Non-Small Cell Lung CancerPhase 1NCT03130881
Phase I Study of a Selective ALK Inhibitor PLB1003 in Patients With ALK+ NSCLC.
A Phase 1 study testing PLB1003 in people with Non-Small Cell Lung Cancer, run by Beijing Pearl Biotechnology Limited Liability Company at 1 site in China.
Trial summary
This phase I, first-in-human dose-escalation study was conducted to determine the maximum tolerated dose (MTD), recommended phase II dose (RP2D), dose-limiting toxicities (DLTs), pharmacokinetics (PK) profile, and preliminary antitumor activity of PLB1003. 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?
- PLB1003
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 8 Nov 2016to 30 Dec 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Signed Informed Consent Form
- Age≥18 years
- Diagnosed with a locally advanced or metastatic non-small cell lung cancer that has progressed despite standard therapy.
- Must have evidence of ALK positivity from the results of molecular pre-screening evaluations
- At least one measurable lesion as per RECIST v1.1
- Patients must have recovered from all toxicities related to prior anticancer therapies to grade ≤ 1
- ECOG Performance Status of 0-2
Who cannot join
- Symptomatic central nervous system (CNS) metastases that are neurologically unstable or requiring increasing doses of steroids to control, and patients with any CNS deficits.
- Clinically significant, uncontrolled heart diseases. Unstable angina. History of documented congestive heart failure (New York Heart Association functional classification III-IV) .
- Active peptic ulcer disease or gastritis
- Major surgery within 4 weeks prior to starting PLB1003
- Previous anti-cancer and investigational agents within 4 weeks before first dose of PLB1003..
- Pregnant or nursing women
- Involved in other clinical trials < 30 days prior to Day 1
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030
Baohui Han, MD, +86-21-22200000, xkyyhan@gmail.com
Tianqing Chu, MD, +86-21-22200000, ctqxkyy@163.com
About this study
Official title: A Phase I Open-label, Multicenter Dose Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics (PK) of PLB1003 in Patients With ALK-positive (ALK+) Advanced Non-small Cell Lung Cancer (NSCLC)
This phase I, first-in-human dose-escalation study was conducted to determine the maximum tolerated dose (MTD), recommended phase II dose (RP2D), dose-limiting toxicities (DLTs), pharmacokinetics (PK) profile, and preliminary antitumor activity of PLB1003.
Read the detailed description
This is a Phase I, open-label study of PB1003 administered orally to patients with ALK-positive (ALK+) advanced NSCLC. The study includes a Dose-escalation Part (part A) and a Dose Expansion Part (part B). The aim of the part A is to estimate the MTD and to identify the dose limited toxicity(DLT) and the recommended phase II dose (RP2D) for PLB1003 single agent as well as to determine the PK/PD profile. Once response has been observed in certain dose level, then followed by the expansion part to further assess the clinical efficacy and safety of PLB1003 single agent. Aprox 40 patients will be enrolled in PART A, while 12-24 patients for expansion cohort .
PLB1003 is a potent selective ALK inhibitor. PLB1003 acts on cancer by blocking abnormal ALK-mediated signaling, leading to profound tumour growth inhibition in xenografts of non-small cell lung cancer (NSCLC) tumours.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- PLB1003
- 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.
PLB1003Drug
PLB1003 is a capsule and is administered orally.
| Study group | Role | What they receive |
|---|---|---|
| PLB1003 | Experimental | ALK-positive (ALK+) advanced NSCLC Receives: Drug: PLB1003 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Dose Limiting Toxicities (DLTs) .
The maximum tolerated dose (MTD) was defined as the highest dose for a given schedule that was expected to cause DLTs in no more than 33% of patients during the first cycle of treatment.
Measured: 18 months.
Secondary outcomes (4)
Area under the plasma concentration versus time curve (AUC) of PLB1003 and its metabolite.
In the study of PK Run-in period, full Pharmacokinetics (PK) profiles of PLB1003 will be obtained following administration of a single oral dose of PLB1003 on Day 1 to Day 2. At multiple-dose, Pharmacokinetics (PK) sampling will include a pre-dose and at the 0.5, 2, 3,4, 6, 9, 10, 12 and 24 hour time points on days 1, 22 of dosing in the first 21-Day cycle of Treatment period, and pre-dose on days 16, 17 and 18 of the first 21-Day cycle of Treatment period.
Measured: Day 1-3 PK Run-in period and Day 1-21 Treatment period
Maximum plasma concentration observed (Cmax) of PLB1003 and its metabolite.
In the study of PK Run-in period, full Pharmacokinetics (PK) profiles of PLB1003 will be obtained following administration of a single oral dose of PLB-1003 on Day 1 to Day 2. At multiple-dose, Pharmacokinetics (PK) sampling will include a pre-dose and at the 0.5, 2, 3,4, 6, 9, 10, 12 and 24 hour time points on days 1, 22 of dosing in the first 21-Day cycle of Treatment period, and pre-dose on days 16, 17 and 18 of the first 21-Day cycle of Treatment period.
Measured: Day 1-3 PK Run-in period and Day 1-21 Treatment period
Time to Cmax (Tmax) of PLB1003 and its metabolite.
In the study of PK Run-in period, full Pharmacokinetics (PK) profiles of PLB1003 will be obtained following administration of a single oral dose of PLB-1003 on Day 1 to Day 2. At multiple-dose, Pharmacokinetics (PK) sampling will include a pre-dose and at the 0.5, 2, 3,4, 6, 9, 10, 12 and 24 hour time points on days 1, 22 of dosing in the first 21-Day cycle of Treatment period, and pre-dose on days 16, 17 and 18 of the first 21-Day cycle of Treatment period.
Measured: Day 1-3 PK Run-in period and Day 1-21 Treatment period
Preliminary antitumor activity of PLB1003.
Preliminary antitumor activity of PLB1003 assessed using RECIST1.1.
Measured: 30 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2017
- Study start8 Nov 2016
- Primary completion30 Dec 2020 (estimated)
- Study completion30 Dec 2021 (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.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Pearl Biotechnology Limited Liability Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Baohui Han, MD, Principal investigator, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03130881
- Sponsor's protocol ID
- HMO-PLB1003-20160828
- Status last verified
- Apr 2017
- First submitted
- 19 Apr 2017
- Last updated
- 4 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Open-label, Multicenter Dose Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics (PK) of PLB1003 in Patients With ALK-positive (ALK+) Advanced Non-small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT03130881
- Acronym / sponsor ID
- HMO-PLB1003-20160828
- Conditions
- Non-Small Cell Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Beijing Pearl Biotechnology Limited Liability CompanyIndustry (pharma, biotech, devices)
- Study start
- 8 Nov 2016 (actual)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 27 Apr 2017 (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 phase I, first-in-human dose-escalation study was conducted to determine the maximum tolerated dose (MTD), recommended phase II dose (RP2D), dose-limiting toxicities (DLTs), pharmacokinetics (PK) profile, and preliminary antitumor activity of PLB1003.
Detailed description
This is a Phase I, open-label study of PB1003 administered orally to patients with ALK-positive (ALK+) advanced NSCLC. The study includes a Dose-escalation Part (part A) and a Dose Expansion Part (part B). The aim of the part A is to estimate the MTD and to identify the dose limited toxicity(DLT) and the recommended phase II dose (RP2D) for PLB1003 single agent as well as to determine the PK/PD profile. Once response has been observed in certain dose level, then followed by the expansion part to further assess the clinical efficacy and safety of PLB1003 single agent. Aprox 40 patients will be enrolled in PART A, while 12-24 patients for expansion cohort .
PLB1003 is a potent selective ALK inhibitor. PLB1003 acts on cancer by blocking abnormal ALK-mediated signaling, leading to profound tumour growth inhibition in xenografts of non-small cell lung cancer (NSCLC) tumours.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PLB1003 | Experimental | Drug: PLB1003ALK-positive (ALK+) advanced NSCLC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed Informed Consent Form
- Age≥18 years
- Diagnosed with a locally advanced or metastatic non-small cell lung cancer that has progressed despite standard therapy.
- Must have evidence of ALK positivity from the results of molecular pre-screening evaluations
- At least one measurable lesion as per RECIST v1.1
Key exclusion criteria (7 listed)
- Symptomatic central nervous system (CNS) metastases that are neurologically unstable or requiring increasing doses of steroids to control, and patients with any CNS deficits.
- Clinically significant, uncontrolled heart diseases. Unstable angina. History of documented congestive heart failure (New York Heart Association functional classification III-IV) .
- Active peptic ulcer disease or gastritis
- Major surgery within 4 weeks prior to starting PLB1003
- Previous anti-cancer and investigational agents within 4 weeks before first dose of PLB1003..
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 |
|---|---|---|
| PLB1003PLB1003 is a capsule and is administered orally. | Drug | PLB1003 |
Primary outcome
Number of Participants With Dose Limiting Toxicities (DLTs) .
Time frame: 18 months.
The maximum tolerated dose (MTD) was defined as the highest dose for a given schedule that was expected to cause DLTs in no more than 33% of patients during the first cycle of treatment.
4 secondary outcomes
Area under the plasma concentration versus time curve (AUC) of PLB1003 and its metabolite.
Time frame: Day 1-3 PK Run-in period and Day 1-21 Treatment period
Maximum plasma concentration observed (Cmax) of PLB1003 and its metabolite.
Time frame: Day 1-3 PK Run-in period and Day 1-21 Treatment period
Time to Cmax (Tmax) of PLB1003 and its metabolite.
Time frame: Day 1-3 PK Run-in period and Day 1-21 Treatment period
Preliminary antitumor activity of PLB1003.
Time frame: 30 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Baohui Han, MD principal investigator
Shanghai Chest Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PLB1003 in people with Non-Small Cell Lung Cancer, run by Beijing Pearl Biotechnology Limited Liability Company at 1 site in China.
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 7 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 4 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peilong Zhang, Ph.D (+86-10-64392756, zhangpeilong@pearlbio.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Dose Limiting Toxicities (DLTs) . (time frame: 18 months.). 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 4 Mar 2020; AzTrials last refreshed its copy on 6 Nov 2026.