Non-small Cell Lung CancerPhase 1/2NCT05329298
A Phase 1/2 Study of BPI-361175 in Subjects With Advanced Solid Tumors
A Phase 1/2 study testing BPI-361175 in people with Non-small Cell Lung Cancer, run by Betta Pharmaceuticals Co., Ltd. at 8 sites in China.
Trial summary
This is a phase I/II, open-label study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of BPI-361175 tablets in patients with advanced solid tumors including advanced Non-small cell Lung cancer (NSCLC).This is a three-stage study, consisting of Phase Ia dose escalation, Phase Ib dose… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- BPI-361175
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 8 sitesChina
- Study dates
- 21 Jul 2021to 31 Dec 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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;
- Patients with histologically or cytologically confirmed diagnosis of inoperable locally advanced or recurrent/metastatic non-small cell lung cancer (NSCLC) with EGFR sensitive mutations. Patients must have progressed from or be intolerant to or be unfit for standard treatment, or the standard treatment does not exist;
- For dose expansion and Phase II, patients must be willing to provide tumor tissues (archived tumor tissue samples within 2 years or fresh tumor tissues) and/or blood samples for central lab testing;
- Measurable or evaluable disease;
- Adequate bone marrow, liver, and renal function.
Who cannot join
- Unstable, symptomatic primary CNS tumors/metastasis or leptomeningeal metastases which are not suitable for enrollment, as judged by investigators;
- Pregnancy or lactation;
- Other protocol specified criteria.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites, 8 recruiting
- Recruiting
Xiangya Hospital of Central South University
Changsha, Hunan, 410011
Chengping Hu, Ph.D, 0731-89753733, 664990095@qq.com
- Recruiting
Hunan cancer hospital
Changsha, Hunan, 410013
Nong Yang, Ph.D
- Recruiting
the First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310003
Jianying Zhou, Ph.D, 0571-87236114, drzjy@163.com
- Recruiting
Jiangsu Cancer Hospital
Nanjing, Jiangsu, 210009
Meiqi Shi, Ph.D, 0731-88651322, yangnongpi@163.com
- Recruiting
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029
Yongqian Shu, Ph.D, 025-83714511
- Recruiting
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433
Caicun Zhou, Ph.D, 021-65115006, fkzlkzhoudr@126.com
Caicun Zhou, Ph.D
- Recruiting
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Qian Chu, Ph.D, qianchu@163.com
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450008
Qiming Wang, Ph.D
About this study
Official title: A Phase 1/2 Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of BPI-361175 in Subjects With Advanced Solid Tumors
This is a phase I/II, open-label study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of BPI-361175 tablets in patients with advanced solid tumors including advanced Non-small cell Lung cancer (NSCLC).This is a three-stage study, consisting of Phase Ia dose escalation, Phase Ib dose expansion and pivotal Phase II Study. The pivotal Phase II study will be designed based on data generated from the Phase I studies.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- BPI-361175
- 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
Subjects will receive BPI-361175 until disease progression
| Study group | Role | What they receive |
|---|---|---|
| Phase I | Experimental | Patients will receive a single dose on Day 1, then after an 7-day wash-out period, repeated dosing, once daily will be initiated(Ia).
Patients receive BPI-361175 PO. Cycles repeat every 28 days(Ib). Receives: Drug: BPI-361175 |
| Phase II | Experimental | Patients receive BPI-361175 based on RP2D. Receives: Drug: BPI-361175 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: The adverse events (AEs)
Safety and tolerability will be assessed by monitoring frequency, duration and severity of adverse events (AEs).
Measured: Through the Phase I, approximately 24 months
Phase I: Determine the recommended Phase II dose (RP2D)
Number of subjects with dose limiting toxicity
Measured: Through the Phase I, approximately 24 months
Phase II: the objective response rate (ORR)
The proportion of patients with complete response (CR) and partial response (PR) in all patients.
Measured: Through the Phase II, approximately 24 months
Secondary outcomes (10)
Phase I: Evaluate the pharmacokinetics of BPI-361175
Blood plasma concentration
Measured: Through the Phase I, approximately 24 months
Phase I: the objective response rate (ORR)
The proportion of patients with complete response (CR) and partial response (PR) in all patients.
Measured: Through the Phase I, approximately 24 months
Phase II: Disease control rate (DCR)
The proportion of patients with CR, PR and stable disease (SD) in all patients.
Measured: Through the Phase II, approximately 24 months
Phase II: Progression free survival (PFS)
The time from the first study dose to disease progression (PD) or death, whichever occurs first.
Measured: Through the Phase II, approximately 24 months
Phase II: Overall survival (OS)
The time from the first study dose to death due to any cause.
Measured: Through the Phase II, approximately 24 months
Phase II: Duration of response (DOR)
The time from the first CR or PR to the first PD or death due to any cause.
Measured: Through the Phase II, approximately 24 months
Phase II: The adverse events (AEs)
Safety and tolerability will be assessed by monitoring frequency, duration and severity of adverse events (AEs).
Measured: Through the Phase II, approximately 24 months
Phase I: Disease control rate (DCR)
The proportion of patients with CR, PR and stable disease (SD) in all patients.
Measured: Through the Phase I, approximately 24 months
Phase I: Progression free survival (PFS)
The time from the first study dose to disease progression (PD) or death, whichever occurs first.
Measured: Through the Phase I, approximately 24 months
Phase I: Overall survival (OS)
The time from the first study dose to death due to any cause.
Measured: Through the Phase I, approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start21 Jul 2021
- Primary completion30 Jun 2023 (estimated)
- Study completion31 Dec 2023 (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 CancerStudies of the same condition, open and under way.
- More trials run by Betta Pharmaceuticals Co., Ltd.The sponsor's other registered studies.
- 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
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Betta Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Caicun Zhou, Ph.D, Principal investigator, Shanghai Pulmonary Hospital, Shanghai, ChinaJianying Zhou, Ph.D, Principal investigator, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05329298
- Sponsor's protocol ID
- BTP-661411
- Status last verified
- Mar 2022
- First submitted
- 31 Mar 2022
- Last updated
- 15 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of BPI-361175 in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05329298
- Acronym / sponsor ID
- BTP-661411
- Conditions
- Non-small Cell Lung Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Betta Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Jul 2021 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 15 Apr 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 phase I/II, open-label study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of BPI-361175 tablets in patients with advanced solid tumors including advanced Non-small cell Lung cancer (NSCLC).This is a three-stage study, consisting of Phase Ia dose escalation, Phase Ib dose expansion and pivotal Phase II Study. The pivotal Phase II study will be designed based on data generated from the Phase I studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase I | Experimental | Drug: BPI-361175Patients will receive a single dose on Day 1, then after an 7-day wash-out period, repeated dosing, once daily will be initiated(Ia). Patients receive BPI-361175 PO. Cycles repeat every 28 days(Ib). |
| Phase II | Experimental | Drug: BPI-361175Patients receive BPI-361175 based on RP2D. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female ≥ 18 years old;
- Patients with histologically or cytologically confirmed diagnosis of inoperable locally advanced or recurrent/metastatic non-small cell lung cancer (NSCLC) with EGFR sensitive mutations. Patients must have progressed from or be intolerant to or be unfit for standard treatment, or the standard treatment does not exist;
- For dose expansion and Phase II, patients must be willing to provide tumor tissues (archived tumor tissue samples within 2 years or fresh tumor tissues) and/or blood samples for central lab testing;
- Measurable or evaluable disease;
- Adequate bone marrow, liver, and renal function.
Key exclusion criteria (3 listed)
- Unstable, symptomatic primary CNS tumors/metastasis or leptomeningeal metastases which are not suitable for enrollment, as judged by investigators;
- Pregnancy or lactation;
- Other protocol specified criteria.
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-361175Subjects will receive BPI-361175 until disease progression | Drug | Phase I, Phase II |
Primary outcome
Phase I: The adverse events (AEs)
Time frame: Through the Phase I, approximately 24 months
Safety and tolerability will be assessed by monitoring frequency, duration and severity of adverse events (AEs).
Phase I: Determine the recommended Phase II dose (RP2D)
Time frame: Through the Phase I, approximately 24 months
Number of subjects with dose limiting toxicity
Phase II: the objective response rate (ORR)
Time frame: Through the Phase II, approximately 24 months
The proportion of patients with complete response (CR) and partial response (PR) in all patients.
10 secondary outcomes
Phase I: Evaluate the pharmacokinetics of BPI-361175
Time frame: Through the Phase I, approximately 24 months
Phase I: the objective response rate (ORR)
Time frame: Through the Phase I, approximately 24 months
Phase II: Disease control rate (DCR)
Time frame: Through the Phase II, approximately 24 months
Phase II: Progression free survival (PFS)
Time frame: Through the Phase II, approximately 24 months
Phase II: Overall survival (OS)
Time frame: Through the Phase II, approximately 24 months
Phase II: Duration of response (DOR)
Time frame: Through the Phase II, approximately 24 months
Phase II: The adverse events (AEs)
Time frame: Through the Phase II, approximately 24 months
Phase I: Disease control rate (DCR)
Time frame: Through the Phase I, approximately 24 months
Phase I: Progression free survival (PFS)
Time frame: Through the Phase I, approximately 24 months
Phase I: Overall survival (OS)
Time frame: Through the Phase I, approximately 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2022.
- 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. This study is not recruiting at the moment.
Caicun Zhou, Ph.D principal investigator
Shanghai Pulmonary Hospital, Shanghai, China
Jianying Zhou, Ph.D principal investigator
First Affiliated Hospital of Zhejiang University
8 sites in 1 country: see every site and its status.
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 Cancer, run by Betta Pharmaceuticals Co., Ltd. at 8 sites in China.
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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 15 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Caicun Zhou, Ph.D (021-65115006, fkzlkzhoudr@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase I: The adverse events (AEs) (time frame: Through the Phase I, approximately 24 months). The study lists 3 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 15 Apr 2022.