Advanced Solid TumorPhase 1NCT05789602
A Study of BPI-460372 in Advanced Solid Tumor Patients
A Phase 1 study testing BPI-460372 in people with Advanced Solid Tumor, run by Betta Pharmaceuticals Co., Ltd. at 11 sites in China.
Trial summary
This study is an open-label, single arm, dose escalation and dose expansion phase 1 study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of BPI-460372 in solid tumor patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- BPI-460372
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 11 sitesChina
- Study dates
- 24 Apr 2023to 17 Apr 2026
- Phase
- Phase 1
- 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
- Signed informed consent;
- Age ≥18, male and female patients；
- Expected survival ≥ 3 months；
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1;
- Dose escalation phase: histologically or cytologically confirmed locally advanced or metastatic solid tumor patients, who had disease progression after standard therapy, intolerable to standard therapy, refuse to standard therapy or for whom no standard therapy exists;
- Dose expansion phase: histologically or cytologically confirmed locally advanced Malignant mesothelioma, Epithelioid hemangioendothelioma or other diagnosed solid tumor patients with NF2 defects, YAP/TAZ fusion, LATS1/2 mutations, and other Hippo signaling pathway abnormalities , who had disease progression after standard therapy, intolerable to standard therapy, refuse to standard therapy or for whom no standard therapy exists;
- Evaluable lesion required for dose escalation phase and at least 1 measurable lesion as per RECIST v1.1 or mRECIST v1.1 required for dose expansion phase;
Who cannot join
- Patients who have previously received a TEAD inhibitor;
- Inadequate wash-out of prior therapies described per protocol, which may include anti-tumor therapies, tumor adjuvant drugs, organ or stem cell transplantation，etc；
- Patients with severe or unstable systemic disease, unstable/symptomatic CNS metastasis, meningeal metastasis and spinal cord compression，malignant tumors, cardiac disease, bleeding or embolic disease, infectious disease, conditions affecting drug swallow and absorption, medical history leading to chronic diarrhea, etc;
- Pregnancy or lactation;
- Other conditions considered not appropriate to participate in this trial by the investigators.
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
China11 sites, 11 recruiting
- Recruiting
Affiliated Hospital of Hebei University
Baoding, Hebei, 050031
Aimin Zang
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100032
Mengzhao Wang, 010-69155039, mengzhaowang@sina.com
Xiaohong Han, 010-69156114, hanxiaohong@pumch.cn
- Not yet recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality
Yutao Liu
- Not yet recruiting
China-Japan Union Hospital of Jilin University
Changchun, Jilin, 130033
Linlin Liu
- Recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410031
Lin Wu
- Not yet recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
Yan Yu
- Recruiting
Central Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, 250013
Meili Sun
Qing Wen
- Not yet recruiting
Shandong Cancer Hospital
Jinan, Shandong, 250117
Ligang Xing
- Not yet recruiting
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, 317000
Dongqing Lv
- Not yet recruiting
Tongji Hospital Tongji Medical College of HUST
Wuhan, Hubei, 430030
Qian Chu
- Not yet recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Zhengzhou, 450052
Xingya Li
About this study
Official title: A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BPI-460372 in Advanced Solid Tumor Patients
This study is an open-label, single arm, dose escalation and dose expansion phase 1 study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of BPI-460372 in solid tumor patients.
- Conditions
- Advanced Solid Tumor
- Being tested
- BPI-460372
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BPI-460372Drug
Subjects will receive BPI-460372 until disease progression
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation | Experimental | Oral tablets taken in escalating levels to determine MTD/RP2D. Each treatment cycle will be 21 days in duration with BPI-460372 administered, once daily (QD). Receives: Drug: BPI-460372 |
| Dose Expansion | Experimental | Oral tablets administered at MTD/RP2D defined dose. Each treatment cycle will be 21 days in duration with BPI-460372 administered, once daily (QD) Receives: Drug: BPI-460372 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
The dose-limiting toxicity（DLT）
The dose-limiting toxicity
Measured: Through the Phase I, approximately 24 months
Determine the Maximum Tolerated Dose (MTD)
The MTD will be based on DLT.
Measured: Through the Phase I, approximately 24 months
Secondary outcomes (2)
Evaluate the pharmacokinetics of BPI-460372
Based on blood plasma concentration
Measured: Time Frame: Through the Phase I, approximately 24 months
Evaluate the effectiveness of BPI-460372
Efficacy assessments (tumor evaluation) will be performed per RECIST1.1 or mRECIST1.1
Measured: Time Frame: 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 posted29 Mar 2023
- Study start24 Apr 2023
- Primary completion17 Apr 2025 (estimated)
- Study completion17 Apr 2026 (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 Advanced Solid TumorStudies 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 82 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
- NCT05789602
- Sponsor's protocol ID
- BTP-661911
- Status last verified
- Jan 2025
- First submitted
- 16 Mar 2023
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liang H, Xu Y, Zhao J, Liu X, Zhong W, Zheng X, Liu H, Chen M, Han X, Wang M. First-in-human phase Ia study of the covalent TEAD palmitoylation inhibitor BPI-460372 in patients with advanced solid tumors: pharmacokinetics, exposure-limited dosing, and early antitumor activity. Biomark Res. 2026 Oct 9;14(1):138. doi: 10.1186/s40364-026-01012-z.
PubMed 42855739
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BPI-460372 in Advanced Solid Tumor Patients
- ClinicalTrials.gov ID
- NCT05789602
- Acronym / sponsor ID
- BTP-661911
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Betta Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Apr 2023 (actual)
- Primary completion
- 17 Apr 2025 (estimated)
- Study completion
- 17 Apr 2026 (estimated)
- First posted
- 29 Mar 2023 (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 study is an open-label, single arm, dose escalation and dose expansion phase 1 study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of BPI-460372 in solid tumor patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation | Experimental | Drug: BPI-460372Oral tablets taken in escalating levels to determine MTD/RP2D. Each treatment cycle will be 21 days in duration with BPI-460372 administered, once daily (QD). |
| Dose Expansion | Experimental | Drug: BPI-460372Oral tablets administered at MTD/RP2D defined dose. Each treatment cycle will be 21 days in duration with BPI-460372 administered, once daily (QD) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed informed consent;
- Age ≥18, male and female patients；
- Expected survival ≥ 3 months；
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1;
- Dose escalation phase: histologically or cytologically confirmed locally advanced or metastatic solid tumor patients, who had disease progression after standard therapy, intolerable to standard therapy, refuse to standard therapy or for whom no standard therapy exists;
Key exclusion criteria (5 listed)
- Patients who have previously received a TEAD inhibitor;
- Inadequate wash-out of prior therapies described per protocol, which may include anti-tumor therapies, tumor adjuvant drugs, organ or stem cell transplantation，etc；
- Patients with severe or unstable systemic disease, unstable/symptomatic CNS metastasis, meningeal metastasis and spinal cord compression，malignant tumors, cardiac disease, bleeding or embolic disease, infectious disease, conditions affecting drug swallow and absorption, medical history leading to chronic diarrhea, etc;
- Pregnancy or lactation;
- Other conditions considered not appropriate to participate in this trial by the investigators.
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-460372Subjects will receive BPI-460372 until disease progression | Drug | Dose Escalation, Dose Expansion |
Primary outcome
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).
The dose-limiting toxicity（DLT）
Time frame: Through the Phase I, approximately 24 months
The dose-limiting toxicity
Determine the Maximum Tolerated Dose (MTD)
Time frame: Through the Phase I, approximately 24 months
The MTD will be based on DLT.
2 secondary outcomes
Evaluate the pharmacokinetics of BPI-460372
Time frame: Time Frame: Through the Phase I, approximately 24 months
Evaluate the effectiveness of BPI-460372
Time frame: Time Frame: Through the Phase I, approximately 24 months
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 27 Jan 2025.
- Derived from this study: PubMed 42855739Liang H, Xu Y, Zhao J, Liu X, Zhong W, Zheng X, Liu H, Chen M, Han X, Wang M. First-in-human phase Ia study of the covalent TEAD palmitoylation inhibitor BPI-460372 in patients with advanced solid tumors: pharmacokinetics, exposure-limited dosing, and early antitumor activity. Biomark Res. 2026 Oct 9;14(1):138. doi: 10.1186/s40364-026-01012-z.
- 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.
11 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-460372 in people with Advanced Solid Tumor, run by Betta Pharmaceuticals Co., Ltd. at 11 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 7 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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?
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 Mengzhao Wang, Ph.D (010-69155039, mengzhaowang@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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?
On the ClinicalTrials.gov record for NCT05789602, 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 27 Jan 2025.