Status:
NOT_YET_RECRUITING
BPI-361175 Tablets in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
Lead Sponsor:
Xcovery Holdings, Inc.
Conditions:
Non-small Cell Lung Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is a three-stage study, consisting of Phase Ia dose-escalation, Phase Ib dose expansion, and a Phase II component.
Detailed Description
This is a Phase I/II, open-label, non-randomized study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of BPI-361175 tablets in patients with advanced NSCLC with EGFR C...
Eligibility Criteria
Inclusion
- Male or female ≥ 18 years old;
- Life expectancy ≥ 12 weeks;
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
- Patients with histologically or cytologically confirmed diagnosis of inoperable locally advanced or recurrent/metastatic NSCLC with EGFR mutations. Patients must have progressed from or be intolerant to or be unfit for standard treatment.
- For dose escalation: patients with documented EGFR mutation that have progressed on or after third-generation EGFR-TKI. In addition, other lines of therapy may have been given.
- For dose expansion and Phase II: patients with EGFR C797S mutation confirmed prior to enrollment on tissue or blood samples with radiological documentation of disease progression from first-generation, second-generation or third-generation EGFR-TKIs. In addition, other lines of therapy may have been given;
- For dose expansion and Phase II, patients must have at least one measurable tumor lesion per RECIST v1.1 criteria as per Investigator's assessment;
- Adequate bone marrow, liver, and renal function:
- Blood: Absolute neutrophil count (ANC) ≥ 1.5 × 109/L (1500/mm3), platelets count ≥ 100 × 109/L, hemoglobin ≥ 9 g/dL (90 g/L) (must not have received transfusion or granulocyte colony-stimulating factor within 2 weeks of screening tests and procedures);
- Liver function: total bilirubin ≤ 1.5 × ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 × ULN; if liver metastases exist, AST and ALT ≤ 5.0 × ULN; for patients with documented Gilbert's syndrome, total bilirubin ≤ 3.0 × ULN;
- Renal function: Estimated glomerular filtration rate (eGFR) ≥ 50 mL/min (calculated by CKD-EPI);
- All acute toxic effects of any prior antitumor therapy or surgery must have resolved to baseline or ≤ CTCAE Grade 1 (with the exception of alopecia);
- For women with childbearing potential, serum pregnancy test will be performed within 7 days before dosing, with a negative result, and they must be non-lactating; all patients should take medically recognized contraceptive measures throughout the treatment period and 3 months after the last dose (see section Error! Reference source not found.);
- Men with partners of childbearing potential willing to use adequate contraceptive measures during the study and for 90 days after the last dose of study medication.
- Patients must have fully understood and voluntarily signed informed consent form (ICF).
Exclusion
- Presence of another active primary malignant tumors;
- Unstable, symptomatic primary CNS tumors/metastasis or leptomeningeal metastases which are not suitable for enrollment, as judged by investigators. A patient can be enrolled if his/her clinical condition is stable and imaging evidence does not show disease progression within 2 weeks prior to the first dose, and who is off corticosteroid, anticonvulsant or mannitol treatment for longer than 2 weeks prior to the first dose.
- Treatment with the most recent therapy (e.g., chemotherapy, immunotherapy, targeted therapy, radiation therapy, investigational therapy/agent) within 4 weeks or approximately 5 half-lives, whichever is the longer, before the first dose. (If sufficient wash-out time has not occurred due to schedule or PK properties, an alternative appropriate wash-out time based on known duration and time to reversibility of drug related adverse events could be agreed upon by the sponsor and investigators);
- Gastrointestinal disorders that would affect oral swallowing or the investigators judge the absorption of the study drug will be interfered;
- Use of strong or moderate CYP3A inhibitors or inducers within 7 days prior to the first dose;
- Autologous (within 3 months) or allogeneic (within 6 months) organ or stem cell transplantation prior to the first dose; any major surgery or severe trauma (except biopsy sampling) within 4 months prior to the first dose;
- Palliative radiation therapy within 2 weeks prior to the first dose;
- Patients who have active viral hepatitis B (HBV) infection (exception: HBV DNA ≤ 500 IU/mL and has been stable for longer than 4 weeks);
- Patients who have active infections that required systemic therapy within 1 week prior to the first dose;
- Any of the following cardiac conditions within the last 6 months:
- Unexplained or cardiovascular cause of presyncope or syncope, tachycardia, ventricular fibrillation, or sudden cardiac arrest. Prolonged corrected QT interval \[mean resting corrected QT interval QTcF \> 450 msec for males or \> 470 msec for females from 3 electrocardiogram (ECG)\];
- Any \> CTCAE Grade 1 prior to the first dose;
- 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, any uncontrolled systemic disease, and other serious illnesses;
- Patients with deep venous thrombosis, pulmonary embolism or any other serious thromboembolism within 3 months prior to the first dose (implantable venous access-port, catheter-related thrombosis or superficial venous thrombosis is not considered as "serious" thromboembolism);
- The presence of drug abuse and medical, psychological, or social conditions that do not permit compliance with the protocol or will not be available for protocol-required study visits or procedures.
Key Trial Info
Start Date :
July 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2029
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05393466
Start Date
July 1 2026
End Date
May 31 2029
Last Update
October 7 2025
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