Status unknownNCT05347628Updated Aug 21, 2023

Assessing the Safety and Efficacy of PLB1004 in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

A Phase 1 interventional study of PLB1004 in Non-Small-Cell Lung Cancer, sponsored by Avistone Biotechnology Co., Ltd.. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-21.

Sponsored by Avistone Biotechnology Co., Ltd. · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2023), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

Registered 1 year 7 months after the study started (first participant enrolled Aug 2020, registered Apr 2022).

Phase: Phase 1
Study type: Interventional
Enrollment: 91
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study summary

This is a phase I, open-label, multicenter study to assess the safety, tolerability, pharmacokinetics and preliminary antitumor activity of PLB1004, and to determine the maximum tolerated dose (MTD), dose-limiting toxicities (DLTs) and recommended phase II dose (RP2D).

Read the detailed description

The study includes a Dose-escalation Part and a Dose Expansion Part. The aim of the Dose-escalation Part is to estimate the MTD (if possible), identify the DLT (if possible) and the RP2D for PLB1004. The Dose Expansion Part is to further assess the clinical efficacy and safety of PLB1004.

Conditions studied

Non-Small-Cell Lung Cancer

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Keywords

Non-Small-Cell Lung Cancer
EGFR
NSCLC
Lung Cancer

In context

Carcinoma, Non-Small-Cell Lung

6,641 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,665 are open to participants now.

This study's planned enrollment of 91 is above the median of 62 across 5,327 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Avistone Biotechnology Co., Ltd. is the lead sponsor of 12 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Ability to understand and the willingness to sign a written informed consent document；
Aged at least 18 years old;
Histologically or cytologically confirmed advanced non-small cell lung cancer;
Patients with EGFR or HER2 mutations;
ECOG Performance Status of 0-2;
Life expectancy is not less than 12 weeks;
At least one measurable lesion as defined by RECIST1.1;

Exclusion criteria

Exclusion Criteria:

For the Dose Expansion Part: Patients who have received prior treatment with Poziotinib or TAK788 or other EGFR/HER2 exon20 insertion inhibitors should be excluded；
Any cytotoxic drugs or other anticancer drugs from a previous treatment regimen within 14 days prior to the first dose of PLB1004；
Major surgery (e.g., intra-thoracic, intra-abdominal or intra-pelvic) within 4 weeks prior (2 weeks for resection of brain metastases) to starting PLB1004 or who have not recovered from side effects of such procedure;
Thoracic radiotherapy to lung fields ≤ 4 weeks prior to starting PLB1004. For all other anatomic sites (including radiotherapy to thoracic vertebrae and ribs), radiotherapy ≤ 2 weeks prior to starting PLB1004 or patients who have not recovered from radiotherapy-related toxicities. Palliative radiotherapy for bone lesions ≤ 2 weeks prior to starting PLB1004 is allowed;
Patients receiving treatment with medications that meet one of the following criteria and that cannot be discontinued at least 1 week prior to the start of treatment with PLB1004 and for the duration of the study:
- Strong inhibitors of CYP3A4
- Strong inducers of CYP3A4
- Inducers or inhibitors of P-gp
Patients with symptomatic central nervous system (CNS) metastases who are neurologically unstable or have required increasing doses of steroids within the 2 weeks prior to study entry to manage CNS symptoms;
Clinically significant, uncontrolled heart diseases;
Presence or history of a malignant disease other than NSCLC that has been diagnosed and/or required therapy within the past 3 years. Exceptions to this exclusion include the following: completely resected basal cell and squamous cell skin cancers, indolent malignancies that currently do not require treatment, and completely resectedcarcinoma in situ of any type;
Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease;
History of hypersensitivity to active or inactive excipients of PLB1004 or drugs with a similar chemical structure or class to PLB1004;
Pregnant or nursing women;
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;

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 91 participants (estimated)

Study arms

Experimental
PLB1004
PLB1004 given alone as monotherapy.
Drug: PLB1004

Interventions

DrugPLB1004
PLB1004 is a capsule in the form of 10mg and 40mg.

What researchers measure

Primary outcomes

Incidence of Treatment-Emergent Adverse Events (TEAEs)
A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
Time frame: 2 years
DLTs of Orally Administered PLB1004
Toxicity will be evaluated according to the NCI CTCAE, Version 5.00. DLT will be defined as any of the events specified in the protocol that are considered by the investigator to be at least possibly related to therapy with study medications.
Time frame: 28 days
Maximum Tolerated Dose (MTD) of Orally Administered PLB1004
The MTD is the highest dose level at which the participant tolerates treatment without dose-limiting toxicities.
Time frame: 28 days
Recommended Phase II Dose (RP2D) of Orally Administered PLB1004
The RP2D is the maximum tolerated dose (MTD) or less. An RP2D less than the MTD may be chosen if aspects of tolerability or efficacy not encompassed by the MTD determination suggest utilizing a lower dose.
Time frame: 2 years

Secondary outcomes

Area Under the Curve (AUC) of PLB1004
The AUC values are based on the plasma concentration-time profile of PLB1004. To characterize the pharmacokinetics of PLB1004.
Time frame: Up to approximately 28 days; Pre-dose and multiple time points post-dose
Maximum plasma concentration (Cmax) of PLB1004
The Cmax values are based on the plasma concentration-time profile of PLB1004. To characterize the pharmacokinetics of PLB1004.
Time frame: Up to approximately 28 days; Pre-dose and multiple time points post-dose
Time to maximum plasma concentration (Tmax) of PLB1004
The Tmax values are based on the plasma concentration-time profile of PLB1004. To characterize the pharmacokinetics of PLB1004.
Time frame: Up to approximately 28 days; Pre-dose and multiple time points post-dose
Overall Response Rate (ORR)
ORR is defined as the proportion of subjects with confirmed best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1.
Time frame: 3 years
Progression-Free Survival (PFS)
PFS is defined as the time interval from the date of starting treatment until the first date at which the criteria for progressive disease (PD) according to RECIST 1.1 are met or death, whichever occurs first.
Time frame: 3 years
Overall Survival (OS)
OS is defined as the time from date of starting treatment to date of death due to any cause.
Time frame: 3 years
Disease Control Rate (DCR)
DCR is defined as the percentage of participants who have achieved CR, PR, or SD after the initiation of study drug.
Time frame: 3 years
Duration of Response (DOR)
DOR is defined as the time from first documented response of CR or PR to date of first documented progression or death according to RECIST 1.1.
Time frame: 3 years

Study locations

1 site

Guangdong General Hospital
Guangzhou, Guangdong 510080, China

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05347628
Lead sponsor: Avistone Biotechnology Co., Ltd.
Responsible party: Sponsor
First posted: Apr 26, 2022
Start date: Aug 25, 2020
Primary completion: Apr 4, 2023
Completion: Nov 30, 2024 (estimated)
Last update: Aug 21, 2023

Study contacts

Yilong Wu, MD

principal investigator · Guangdong Provincial People's Hospital

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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