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

Non-Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06046495
• Other study ID #: PLB1004-I-US01
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: November 29, 2023
• Est. completion date: February 9, 2028

Study information

• Verified date: April 2024
• Source: Avistone Biotechnology Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. The patient population of the dose escalation phase will include patients with advanced NSCLC harboring EGFR classical mutations or Ex20ins mutations. Part 2 includes an expansion phase and the expansion phase will explore one or more dose levels of PLB1004 in NSCLC patients with EGFR Ex20ins mutations.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 82
• Est. completion date: February 9, 2028
• Est. primary completion date: February 9, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Ability to understand and willingness to sign a written informed consent document;

2. Male or female adult patients 18 years of age or older;

3. Patients should have recovered from toxicities related to prior anti-tumor therapy;

4. Patients should have recovered from the effects of major surgery;

5. Have a documented EGFR mutation by a local test in tissue or plasma;

1. Inclusion criteria specific for Dose Escalation:

Patients with a documented EGFR classical mutation or EGFR Ex20ins mutation, alone or in combination with other EGFR mutations;

2. Inclusion criteria specific for Dose Expansion:

Patients with a documented EGFR Ex20ins mutations (alone or in combination with other EGFR mutations);

6. At least 12 weeks life expectancy;

7. Must have at least one measurable lesion per RECIST v 1.1;

8. Sexually active males and females of childbearing potential must agree to take effective contraceptive measures.

Exclusion Criteria:

1. Received radiotherapy within 14 days before enrollment;

2. Have significant or uncontrolled systemic disease;

3. Have significant or uncontrolled cardiovascular disease;

4. Have had other diagnosed malignant diseases that required treatment within the past 3 years besides NSCLC;

5. Currently have or had a history of interstitial lung disease, drug-induced interstitial lung disease, or radiation pneumonia that requires steroid therapy;

6. Have known hypersensitivity to the similar drugs and excipients of PLB1004;

7. Pregnant or lactating women;

8. Have used other experimental drugs within 2 weeks prior to the first dose of PLB1004;

9. Have any condition or illness that could affect the compliance with the protocol.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Drug:
• PLB1004
PLB1004 will be orally self-administered by the patient as a mono-therapy.

Locations

Country	Name	City	State
United States	Sarah Cannon Research Institute	Nashville	Tennessee
United States	Nebraska Cancer Specialists	Omaha	Nebraska
United States	University of California-Davis	Sacramento	California
United States	Swedish Health Sciences	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Avistone Biotechnology Co., Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety profile of PLB1004 per CTCAE v5.0		Up to 2 years
Secondary	To define the DLTs and MTD		Up to 3 years
Secondary	Area Under the Curve (AUC) of PLB1004		Approximately 28 days.
Secondary	Maximum plasma concentration (Cmax) of PLB1004		Approximately 28 days.
Secondary	Time to maximum plasma concentration (Tmax) of PLB1004		Approximately 28 days.
Secondary	Overall Response Rate (ORR)		Up to 3 years
Secondary	Progression-Free Survival (PFS)		Up to 3 years
Secondary	Overall Survival (OS)		Up to 3 years
Secondary	Disease Control Rate (DCR)		Up to 3 years
Secondary	Duration of Response (DOR)		Up to 3 years
Secondary	Change from baseline in corrected QT interval (QTc) using Fridericia formula (QTcF)		Up to 3 years