Solid TumorPhase 1NCT05369312
Phase 1 Study of BPI-442096 in Advanced Solid Tumor Patients
A Phase 1 study testing BPI-442096 in people with Solid Tumor and Non-small Cell Lung Cancer, run by Betta Pharmaceuticals Co., Ltd. at 5 sites in China.
Trial summary
A first-in-human study to evaluate the safety, tolerability and maximum tolerated dose (MTD) and establish the recommended phase 2 dose (RP2D) of BPI-442096, a SHP2 inhibitor, in patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumor, Non-small Cell Lung Cancer, Pancreatic Cancer
- What is being tested?
- BPI-442096
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 5 sitesChina
- Study dates
- Jun 2022to 1 May 2025
- 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
- Signed informed consent;
- Age ≥18 and ≤75 years, male and female patients;
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1;
- Dose escalation phase: histologically or cytologically confirmed locally advanced or metastatic solid tumor patients (excluding HCC 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 non-small cell lung cancer, pancreatic cancer, colorectal cancer or other diagnosed solid tumor patients (excluding HCC patients), 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 required for dose expansion phase;
- Dose expansion only: Patients must have confirmation of tumour mutation status (including KRAS G12, Class-3 BRAF, NF1 LOF mutations, RTK mutations, amplifications or rearrangements).
- Adequate organ function;
Who cannot join
- Patients who have previously received a SHP2 inhibitor;
- Inadequate wash-out of prior therapies described per protocol, which may include anti-tumor therapies, tumor adjuvant drugs, organ or stem cell transplantation, moderate or strong CYP3A inhibitor or inducer;
- Patients with severe or unstable systemic disease, unstable/symptomatic CNS metastasis, other malignant tumors, autoimmune disease, ILD, 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
5 sites in 1 country.
5 sites in 1 country
China5 sites
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080
Yilong Wu, Ph.D, 020-83525210, syylwu@live.cn
The First Affiliated Hospital of Sun yat-sen university
Guangzhou, Guangdong, 510080
Yubiao Guo, Ph.D, 020-87608185, guoyubiao@hotmail.com
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310004
Xinmin Yu, Ph.D, 0571-88122168, yuxm@zjcc.org.cn
Zhongshan Hospital affiliated to Fudan University
Xuhui, Shanghai Municipality, 200032
Tianshu Liu, Ph.D, 021-31587861, liu.tianshu@zs-hospital.sh.cn
Henan Tumor Hospital
Zhengzhou, Henan, 453100
Huijuan Wang, Ph.D, 0371-65587418, 18638561588@163.com
About this study
A first-in-human study to evaluate the safety, tolerability and maximum tolerated dose (MTD) and establish the recommended phase 2 dose (RP2D) of BPI-442096, a SHP2 inhibitor, in patients with advanced solid tumors.
Read the detailed description
The first-in-human (FIH) study of BPI-442096 will be an open-label, non-randomized, Phase 1 study utilizing a modified "3+3" dose escalation followed by an expansion phase in patients with KRAS G12 mutation, class-3 BRAF mutation, NF1 LOF mutation or RTK mutation, amplification or rearrangement advanced solid tumors. The primary objective is to determine safety and tolerability of BPI-442096, the MTD and RP2D. The secondary objectives are to assess the pharmacokinetic (PK) and pharmacodynamic (PD) profile, preliminary anti-tumor activity of BPI-442096.
- Being tested
- BPI-442096
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Pancreatic Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BPI-442096Drug
Subjects will receive BPI-442096 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-442096 administered, once daily (QD). Receives: Drug: BPI-442096 |
| Dose Expansion | Experimental | Oral tablets administered at MTD/RP2D defined dose. Each treatment cycle will be 21 days in duration with BPI-442096 administered, once daily (QD) Receives: Drug: BPI-442096 |
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
Determine the recommended Phase II dose (RP2D)
Number of subjects with dose limiting toxicity
Measured: Through the Phase I, approximately 24 months
Secondary outcomes (8)
Cmax
Maximum observed concentration
Measured: Through the Phase I, approximately 24 months
Tmax
Time to reach maximum observed plasma concentration
Measured: Through the Phase I, approximately 24 months
t1/2
Half-life time
Measured: Through the Phase I, approximately 24 months
AUC0-t
Area under the concentration-time curve from time 0 to t
Measured: Through the Phase I, approximately 24 months
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
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
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 I, approximately 24 months
Progression free survival (PFS)
The time from the date of randomization to disease progression (PD) or death, whichever occurs first
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 posted11 May 2022
- Study startJun 2022 (estimated)
- Primary completion1 May 2024 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Betta Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yilong Wu, Ph.D, Principal investigator, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05369312
- Sponsor's protocol ID
- BTP-661711
- Status last verified
- Apr 2022
- First submitted
- 5 May 2022
- Last updated
- 21 Jun 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 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of BPI-442096 in Advanced Solid Tumor Patients
- ClinicalTrials.gov ID
- NCT05369312
- Acronym / sponsor ID
- BTP-661711
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Betta Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2022 (estimated)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 11 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.
A first-in-human study to evaluate the safety, tolerability and maximum tolerated dose (MTD) and establish the recommended phase 2 dose (RP2D) of BPI-442096, a SHP2 inhibitor, in patients with advanced solid tumors.
Detailed description
The first-in-human (FIH) study of BPI-442096 will be an open-label, non-randomized, Phase 1 study utilizing a modified "3+3" dose escalation followed by an expansion phase in patients with KRAS G12 mutation, class-3 BRAF mutation, NF1 LOF mutation or RTK mutation, amplification or rearrangement advanced solid tumors. The primary objective is to determine safety and tolerability of BPI-442096, the MTD and RP2D. The secondary objectives are to assess the pharmacokinetic (PK) and pharmacodynamic (PD) profile, preliminary anti-tumor activity of BPI-442096.
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-442096Oral tablets taken in escalating levels to determine MTD/RP2D. Each treatment cycle will be 21 days in duration with BPI-442096 administered, once daily (QD). |
| Dose Expansion | Experimental | Drug: BPI-442096Oral tablets administered at MTD/RP2D defined dose. Each treatment cycle will be 21 days in duration with BPI-442096 administered, once daily (QD) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Signed informed consent;
- Age ≥18 and ≤75 years, male and female patients;
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1;
- Dose escalation phase: histologically or cytologically confirmed locally advanced or metastatic solid tumor patients (excluding HCC 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 non-small cell lung cancer, pancreatic cancer, colorectal cancer or other diagnosed solid tumor patients (excluding HCC 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 SHP2 inhibitor;
- Inadequate wash-out of prior therapies described per protocol, which may include anti-tumor therapies, tumor adjuvant drugs, organ or stem cell transplantation, moderate or strong CYP3A inhibitor or inducer;
- Patients with severe or unstable systemic disease, unstable/symptomatic CNS metastasis, other malignant tumors, autoimmune disease, ILD, 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-442096Subjects will receive BPI-442096 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).
Determine the recommended Phase II dose (RP2D)
Time frame: Through the Phase I, approximately 24 months
Number of subjects with dose limiting toxicity
8 secondary outcomes
Cmax
Time frame: Through the Phase I, approximately 24 months
Tmax
Time frame: Through the Phase I, approximately 24 months
t1/2
Time frame: Through the Phase I, approximately 24 months
AUC0-t
Time frame: Through the Phase I, approximately 24 months
the objective response rate (ORR）
Time frame: Through the Phase I, approximately 24 months
Disease control rate (DCR）
Time frame: Through the Phase I, approximately 24 months
Duration of response (DOR）
Time frame: Through the Phase I, approximately 24 months
Progression free survival (PFS)
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 21 Jun 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.
Yilong Wu, Ph.D principal investigator
Guangdong Provincial People's Hospital
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-442096 in people with Solid Tumor and Non-small Cell Lung 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 8 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: status not confirmed, as of the sponsor's last update on 21 Jun 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 Yilong Wu, Ph.D (020-83525210, syylwu@live.cn), 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 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 21 Jun 2022.