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A Study of the Oral EGFR Inhibitor PLB1004 in Non-Small Cell Lung Cancer

Primary Purpose

Non-Small Cell Lung Cancer

Status
Not yet recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PLB1004
Sponsored by
Avistone Biotechnology Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Ability to understand and willingness to sign a written informed consent document; Male or female adult patients 18 years of age or older; Patients should have recovered from toxicities related to prior anti-tumor therapy; Patients should have recovered from the effects of major surgery; Have a documented EGFR in-frame exon 20 insertion mutation by a local test in tissue or plasma; At least 12 weeks life expectancy; Must have at least one measurable lesion per RECIST v 1.1; Sexually active males and females of childbearing potential must agree to take effective contraceptive measures. Exclusion Criteria: Received radiotherapy within 14 days before enrollment; Have significant or uncontrolled systemic disease; Have significant or uncontrolled cardiovascular disease; Have had other diagnosed malignant diseases that required treatment within the past 3 years besides NSCLC; Currently have or had a history of interstitial lung disease, drug-induced interstitial lung disease, or radiation pneumonia that requires steroid therapy; Have known hypersensitivity to the similar drugs and excipients of PLB1004; Pregnant or lactating women; Have used other experimental drugs within 2 weeks prior to the first dose of PLB1004; Have any condition or illness that could affect the compliance with the protocol.

Sites / Locations

  • Nebraska Cancer Specialists

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PLB1004

Arm Description

PLB1004 given as a mono-therapy in dose escalation and dose expansion phase.

Outcomes

Primary Outcome Measures

Safety profile of PLB1004 per CTCAE v5.0

Secondary Outcome Measures

To define the DLTs and MTD
Area Under the Curve (AUC) of PLB1004
Maximum plasma concentration (Cmax) of PLB1004
Time to maximum plasma concentration (Tmax) of PLB1004
Overall Response Rate (ORR)
Progression-Free Survival (PFS)
Overall Survival (OS)
Disease Control Rate (DCR)
Duration of Response (DOR)
Change from baseline in corrected QT interval (QTc) using Fridericia formula (QTcF)

Full Information

First Posted
September 6, 2023
Last Updated
September 19, 2023
Sponsor
Avistone Biotechnology Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT06046495
Brief Title
A Study of the Oral EGFR Inhibitor PLB1004 in Non-Small Cell Lung Cancer
Official Title
A Phase I Open-label, Multi-dose, Dose Escalation and Dose Expansion Study of the Oral EGFR Inhibitor PLB1004 in Non-Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 29, 2023 (Anticipated)
Primary Completion Date
February 9, 2028 (Anticipated)
Study Completion Date
February 9, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Avistone Biotechnology Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This is a Phase I, multicenter, open-label, dose escalation and dose expansion study to assess the safety and pharmacokinetic profile of PLB1004, a mono-anilino-pyrimidine compound, given alone in NSCLC patients with EGFR exon 20 insertion mutations. Patients will be enrolled and dosed according to the most current protocol. This study is made of two Parts. Part 1 includes a dose escalation into 7 cohorts and patient allocation to these cohorts will be via slot allocation. Each cohort has a minimum of 3 and a maximum of 6 patients for a total of 21 - 42 patients. Part 2 includes an expansion phase and patient allocation to two dose levels with 20 patients per cohort.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
82 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PLB1004
Arm Type
Experimental
Arm Description
PLB1004 given as a mono-therapy in dose escalation and dose expansion phase.
Intervention Type
Drug
Intervention Name(s)
PLB1004
Intervention Description
PLB1004 will be orally self-administered by the patient as a mono-therapy.
Primary Outcome Measure Information:
Title
Safety profile of PLB1004 per CTCAE v5.0
Time Frame
Up to 2 years
Secondary Outcome Measure Information:
Title
To define the DLTs and MTD
Time Frame
Up to 3 years
Title
Area Under the Curve (AUC) of PLB1004
Time Frame
Approximately 28 days.
Title
Maximum plasma concentration (Cmax) of PLB1004
Time Frame
Approximately 28 days.
Title
Time to maximum plasma concentration (Tmax) of PLB1004
Time Frame
Approximately 28 days.
Title
Overall Response Rate (ORR)
Time Frame
Up to 3 years
Title
Progression-Free Survival (PFS)
Time Frame
Up to 3 years
Title
Overall Survival (OS)
Time Frame
Up to 3 years
Title
Disease Control Rate (DCR)
Time Frame
Up to 3 years
Title
Duration of Response (DOR)
Time Frame
Up to 3 years
Title
Change from baseline in corrected QT interval (QTc) using Fridericia formula (QTcF)
Time Frame
Up to 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ability to understand and willingness to sign a written informed consent document; Male or female adult patients 18 years of age or older; Patients should have recovered from toxicities related to prior anti-tumor therapy; Patients should have recovered from the effects of major surgery; Have a documented EGFR in-frame exon 20 insertion mutation by a local test in tissue or plasma; At least 12 weeks life expectancy; Must have at least one measurable lesion per RECIST v 1.1; Sexually active males and females of childbearing potential must agree to take effective contraceptive measures. Exclusion Criteria: Received radiotherapy within 14 days before enrollment; Have significant or uncontrolled systemic disease; Have significant or uncontrolled cardiovascular disease; Have had other diagnosed malignant diseases that required treatment within the past 3 years besides NSCLC; Currently have or had a history of interstitial lung disease, drug-induced interstitial lung disease, or radiation pneumonia that requires steroid therapy; Have known hypersensitivity to the similar drugs and excipients of PLB1004; Pregnant or lactating women; Have used other experimental drugs within 2 weeks prior to the first dose of PLB1004; Have any condition or illness that could affect the compliance with the protocol.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weizhe Xue, Ph.D
Phone
+86-10-84148931
Email
xueweizhe@avistonebio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weizhe Xue, Ph.D
Organizational Affiliation
Avistone Biotechnology Co., Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Nebraska Cancer Specialists
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ralph J. Hauke, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Study of the Oral EGFR Inhibitor PLB1004 in Non-Small Cell Lung Cancer

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