NCT03160833

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
33

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started May 2017

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 19, 2017

Completed
4 days until next milestone

Study Start

First participant enrolled

May 23, 2017

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

February 13, 2020

Status Verified

February 1, 2020

Enrollment Period

2.6 years

First QC Date

May 17, 2017

Last Update Submit

February 12, 2020

Conditions

Solid Tumor, Adult

Keywords

HMPL453solid tumordose escalation

Outcome Measures

Primary Outcomes (1)

  • Incidence of DLTs by the NCI CTCAE v4.03

    Incidence of DLTs by the NCI CTCAE v4.03

    Cycle 1 (DLT assessment window 28 days)

Secondary Outcomes (12)

  • Incidence of AEs and clinically significant laboratory abnormalities

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

  • maximum plasma concentration (Cmax)

    From first dose to day 56 of multiple dosing period

  • time to reach maximum concentration (Tmax)

    From first dose to day 56 of multiple dosing period

  • terminal half-life (t1/2)

    From first dose to day 56 of multiple dosing period

  • area under the concentration-time curve (AUC0-t)

    From first dose to day 56 of multiple dosing period

  • +7 more secondary outcomes

Study Arms (1)

HMPL-453

EXPERIMENTAL

Two 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

Drug: HMPL-453

Interventions

HMPL-453DRUG

oral administrative

HMPL-453

Eligibility Criteria

Age25 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Prior or current treatment with any selective FGFR inhibitor.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Beijing 307 Hospital

Beijing, Beijing Municipality, 10000, China

Location

Cancer center of SYSU

Guangzhou, Guangdong, 510000, China

Location

Study Officials

  • Weiss Yang, Doctor

    HMPL

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Open-label, Multi-center, Dose Escalation Study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2017

First Posted

May 19, 2017

Study Start

May 23, 2017

Primary Completion

December 31, 2019

Study Completion

June 30, 2020

Last Updated

February 13, 2020

Record last verified: 2020-02

Locations

CN(2)