30 Jun 2020 (estimated)

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Open-label, Multi-center, Dose Escalation Study
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03160833
Sponsor's protocol ID
2015-453-00CH1
Status last verified
Feb 2020
First submitted
17 May 2017
Last updated
13 Feb 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing HMPL-453 in people with Solid Tumor, Adult, run by Hutchison Medipharma Limited at 2 sites in China.

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 5 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 13 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

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?

Incidence of DLTs by the NCI CTCAE v4.03 (time frame: Cycle 1 (DLT assessment window 28 days)). 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 NCT03160833.

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 13 Feb 2020.

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