Non-small Cell Lung CarcinomaPhase 1/2NCT05393466
BPI-361175 Tablets in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
A Phase 1/2 study testing BPI-361175 in people with Non-small Cell Lung Carcinoma, run by Xcovery Holdings, Inc..
Trial summary
This is a three-stage study, consisting of Phase Ia dose-escalation, Phase Ib dose expansion, and a Phase II component. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Carcinoma
- What is being tested?
- BPI-361175
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 31 May 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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
- 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;
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- 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).
Who cannot join
- 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;
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase I/II, Open-label Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of BPI-361175 Tablets in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
This is a three-stage study, consisting of Phase Ia dose-escalation, Phase Ib dose expansion, and a Phase II component.
Read the 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 C797S mutation and other EGFR-related mutations. Adult patients (18 and above) will receive a single dose of BPI-361175 followed by a 7-day washout period with continuous oral dosing of BPI-361175 in 28 days cycle.
This is a three-stage study, consisting of Phase Ia dose-escalation, Phase Ib dose expansion, and pivotal Phase II study.
It is expected to provide a brand-new treatment for advanced NSCLC. The study design utilizes a Bayesian Optimal Interval (BOIN) method to guide the dose level assignment of BPI-361175 and estimate the MTD/RP2D based on cumulative information on DLTs in the Cycle 0 + Cycle 1 of treatment.
- Conditions
- Non-small Cell Lung Carcinoma
- Being tested
- BPI-361175
- Keywords
- non-small cell lung carcinoma
- 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.
BPI-361175Drug
BPI-361175 is an oral fourth-generation EGFR inhibitor. The activation of EGFR signaling pathways is associated with various biological events such as proliferation, migration, differentiation, and apoptosis.
| Study group | Role | What they receive |
|---|---|---|
| Phase Ia Dose Escalation | Experimental | The number of patients enrolled will be determined based on the maximum number required to establish the RP2D according to a Bayesian Optimal Interval (BOIN) method and will depend on the true DLT rate. Up to 24 patients will be enrolled for the dose-finding part. Receives: Drug: BPI-361175 |
| Phase Ib Expansion Study | Experimental | Based on clinical data obtained from Part 1a, up to 24 patients with advanced NSCLC harboring EGFR C797S mutation will be enrolled in this dose expansion part of the study. One or more dose levels may be investigated dependent on emerging data. The sample size will be determined based on practical considerations. Receives: Drug: BPI-361175 |
| Phase II Study | Experimental | The phase II part will be conducted using a Bayesian Optimal Phase 2 (BOP2) method with efficacy monitoring based on cumulative information on Objective Response Rate (ORR). The BOP2 method will consist of 2 interim looks occurring when the number of evaluable patients reaches the pre-specified values of 10 and 20 and a final analysis when a total of 30 patients are evaluable. Receives: Drug: BPI-361175 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of patients with adverse events and serious adverse events graded per National Cancer Institute Common Terminology Criteria for Adverse Events and dose limiting toxicities for BPI 361175
To characterize the pharmacokinetics (PK) of BPI-361175 tablets in advanced NSCLC
Measured: 18 months
Efficacy of BPI-361175
To determine the recommended Phase II dose (RP2D).
Measured: 18 months
Secondary outcomes (16)
Tmax
Time to maximum plasma concentration
Measured: Baseline, Cycle 1 Day1, Day 8, Day 15, Day 22, Day 28, and Day 1 of additional cycles
Tumor assessments
RECIST
Measured: At the end of every even cycle
Determine maximum tolerated dose in milligrams of BPI-361175
MTD
Measured: Baseline up to Completion of Cycle 1 (28 days)
Cmax
maximum plasma concentration
Measured: Baseline, Cycle 1 Day1, Day 8, Day 15, Day 22, Day 28, and Day 1 of additional cycles
AUC0-t
Area under the plasma concentration-time curve from zero to the time of the last measurable concentration, as calculated using the trapezoidal rule.
Measured: Baseline, Cycle 1 Day1, Day 8, Day 15, Day 22, Day 28, and Day 1 of additional cycles
AUC0-∞
Area under the plasma concentration-time curve from zero to infinity.
Measured: Baseline, Cycle 1 Day1, Day 8, Day 15, Day 22, Day 28, and Day 1 of additional cycles
AUCextrap%
Percentage of the extrapolated area to the entire AUC.
Measured: Baseline, Cycle 1 Day1, Day 8, Day 15, Day 22, Day 28, and Day 1 of additional cycles
λz
Terminal elimination rate constant, as obtained by log-linear regression of the terminal segment of the plasma concentration vs time curve.
Measured: Baseline, Cycle 1 Day1, Day 8, Day 15, Day 22, Day 28, and Day 1 of additional cycles
t1/2
Terminal half-life, as calculated based on formula t1/2 = Ln(2)/λz
Measured: Baseline, Cycle 1 Day1, Day 8, Day 15, Day 22, Day 28, and Day 1 of additional cycles
Vz/F
Apparent volume of distribution, Vz/F = CL/F/λz.
Measured: Baseline, Cycle 1 Day1, Day 8, Day 15, Day 22, Day 28, and Day 1 of additional cycles
CL/F
Apparent plasma clearance, CL/F = dose/AUC0-∞.
Measured: Baseline, Cycle 1 Day1, Day 8, Day 15, Day 22, Day 28, and Day 1 of additional cycles
Tmax, ss
Time to maximum plasma concentration at steady state.
Measured: Baseline, Cycle 1 Day1, Day 8, Day 15, Day 22, Day 28, and Day 1 of additional cycles
Cmax, ss
Maximum concentration at steady state.
Measured: Baseline, Cycle 1 Day1, Day 8, Day 15, Day 22, Day 28, and Day 1 of additional cycles
Ctrough, ss
Trough concentration at steady state.
Measured: Baseline, Cycle 1 Day1, Day 8, Day 15, Day 22, Day 28, and Day 1 of additional cycles
Cmin, ss
Minimum trough concentration at steady state.
Measured: Baseline, Cycle 1 Day1, Day 8, Day 15, Day 22, Day 28, and Day 1 of additional cycles
Area under the plasma concentration-time curve from zero to the end of the dosing interval.
AUCss
Measured: Baseline, Cycle 1 Day1, Day 8, Day 15, Day 22, Day 28, and Day 1 of additional cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start1 Jul 2026 (estimated)
- Primary completion30 Jan 2028 (estimated)
- Study completion31 May 2029 (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 CarcinomaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xcovery Holdings, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Giovanni C Selvaggi, MD, Study director, Xcovery Holdings, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05393466
- Sponsor's protocol ID
- XCV-BPI361175-ONC-101
- Status last verified
- Oct 2025
- First submitted
- 2 May 2022
- Last updated
- 7 Oct 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Open-label Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of BPI-361175 Tablets in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT05393466
- Acronym / sponsor ID
- XCV-BPI361175-ONC-101
- Conditions
- Non-small Cell Lung Carcinoma
- Keywords
- non-small cell lung carcinoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Xcovery Holdings, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 30 Jan 2028 (estimated)
- Study completion
- 31 May 2029 (estimated)
- First posted
- 26 May 2022 (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 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 C797S mutation and other EGFR-related mutations. Adult patients (18 and above) will receive a single dose of BPI-361175 followed by a 7-day washout period with continuous oral dosing of BPI-361175 in 28 days cycle.
This is a three-stage study, consisting of Phase Ia dose-escalation, Phase Ib dose expansion, and pivotal Phase II study.
It is expected to provide a brand-new treatment for advanced NSCLC. The study design utilizes a Bayesian Optimal Interval (BOIN) method to guide the dose level assignment of BPI-361175 and estimate the MTD/RP2D based on cumulative information on DLTs in the Cycle 0 + Cycle 1 of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase Ia Dose Escalation | Experimental | Drug: BPI-361175The number of patients enrolled will be determined based on the maximum number required to establish the RP2D according to a Bayesian Optimal Interval (BOIN) method and will depend on the true DLT rate. Up to 24 patients will be enrolled for the dose-finding part. |
| Phase Ib Expansion Study | Experimental | Drug: BPI-361175Based on clinical data obtained from Part 1a, up to 24 patients with advanced NSCLC harboring EGFR C797S mutation will be enrolled in this dose expansion part of the study. One or more dose levels may be investigated dependent on emerging data. The sample size will be determined based on practical considerations. |
| Phase II Study | Experimental | Drug: BPI-361175The phase II part will be conducted using a Bayesian Optimal Phase 2 (BOP2) method with efficacy monitoring based on cumulative information on Objective Response Rate (ORR). The BOP2 method will consist of 2 interim looks occurring when the number of evaluable patients reaches the pre-specified values of 10 and 20 and a final analysis when a total of 30 patients are evaluable. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (15 listed)
- 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;
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 |
|---|---|---|
| BPI-361175BPI-361175 is an oral fourth-generation EGFR inhibitor. The activation of EGFR signaling pathways is associated with various biological events such as proliferation, migration, differentiation, and apoptosis. | Drug | Phase II Study, Phase Ia Dose Escalation, Phase Ib Expansion Study |
Primary outcome
The percentage of patients with adverse events and serious adverse events graded per National Cancer Institute Common Terminology Criteria for Adverse Events and dose limiting toxicities for BPI 361175
Time frame: 18 months
To characterize the pharmacokinetics (PK) of BPI-361175 tablets in advanced NSCLC
Efficacy of BPI-361175
Time frame: 18 months
To determine the recommended Phase II dose (RP2D).
16 secondary outcomes
Tmax
Time frame: Baseline, Cycle 1 Day1, Day 8, Day 15, Day 22, Day 28, and Day 1 of additional cycles
Tumor assessments
Time frame: At the end of every even cycle
Determine maximum tolerated dose in milligrams of BPI-361175
Time frame: Baseline up to Completion of Cycle 1 (28 days)
Cmax
Time frame: Baseline, Cycle 1 Day1, Day 8, Day 15, Day 22, Day 28, and Day 1 of additional cycles
AUC0-t
Time frame: Baseline, Cycle 1 Day1, Day 8, Day 15, Day 22, Day 28, and Day 1 of additional cycles
AUC0-∞
Time frame: Baseline, Cycle 1 Day1, Day 8, Day 15, Day 22, Day 28, and Day 1 of additional cycles
AUCextrap%
Time frame: Baseline, Cycle 1 Day1, Day 8, Day 15, Day 22, Day 28, and Day 1 of additional cycles
λz
Time frame: Baseline, Cycle 1 Day1, Day 8, Day 15, Day 22, Day 28, and Day 1 of additional cycles
t1/2
Time frame: Baseline, Cycle 1 Day1, Day 8, Day 15, Day 22, Day 28, and Day 1 of additional cycles
Vz/F
Time frame: Baseline, Cycle 1 Day1, Day 8, Day 15, Day 22, Day 28, and Day 1 of additional cycles
CL/F
Time frame: Baseline, Cycle 1 Day1, Day 8, Day 15, Day 22, Day 28, and Day 1 of additional cycles
Tmax, ss
Time frame: Baseline, Cycle 1 Day1, Day 8, Day 15, Day 22, Day 28, and Day 1 of additional cycles
Cmax, ss
Time frame: Baseline, Cycle 1 Day1, Day 8, Day 15, Day 22, Day 28, and Day 1 of additional cycles
Ctrough, ss
Time frame: Baseline, Cycle 1 Day1, Day 8, Day 15, Day 22, Day 28, and Day 1 of additional cycles
Cmin, ss
Time frame: Baseline, Cycle 1 Day1, Day 8, Day 15, Day 22, Day 28, and Day 1 of additional cycles
Area under the plasma concentration-time curve from zero to the end of the dosing interval.
Time frame: Baseline, Cycle 1 Day1, Day 8, Day 15, Day 22, Day 28, and Day 1 of additional cycles
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2025.
- Individual participant dataSharing planned: No
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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.
Giovanni C Selvaggi, MD study director
Xcovery Holdings, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BPI-361175 in people with Non-small Cell Lung Carcinoma, run by Xcovery Holdings, Inc..
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 15 inclusion and 15 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: opening soon, as of the sponsor's last update on 7 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Esteban Sanchez (561-835-9356 ext. 217, esteban@xcovery.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of patients with adverse events and serious adverse events graded per National Cancer Institute Common Terminology Criteria for Adverse Events and dose limiting toxicities for BPI 361175 (time frame: 18 months). The study lists 2 primary outcomes in all. 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 7 Oct 2025.