Non-Small Cell Lung CancerPhase 1NCT06046495
A Study of the Oral EGFR Inhibitor PLB1004 in Non-Small Cell Lung Cancer
A Phase 1 study testing PLB1004 in people with Non-Small Cell Lung Cancer, run by Avistone Biotechnology Co., Ltd. at 7 sites in United States.
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，uncommon mutations, classical mutations (Ex19del and L858R), and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- PLB1004
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 7 sitesUnited States
- Study dates
- 8 Jul 2024to 9 Feb 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Avistone Clinical Study Information Center Center contact
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Research Site
Louisville, Kentucky, 40202
- Recruiting
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Study Director, MD
- Recruiting
Research Site
New York, New York, 100021
- Recruiting
Nebraska Cancer Specialists
Omaha, Nebraska, 68130
Study Director, MD
- Recruiting
University of California-Davis
Sacramento, California, 95817-1514
Study Director, MD
- Recruiting
Swedish Health Sciences
Seattle, Washington, 98122
Study Director, MD
- Recruiting
Research Site
Seattle, Washington, 98195
About this study
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
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，uncommon mutations, classical mutations (Ex19del and L858R), and drug-resistant mutation (T790M). 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, or uncommon 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, classical mutations, or uncommon mutations.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- PLB1004
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PLB1004Drug
PLB1004 will be orally self-administered by the patient as a mono-therapy.
| Study group | Role | What they receive |
|---|---|---|
| PLB1004 | Experimental | PLB1004 given as a mono-therapy in dose escalation and dose expansion phase. Receives: Drug: PLB1004 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety profile of PLB1004 per CTCAE v5.0
Measured: Up to 2 years
Secondary outcomes (10)
To define the DLTs and MTD
Measured: Up to 3 years
Area Under the Curve (AUC) of PLB1004
Measured: Approximately 28 days.
Maximum plasma concentration (Cmax) of PLB1004
Measured: Approximately 28 days.
Time to maximum plasma concentration (Tmax) of PLB1004
Measured: Approximately 28 days.
Overall Response Rate (ORR)
Measured: Up to 3 years
Progression-Free Survival (PFS)
Measured: Up to 3 years
Overall Survival (OS)
Measured: Up to 3 years
Disease Control Rate (DCR)
Measured: Up to 3 years
Duration of Response (DOR)
Measured: Up to 3 years
Change from baseline in corrected QT interval (QTc) using Fridericia formula (QTcF)
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start8 Jul 2024
- Primary completion9 Feb 2028 (estimated)
- Study completion9 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Avistone Biotechnology Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 81 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Avistone Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06046495
- Sponsor's protocol ID
- PLB1004-I-US01
- Status last verified
- Apr 2025
- First submitted
- 6 Sep 2023
- Last updated
- 23 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06046495
- Acronym / sponsor ID
- PLB1004-I-US01
- Conditions
- Non-Small Cell Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- Avistone Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Jul 2024 (actual)
- Primary completion
- 9 Feb 2028 (estimated)
- Study completion
- 9 Feb 2028 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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，uncommon mutations, classical mutations (Ex19del and L858R), and drug-resistant mutation (T790M). 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, or uncommon 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, classical mutations, or uncommon mutations.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PLB1004 | Experimental | Drug: PLB1004PLB1004 given as a mono-therapy in dose escalation and dose expansion phase. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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 mutation by a local test in tissue or plasma;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PLB1004PLB1004 will be orally self-administered by the patient as a mono-therapy. | Drug | PLB1004 |
Primary outcome
Safety profile of PLB1004 per CTCAE v5.0
Time frame: Up to 2 years
10 secondary outcomes
To define the DLTs and MTD
Time frame: Up to 3 years
Area Under the Curve (AUC) of PLB1004
Time frame: Approximately 28 days.
Maximum plasma concentration (Cmax) of PLB1004
Time frame: Approximately 28 days.
Time to maximum plasma concentration (Tmax) of PLB1004
Time frame: Approximately 28 days.
Overall Response Rate (ORR)
Time frame: Up to 3 years
Progression-Free Survival (PFS)
Time frame: Up to 3 years
Overall Survival (OS)
Time frame: Up to 3 years
Disease Control Rate (DCR)
Time frame: Up to 3 years
Duration of Response (DOR)
Time frame: Up to 3 years
Change from baseline in corrected QT interval (QTc) using Fridericia formula (QTcF)
Time frame: Up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Avistone Clinical Study Information Center Center contact
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PLB1004 in people with Non-Small Cell Lung Cancer, run by Avistone Biotechnology Co., Ltd. at 7 sites in United States.
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 8 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 23 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Avistone Clinical Study Information Center Center (+86-10-84148921, information.center@avistonebio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety profile of PLB1004 per CTCAE v5.0 (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Apr 2025.