Malignant NeoplasmsPhase 1NCT05315180
A Phase 1，Open-label Study of BPI-421286 in Subjects With Advanced Solid Tumors
A Phase 1 study testing BPI-421286 in people with Malignant Neoplasms and Metastatic Cancer, run by Betta Pharmaceuticals Co., Ltd. at 5 sites in China.
Trial summary
Evaluate the safety and tolerability of BPI-421286 in adult subjects with advanced solid tumors. Estimate the maximum tolerated dose (MTD) and/or a recommended phase 2 dose (RP2D) in adult subjects with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Malignant Neoplasms, Metastatic Cancer
- What is being tested?
- BPI-421286
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 5 sitesChina
- Study dates
- 24 Aug 2021to 31 Jul 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically documented, locally-advanced or metastatic malignancy
- Standard treatment is not available or patient declines
- Adequate organ function
Who cannot join
- Active brain metastases from non-brain tumors.
- Gastrointestinal (GI) tract disease causing the inability to take oral medication.
- Other protocol specified criteria
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Wen Li, Ph.D
Hangzhou, Zhejiang, 310009
310009 Li, Ph.D, 13958194313, liwenzjhz0408@163.com
- Recruiting
Yun Fan,Ph.D
Hangzhou, Zhejiang, 310022
Yun Fan, Ph.D, 0571-88122092, fanyun@zjcc.org.cn
- Recruiting
Shun Lu, Ph.D
Shanghai, Shanghai Municipality, 200030
Shun Lu, Ph.D, 13601813062, shun_lu@hotmail.com
- Recruiting
Shun Lu, Ph.D
Shanghai, 200030
Shun Lu, Ph.D, 13601813062, shun_lu@hotmail.com
Shun Lu, Ph.D
- Recruiting
Dingzhi Huang, Ph.D
Tianjin, Tianjin Municipality
Dingzhi Huang, Ph.D, 18622221232, dingzhi72@163.com
About this study
Official title: A Phase 1，Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of BPI-421286 in Subjects With Advanced Solid Tumors
Evaluate the safety and tolerability of BPI-421286 in adult subjects with advanced solid tumors.
Estimate the maximum tolerated dose (MTD) and/or a recommended phase 2 dose (RP2D) in adult subjects with advanced solid tumors.
- Conditions
- Malignant Neoplasms, Metastatic Cancer
- Being tested
- BPI-421286
- Keywords
- Antineoplastic Agents, KRAS, NSCLC, Colorectal Cancer, Pancreatic Cancer, KRAS G12C
- Medical subject headings
- Neoplasms, Neoplasm Metastasis, Colorectal Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BPI-421286Drug
Characterize the pharmacokinetics (PK)，safety，effcicay of BPI-421286 following administration as an oral Tablet formulation
| Study group | Role | What they receive |
|---|---|---|
| dose exploration | Experimental | Enrollment into the dose exploration cohorts may be from any eligible solid tumor type. Dose escalation will begin with 1-6 subjects treated at the lowest planned dose level. If no DLT is observed, dose escalation will continue to the next planned dose cohort Receives: Drug: BPI-421286 |
| dose expansion | Experimental | dose expansion may proceed with 2 groups consisting of subjects with KRAS p.G12C mutant advanced solid tumors. Dose expansion in these 2 groups may be done concurrently Receives: Drug: BPI-421286 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterize the safety and tolerability of BPI-421286 in subjects with advanced solid tumor malignancies
Number of subjects with treatment related adverse events
Measured: 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: 20 months
Secondary outcomes (6)
Evaluate the pharmacokinetics of BPI-421286
Blood plasma concentration
Measured: 20 months
To determine overall response rate (ORR),calculated as the proportion of subjects with confirmed complete (CR) or partial response (PR) to BPI-421286
Evaluate clinical activity/efficacy of BPI-421286
Measured: 20 months
To evaluate the duration of response (DOR) in subjects with CR or PR as best response
Evaluate clinical activity/efficacy of BPI-421286
Measured: 20 months
to evaluate the disease control rate (DCR)
Evaluate clinical activity/efficacy of BPI-421286
Measured: 20 months
To evaluate progression-free survival (PFS) following initiation of BPI-421286
Evaluate clinical activity/efficacy of BPI-421286
Measured: 20 months
To evaluate overall (OS) following initiation of BPI-421286
Evaluate clinical activity/efficacy of BPI-421286
Measured: 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start24 Aug 2021
- Primary completion31 Jul 2023 (estimated)
- Study completion31 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant NeoplasmsStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 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
- NCT05315180
- Sponsor's protocol ID
- BTP-661311
- Status last verified
- Feb 2022
- First submitted
- 29 Mar 2022
- Last updated
- 7 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 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1，Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of BPI-421286 in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05315180
- Acronym / sponsor ID
- BTP-661311
- Conditions
- Malignant Neoplasms, Metastatic Cancer
- Keywords
- Antineoplastic Agents, KRAS, NSCLC, Colorectal Cancer, Pancreatic Cancer, KRAS G12C
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Betta Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Aug 2021 (actual)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 7 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.
Evaluate the safety and tolerability of BPI-421286 in adult subjects with advanced solid tumors.
Estimate the maximum tolerated dose (MTD) and/or a recommended phase 2 dose (RP2D) in adult subjects with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dose exploration | Experimental | Drug: BPI-421286Enrollment into the dose exploration cohorts may be from any eligible solid tumor type. Dose escalation will begin with 1-6 subjects treated at the lowest planned dose level. If no DLT is observed, dose escalation will continue to the next planned dose cohort |
| dose expansion | Experimental | Drug: BPI-421286dose expansion may proceed with 2 groups consisting of subjects with KRAS p.G12C mutant advanced solid tumors. Dose expansion in these 2 groups may be done concurrently |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Pathologically documented, locally-advanced or metastatic malignancy
- Standard treatment is not available or patient declines
- Adequate organ function
Key exclusion criteria (3 listed)
- Active brain metastases from non-brain tumors.
- Gastrointestinal (GI) tract disease causing the inability to take oral medication.
- 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-421286Characterize the pharmacokinetics (PK)，safety，effcicay of BPI-421286 following administration as an oral Tablet formulation | Drug | dose expansion, dose exploration |
Primary outcome
Characterize the safety and tolerability of BPI-421286 in subjects with advanced solid tumor malignancies
Time frame: 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: 20 months
Number of subjects with dose limiting toxicity
6 secondary outcomes
Evaluate the pharmacokinetics of BPI-421286
Time frame: 20 months
To determine overall response rate (ORR),calculated as the proportion of subjects with confirmed complete (CR) or partial response (PR) to BPI-421286
Time frame: 20 months
To evaluate the duration of response (DOR) in subjects with CR or PR as best response
Time frame: 20 months
to evaluate the disease control rate (DCR)
Time frame: 20 months
To evaluate progression-free survival (PFS) following initiation of BPI-421286
Time frame: 20 months
To evaluate overall (OS) following initiation of BPI-421286
Time frame: 20 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 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.
5 sites 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-421286 in people with Malignant Neoplasms and Metastatic Cancer, run by Betta Pharmaceuticals Co., Ltd. at 5 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 3 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 7 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 5 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 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 Shun Lu, Ph.D (13601813062, shun_lu@hotmail.com), 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-421286 in subjects with advanced solid tumor malignancies (time frame: 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?
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 Apr 2022.