Metastasis, NeoplasmPhase 1NCT05302843
A Phase 1 Study of BPI-28592 in Subjects With Advanced Solid Tumors
A Phase 1 study testing BPI-28592 in people with Metastasis, Neoplasm, run by Betta Pharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
This is an open-labe Phase I study of BPI-28592 for the treatment of patients with solid tumors Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastasis, Neoplasm
- What is being tested?
- BPI-28592
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 22 Mar 2021to 31 Dec 2023
- Phase
- Phase 1
- 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
- Histologically- or cytologically-confirmed diagnosis of locally advanced or metastatic solid tumor
- At least 18 years of age
- Measurable or evaluable disease
- Adequate organ function as defined per protocol
Who cannot join
- Symptomatic or unstable brain metastases
- Pregnancy or lactation
- Other protocol specified criteria
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sir Run Run Shaw Hospital (SRRSH), affiliated with the Zhejiang University School of Medicine
Hangzhou, Zhejiang
Hongming Pan, Ph.D
About this study
Official title: A Phase 1，Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Ascendind Doses of BPI-28592 in Subjects With Advanced Solid Tumors
This is an open-labe Phase I study of BPI-28592 for the treatment of patients with solid tumors
- Conditions
- Metastasis, Neoplasm
- Being tested
- BPI-28592
- Keywords
- NTRK1/2/3, fusion
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BPI-28592Drug
Characterize the pharmacokinetics (PK)，safety，antitumor activity of BPI-28592
| Study group | Role | What they receive |
|---|---|---|
| dose exploration and dose expansion | Experimental | Patients receive BPI-28592 PO. Cycles repeat every 28 days. Receives: Drug: BPI-28592 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterize the safety and tolerability of BPI-28592 in subjects with advanced solid tumor malignancies
Number of subjects with treatment related adverse events
Measured: about 20 months
determine the recommended Phase II dose (RP2D) and preliminarily to develop a suitable dosing regimen
Number of subjects with dose limiting toxicity
Measured: about 20 months
Secondary outcomes (6)
Evaluate the pharmacokinetics of BPI-28592
Blood plasma concentration
Measured: about 20 months
To determine overall response rate (ORR),calculated as the proportion of subjects with confirmed complete (CR) or partial response (PR) to BPI-28592
Evaluate clinical activity/efficacy of BPI-28592
Measured: about 20 months
To evaluate the duration of response (DOR) in subjects with CR or PR as best response
Evaluate clinical activity/efficacy of BPI-28592
Measured: about 20 months
to evaluate the disease control rate (DCR)
Evaluate clinical activity/efficacy of BPI-28592
Measured: about 20 months
To evaluate progression-free survival (PFS) following initiation of BPI-28592
Evaluate clinical activity/efficacy of BPI-28592
Measured: about 20 months
To evaluate overall (OS) following initiation of BPI-28592
Evaluate clinical activity/efficacy of BPI-28592
Measured: about 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start22 Mar 2021
- Primary completion31 Dec 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastasis, NeoplasmStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Betta Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05302843
- Sponsor's protocol ID
- BTP-661211
- Status last verified
- Mar 2022
- First submitted
- 10 Mar 2022
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sheng J, Chen H, Fu B, Pan H, Wang J, Han W. BPI-28592 as a novel second generation inhibitor for NTRK fusion tumors. NPJ Precis Oncol. 2024 Sep 11;8(1):198. doi: 10.1038/s41698-024-00686-8.
PubMed 39256512
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1，Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Ascendind Doses of BPI-28592 in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05302843
- Acronym / sponsor ID
- BTP-661211
- Conditions
- Metastasis, Neoplasm
- Keywords
- NTRK1/2/3, fusion
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Betta Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Mar 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 31 Mar 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 an open-labe Phase I study of BPI-28592 for the treatment of patients with solid tumors
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dose exploration and dose expansion | Experimental | Drug: BPI-28592Patients receive BPI-28592 PO. Cycles repeat every 28 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically- or cytologically-confirmed diagnosis of locally advanced or metastatic solid tumor
- At least 18 years of age
- Measurable or evaluable disease
- Adequate organ function as defined per protocol
Key exclusion criteria (3 listed)
- Symptomatic or unstable brain metastases
- 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-28592Characterize the pharmacokinetics (PK)，safety，antitumor activity of BPI-28592 | Drug | dose exploration and dose expansion |
Primary outcome
Characterize the safety and tolerability of BPI-28592 in subjects with advanced solid tumor malignancies
Time frame: about 20 months
Number of subjects with treatment related adverse events
determine the recommended Phase II dose (RP2D) and preliminarily to develop a suitable dosing regimen
Time frame: about 20 months
Number of subjects with dose limiting toxicity
6 secondary outcomes
Evaluate the pharmacokinetics of BPI-28592
Time frame: about 20 months
To determine overall response rate (ORR),calculated as the proportion of subjects with confirmed complete (CR) or partial response (PR) to BPI-28592
Time frame: about 20 months
To evaluate the duration of response (DOR) in subjects with CR or PR as best response
Time frame: about 20 months
to evaluate the disease control rate (DCR)
Time frame: about 20 months
To evaluate progression-free survival (PFS) following initiation of BPI-28592
Time frame: about 20 months
To evaluate overall (OS) following initiation of BPI-28592
Time frame: about 20 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Derived from this study: PubMed 39256512Sheng J, Chen H, Fu B, Pan H, Wang J, Han W. BPI-28592 as a novel second generation inhibitor for NTRK fusion tumors. NPJ Precis Oncol. 2024 Sep 11;8(1):198. doi: 10.1038/s41698-024-00686-8.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BPI-28592 in people with Metastasis, Neoplasm, run by Betta Pharmaceuticals Co., Ltd. at 1 site 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 4 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 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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.
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 Hongming Pan, Ph.D (0571-86006922, shonco@sina.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterize the safety and tolerability of BPI-28592 in subjects with advanced solid tumor malignancies (time frame: about 20 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?
On the ClinicalTrials.gov record for NCT05302843, which also lists 1 linked publication.
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 31 Mar 2022.