Solid TumorPhase 1NCT05843305
A Study of BPI-452080 in Subjects With Solid Tumors
A Phase 1 study testing BPI-452080 in people with Solid Tumor and Renal Cell Carcinoma, run by Betta Pharmaceuticals Co., Ltd. at 5 sites in China.
Trial summary
This open-label Phase 1 study will evaluate the efficacy and safety of BPI-452080 in patients with Solid Tumors Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Renal Cell Carcinoma, Von Hippel-Lindau Disease
- What is being tested?
- BPI-452080
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 5 sitesChina
- Study dates
- 28 Apr 2023to 31 Oct 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Arm1：has locally advanced or metastatic ccRCC and has progressed during treatment with at least one prior therapeutic regimen Arm2：Von Hippel-Lindau Disease-Associated Clear Cell Renal Cell Carcinoma Arm3：Other solid tumors
- Adequate organ function
- Evaluable lesion required for dose escalation phase and at least 1 measurable lesion required for dose expansion phase
Who cannot join
- Has received prior treatment with another HIF-2α 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, etc
- Patients with major surgery within 4 weeks, severe or unstable systemic disease, unstable/symptomatic CNS metastasis, other malignant tumors, ILD, clinical significant cardiac disease, bleeding or embolic disease, active infectious disease, or other medical or psychiatric condition that might interfere with participation in the trial or interfere with the interpretation of trial results, in the opinion of the investigator or medical monitor
- Pregnancy or lactation
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
West China Hospital of Sichuan University
Chengdu, 610041
Zhenhua Liu
Zhejiang Cancer Hospital
Hangzhou, 310000
Meiyu Fang
Hunan Cancer Hospital
Hunan, 410031
Shusuan Jiang
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 201321
Dingwei Ye, Ph.D, 13701663571, fuscc2012@163.com
Jian Zhang, Ph.D, 13918273761, Syner2000@163.com
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, 430000
Xiaoping Zhang
About this study
Official title: A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of BPI-452080 in Subjects With Solid Tumors
This open-label Phase 1 study will evaluate the efficacy and safety of BPI-452080 in patients with Solid Tumors
- Conditions
- Solid Tumor, Renal Cell Carcinoma, Von Hippel-Lindau Disease
- Being tested
- BPI-452080
- Medical subject headings
- Carcinoma, Renal Cell, von Hippel-Lindau Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BPI-452080Drug
Subjects will receive BPI-452080 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-452080 administered once daily. Receives: Drug: BPI-452080 |
| Dose Expansion | Experimental | Oral tablets administered at MTD/RP2D defined dose. Each treatment cycle will be 21 days in duration with BPI-452080 administered once daily.
Cohort 1: Locally Advanced or Metastatic ccRCC Cohort 2: VHL disease associated RCC Cohort 3: Other Advanced Solid Tumors Receives: Drug: BPI-452080 |
What is being measured
The primary outcome is the main question the study is designed to answer.
adverse events (AEs)
Safety and tolerability will be assessed by monitoring frequency, duration and severity of adverse events
Measured: Through the Phase I, approximately 24 months
Secondary outcomes (5)
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
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
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 posted6 May 2023
- Study start28 Apr 2023 (estimated)
- Primary completion25 Mar 2025 (estimated)
- Study completion31 Oct 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.
- 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
- 87 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Betta Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dingwei Ye, Ph.D, Principal investigator, Fudan UniversityJian Zhang, Ph.D, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05843305
- Sponsor's protocol ID
- BTP-661811
- Status last verified
- Apr 2023
- First submitted
- 12 Apr 2023
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of BPI-452080 in Subjects With Solid Tumors
- ClinicalTrials.gov ID
- NCT05843305
- Acronym / sponsor ID
- BTP-661811
- Conditions
- Solid Tumor, Renal Cell Carcinoma, Von Hippel-Lindau Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 87 participants (estimated)
- Lead sponsor
- Betta Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Apr 2023 (estimated)
- Primary completion
- 25 Mar 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 6 May 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 open-label Phase 1 study will evaluate the efficacy and safety of BPI-452080 in patients with Solid Tumors
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-452080Oral tablets taken in escalating levels to determine MTD/RP2D. Each treatment cycle will be 21 days in duration with BPI-452080 administered once daily. |
| Dose Expansion | Experimental | Drug: BPI-452080Oral tablets administered at MTD/RP2D defined dose. Each treatment cycle will be 21 days in duration with BPI-452080 administered once daily. Cohort 1: Locally Advanced or Metastatic ccRCC Cohort 2: VHL disease associated RCC Cohort 3: Other Advanced Solid Tumors |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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:
- Arm1：has locally advanced or metastatic ccRCC and has progressed during treatment with at least one prior therapeutic regimen Arm2：Von Hippel-Lindau Disease-Associated Clear Cell Renal Cell Carcinoma Arm3：Other solid tumors
- Adequate organ function
- Evaluable lesion required for dose escalation phase and at least 1 measurable lesion required for dose expansion phase
Key exclusion criteria (4 listed)
- Has received prior treatment with another HIF-2α 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, etc
- Patients with major surgery within 4 weeks, severe or unstable systemic disease, unstable/symptomatic CNS metastasis, other malignant tumors, ILD, clinical significant cardiac disease, bleeding or embolic disease, active infectious disease, or other medical or psychiatric condition that might interfere with participation in the trial or interfere with the interpretation of trial results, in the opinion of the investigator or medical monitor
- Pregnancy or lactation
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-452080Subjects will receive BPI-452080 until disease progression | Drug | Dose Escalation, Dose Expansion |
Primary outcome
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
5 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
the objective response rate（ORR）
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 6 May 2023.
Related trials for Solid Tumor
RecruitingPhase 1
A Study of DS-1103a Combination Therapy in Participants With Advanced Solid Tumors
Advanced Solid Tumor
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Recruiting
Virtual Reality Intervention to Improve Psychological Symptom Burden for Cancer Patients Undergoing Treatment
Adjustment Disorder, Anxiety Disorder
RecruitingPhase 1
Personalized KXV01 Lentinvivo (TCR) Injection as the Therapy for Advanced Solid Tumors
Advanced Solid Tumors
RecruitingObservational study
Obtaining Solid Tumor Tissue From People Having Biopsy or Surgery for Certain Types of Cancer
Colorectal Neoplasms, Gastric Neoplasms
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.
Dingwei Ye, Ph.D principal investigator
Fudan University
Jian Zhang, Ph.D principal investigator
Fudan University
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-452080 in people with Solid Tumor and Renal Cell Carcinoma, 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 5 inclusion and 4 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 6 May 2023. 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 Dingwei Ye, Ph.D (13701663571, fuscc2012@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adverse events (AEs) (time frame: Through the Phase I, approximately 24 months). 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 6 May 2023.