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

Part of paid clinical trials in Sacramento, California.

Sponsor
Avistone Biotechnology Co., Ltd.
Study ID
NCT06046495
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jul 8, 2024
Status verified
Apr 2025
Primary completion
Feb 9, 2028
Completion
Feb 9, 2028

Study Design

Enrollment
81 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Safety profile of PLB1004 per CTCAE v5.0 [ Time Frame: Up to 2 years ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
University of California-DavisSacramentoCalifornia95817-1514
Study Director, MD
Research SiteLouisvilleKentucky40202-
Nebraska Cancer SpecialistsOmahaNebraska68130
Study Director, MD
Research SiteNew YorkNew York100021-
Sarah Cannon Research InstituteNashvilleTennessee37203
Study Director, MD
Research SiteSeattleWashington98195-
Swedish Health SciencesSeattleWashington98122
Study Director, MD

Find similar trials in Sacramento, CA

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
University of California-Davis· Sacramento, CAResearch Site· Louisville, KYNebraska Cancer Specialists· Omaha, NEResearch Site· New York, NYSarah Cannon Research Institute· Nashville, TNResearch Site· Seattle, WA

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