A Study With BPI-1178 and Osimertinib in Advanced Non-small Cell Lung Cancer Patients With EGFR Mutations

Sponsor
National Cancer Center, China
Study ID
NCT06362980
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • BPI-1178 — DRUG
    200 or 300 mg, oral, QD
  • Osimertinib — DRUG
    80mg, oral, QD

Study Details

BPI-1178 is a novel, orally administered inhibitor of both cyclin-dependent kinase 4 (CDK4) and CDK6 kinase activity. This open-label investigator-initiated trial (IIT) phase I study was designed to evaluate the safety and efficacy of oral BPI-1178 in combination with osimertinib in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) and epidermal growth factor receptor (EGFR) Mutations.

Key Dates

Start date
May 22, 2024
Status verified
Jul 2024
Primary completion
Apr 1, 2025
Completion
Apr 1, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: BPI-1178 plus Osimertinib treatment
    Patients will undergo treatment with a combination of BPI-1178 capsules and osimertinib tablets. Patients will orally receive a single dose of BPI-1178 (200 or 300 mg) capsules and osimertinib tablets (80 mg). After a 7-day washout period, continuous dosing will commence on the 8th day. During the continuous dosing phase, BPI-1178 capsules and osimertinib tablets will be administered once daily, with a treatment cycle consisting of 28 days.

Primary Outcome Measure

Number of patients with dose-limiting toxicity (DLT) [ Time Frame: From first dosing (Day 7) to Day 28 of Cycle 1 (28 days/cycle) ]

Central Contacts

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