A Study of DBPR112 in Patients With Head and Neck Cancer and EGFR Mutated Lung Cancer

December 15, 2020 updated by: National Health Research Institutes, Taiwan

Phase I, Open-Label, Multiple Dose, Dose-Finding and Expansion Clinical Study to Assess the Safety, Pharmacokinetics, and Efficacy of DBPR112 in Patients With Head and Neck Cancer and EGFR Mutated Lung Cancer

The study is being performed to assess the MTD, pharmacokinetics (PK), safety, tolerability and preliminary antitumor activity of DBPR112 in patients with head and neck cancer and EGFR mutated lung cancer.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a Phase I, multi-center, open-label, first-in-human study to determine the MTD and RP2D of DBPR112 and to assess the safety, tolerability and PK of DBPR112 in Asian patients. Patients with non-small cell cancer (NSCLC) who have progressed following prior therapy with an epidermal growth factor receptor (EGFR) tyrosine kinase (TK) inhibitor or in patients with squamous cell cancer of head and neck (SCCHN) who have progressed following prior standard therapy will be selected. Approximately 24 to 30 patients will be enrolled in this study as out patients/inpatients, in 2 study centers in Taiwan.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 110
        • Taipei Medical University Hospital
      • Taipei, Taiwan, 10048
        • National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and female patients
  • Age from ≥18 to ≤70 years
  • Life expectancy >12 weeks per investigator's judgement
  • Squamous cell carcinoma of head and neck that has failed prior standard therapy for metastatic disease or advanced EGFR-mutated NSCLC that has failed prior standard therapy including at least one anti EGFR TK inhibitor
  • Non-measurable but evaluable disease, or measurable disease per RECIST 1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate blood and organ function
  • Male and female patients must agree to use contraception while on study and for 90 days after the last dose of DBPR112
  • Aspartate aminotransferase/ALT <3 X ULN if no metastasis, and AST/ALT <5 X ULN in presence of metastasis

Exclusion Criteria:

  • History of allergic reactions to any component of DBPR112
  • History of unstable central nervous system (CNS) metastases or seizure disorder related to the malignancy; however, those patients who were treated for prior CNS metastases and who are asymptomatic may participate in the study
  • History of congestive heart failure, unstable angina pectoris, unstable atrial fibrillation, or cardiac arrhythmia
  • Exposure to any other investigational or commercial anticancer agents or therapies administered with the intention to treat malignancy within 28 days for chemotherapeutics and targeted agents, or 5 half-lives for proteins, whichever is longer, before the first dose of DBPR112
  • Significant surgical intervention within 21 days of the first dose of DBPR112 or with ongoing postoperative complications
  • Chronic skin condition that requires prescribed oral or intravenous treatment
  • History of severe rash that required discontinuation of prior EGFR targeted therapy
  • History of interstitial lung disease or non-infectious pneumonitis except for those induced by radiation therapy
  • Toxicities from any prior therapy, surgery, or radiotherapy must have resolved to Grade 0 or 1 as per the National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 or equivalent

  • Insufficient organ function as indicated by the following parameters

    1. Absolute neutrophil count (ANC) <1,500 /µL
    2. Platelets <100,000 /µL
    3. Hemoglobin <10 g/dL
    4. Serum creatinine >1.5 X ULN
    5. Serum total bilirubin >1.5 X ULN
    6. Aspartate aminotransferase/ALT >3 X ULN if no metastasis, AST/ALT >5 X ULN in presence of metastasis
    7. International normalized ratio or prothrombin time >1.5 X ULN
  • Known history of human immunodeficiency virus (HIV)1 or 2
  • Active clinically significant infection requiring systemic therapy
  • Positive test for hepatitis B (HBsAg) or hepatitis C (anti-HCV antibody)
  • Child-Pugh B & C stage liver disease or liver function impairment
  • Underlying medical conditions that, in the Investigator's opinion, will make the administration of DBPR112 hazardous or obscure the interpretation of toxicity or AEs
  • Inability to swallow oral medications (capsules and tablets) without chewing, breaking, crushing, opening or otherwise altering the product formulation. Patients should not have gastrointestinal illnesses that would preclude the absorption of DBPR112, which is an oral agent
  • Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements
  • Pregnancy or breastfeeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: DBPR112
Drug: DBPR112
DBPR112 hard gelatin capsule solid dosage formulation; strength: 25 mg, 100 mg.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Maximum Tolerated Dose (MTD)
Time Frame: up to 22 months
up to 22 months
Area Under the Plasma Concentration-Time Curve (AUC from 0 to infinity)
Time Frame: For Cycle 1 (each cycle is 28 days) and Cycle 2, Day 1, predose (0 hr), 0.5, 1, 2, 3, 4, 6, 8 and 24 hrs (i.e. predose on Day 2).Predose samples on Cycle 1 Days 8, 15, 22, and 28, Cycle 2 Day 15, and Cycle3-6 Days 1 and 15.
For Cycle 1 (each cycle is 28 days) and Cycle 2, Day 1, predose (0 hr), 0.5, 1, 2, 3, 4, 6, 8 and 24 hrs (i.e. predose on Day 2).Predose samples on Cycle 1 Days 8, 15, 22, and 28, Cycle 2 Day 15, and Cycle3-6 Days 1 and 15.
Observed Maximum Plasma Concentration (Cmax)
Time Frame: For Cycle 1 (each cycle is 28 days) and Cycle 2, Day 1, predose (0 hr), 0.5, 1, 2, 3, 4, 6, 8 and 24 hrs (i.e. predose on Day 2).Predose samples on Cycle 1 Days 8, 15, 22, and 28, Cycle 2 Day 15, and Cycle3-6 Days 1 and 15.
For Cycle 1 (each cycle is 28 days) and Cycle 2, Day 1, predose (0 hr), 0.5, 1, 2, 3, 4, 6, 8 and 24 hrs (i.e. predose on Day 2).Predose samples on Cycle 1 Days 8, 15, 22, and 28, Cycle 2 Day 15, and Cycle3-6 Days 1 and 15.
Time of Maximum Plasma Concentration (tmax)
Time Frame: For Cycle 1 (each cycle is 28 days) and Cycle 2, Day 1, predose (0 hr), 0.5, 1, 2, 3, 4, 6, 8 and 24 hrs (i.e. predose on Day 2).Predose samples on Cycle 1 Days 8, 15, 22, and 28, Cycle 2 Day 15, and Cycle3-6 Days 1 and 15.
For Cycle 1 (each cycle is 28 days) and Cycle 2, Day 1, predose (0 hr), 0.5, 1, 2, 3, 4, 6, 8 and 24 hrs (i.e. predose on Day 2).Predose samples on Cycle 1 Days 8, 15, 22, and 28, Cycle 2 Day 15, and Cycle3-6 Days 1 and 15.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Incidence and intensity of Adverse Events and Serious Adverse Events as a measure of safety
Time Frame: Adverse events were collected from the time of the first dose of investigational product until 30 days after the last dose of investigational product administration.
Adverse events were collected from the time of the first dose of investigational product until 30 days after the last dose of investigational product administration.
Preliminary antitumor activity of DBPR112 in patients with solid tumors
Time Frame: The tumor responses were collected from the time of the first dose of investigational product until 30 days after the last dose of investigational product administration.
The tumor responses were collected from the time of the first dose of investigational product until 30 days after the last dose of investigational product administration.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Health Research Institutes, Taiwan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 18, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 4, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 4, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 7, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 8, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 11, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 17, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 15, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DBPR112-101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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