Advanced Solid CancerPhase 1NCT03791112
A Phase I Study of BPI-16350 in Patients with Advanced Solid Tumor
A Phase 1 study testing BPI-16350 in people with Advanced Solid Cancer, run by Betta Pharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
This was an open-label Phase I study. The primary objective of the study was to assess safety, tolerability, efficacy, and pharmacokinetic characteristics of BPI-16350 in different dose groups. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Advanced Solid Cancer
- What is being tested?
- BPI-16350
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteChina
- Study dates
- 18 Jul 2019to Dec 2025
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological or cytological diagnosis of patients with advanced solid tumors, pateints couldn't be benefit from the existing standard treatment options, and patients were not suitable for surgical resection or radiation therapy for the purpose of cure;
- There were measurable lesions defined in RECIST v. 1.1. Tumor lesions that had previously received radiotherapy or other local treatment were considered as measurable lesions only when disease progression at the treatment site was clearly recorded after treatment;
- Age ≥ 18 and ≤ 70 years old;
- Expected survival ≥ 12 weeks;
- Eastern Cancer Cooperative Group (ECOG) performance status 0-1;
- Adequate bone marrow, hepatic, and renal function;
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- Patients of child bearing potential must agree to take contraception during the study and for 90 days after the last day of treatment;
- All acute toxicity of previous anti-tumor treatment or surgery is relieved to baseline severity or NCI CTCAE version 4.03 ≤ 1 (except for hair loss or other toxicity that the investigator believes has no safety risk to the patient);
- Voluntarily enroll and sign informed consent, follow the trial treatment plan and visit plan.
Who cannot join
- Received other anti-tumor treatments (including chemotherapy, radiotherapy, immunotherapy and experimental treatment) within 28 days (for myelosuppressive drugs or treatment) or within 14 days (for non-myelosuppressive drugs or treatment) before receiving the study drug;
- Previous treatments for other CDK4/6 inhibitors, such as Abemaciclib (VERZENIOTM, LY2835219), Palbociclib (IBRANCE®, PD0332991), Ribociclib (KISQALI®, LEE-011), Birosiclib (XZP-) 3287), SHR-6390, Trilaciclib and G1T-38, etc.;
- Any of the following cardiac criteria: unexplained or cardiovascular causes of threatened syncope or syncope, ventricular tachycardia, ventricular fibrillation or cardiac arrest. Corrected QT interval prolongation [A mean corrected QT interval (male QTcF > 450 msec or female QTcF > 470 msec) obtained from 3 electrocardiogram (ECG) examinations at rest. Various clinically significant cardiac rhythm, conduction, resting ECG morphological abnormalities, such as complete left bundle branch block, III degree block, II degree block, PR interval > 250 msec;
- Clinically active bacterial, fungal or viral infections (eg active hepatitis B (HBV), hepatitis C (HCV), human immunodeficiency virus (HIV) and syphilis positive, no other activities required at the time of enrollment Screening for sexual infections);
- Patients who had undergone autologous or allogeneic organ or stem cell transplantation; patients who had undergone major surgery or severe trauma within 4 weeks prior to the first dose;
- The patient received the following treatment within 7 days prior to entering the study: a known or potent CYP3A inhibitor or inducer, and a drug primarily metabolized by CYP2C19; or consumed grapefruit and grapefruit juice;
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- Patients who received anti-tumor treatment of Chinese herbal medicine within 1 week before the first dose;
- There were primary CNS（central nervous system）malignant tumors. Patients with CNS metastases who failed local treatment. For patients with asymptomatic brain metastases, or stable clinical symptoms and no need for steroids and other treatments for brain metastases ≥ 28 days can be enrolled;
- Have had other malignant tumors in the past 5 years, except for basal cell carcinoma and cervical carcinoma in situ after radical treatment;
- Occurrence of venous/venous thrombosis within 6 months prior to the first dose, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism;
- The prevalence of familial and/or acquired thrombophilia, such as the presence of genetic or acquired defects such as anticoagulant, coagulation factors, fibrinolytic proteins, or the presence of acquired risk factors with a high tendency to thromboembolism;
- Any condition that affected the patient's swallowing of the drug, as well as conditions that seriously affect the absorption or pharmacokinetic parameters of the test drug, including uncontrollable nausea and vomiting, chronic gastrointestinal disease, gastrointestinal resection or surgical history;
- It was known to be severely allergic to study drugs or any excipients;
- The existence of drugs of abuse and patients whose medical, psychological or social conditions may interfere with or participate in the evaluation of the results of the study;
- Any unstable systemic diseases (including active ≥CTCAE level 2 clinically serious infections, uncontrolled high blood pressure, unstable angina pectoris, congestive heart failure, severe liver and kidney or metabolic diseases, etc.);
- Any condition that was unstable or may jeopardize patient safety and its compliance with the study;
- Other conditions that the investigator believeed were not suitable for participation in this trial.
Trial locations and contacts
1 site in 1 country.
About this study
This was an open-label Phase I study. The primary objective of the study was to assess safety, tolerability, efficacy, and pharmacokinetic characteristics of BPI-16350 in different dose groups.
Read the detailed description
The study was divided into two sections: dose escalation section and expanded enrollment section.
In dose escalation section, BPI-16350 were administered orally once daily (QD) to patients with locally advanced or metastatic solid tumors in different dose levels.The study was designed to evaluate the safety, tolerability, and pharmacokinetics of single dose and multiple doses of BPI-16350.
In expanded enrollment section, based on the results of dose escalation section, BPI-16350 were administered orally to patients with locally advanced or metastatic solid tumors, to further evaluate the safety, tolerability, and pharmacokinetics of BPI-16350.
- Conditions
- Advanced Solid Cancer
- Being tested
- BPI-16350
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BPI-16350Drug
BPI-16350 capsules administered orally
| Study group | Role | What they receive |
|---|---|---|
| 50mg QD | Experimental | Participants received 50 mg BPI-16350 administered orally (PO), once daily (QD), in a fasted state on Days 1 to 28 of a 28-day cycle. Receives: Drug: BPI-16350 |
| 100mg QD | Experimental | Participants received 100 mg BPI-16350 administered orally (PO), once daily (QD), in a fasted state on Days 1 to 28 of a 28-day cycle. Receives: Drug: BPI-16350 |
| 200mg QD | Experimental | Participants received 200 mg BPI-16350 administered orally (PO), once daily (QD), in a fasted state on Days 1 to 28 of a 28-day cycle. Receives: Drug: BPI-16350 |
| 300mg QD | Experimental | Participants received 300 mg BPI-16350 administered orally (PO), once daily (QD), in a fasted state on Days 1 to 28 of a 28-day cycle. Receives: Drug: BPI-16350 |
| 400mg QD | Experimental | Participants received 400 mg BPI-16350 administered orally (PO), once daily (QD), in a fasted state on Days 1 to 28 of a 28-day cycle. Receives: Drug: BPI-16350 |
| 500mg QD | Experimental | Participants received 500 mg BPI-16350 administered orally (PO), once daily (QD), in a fasted state on Days 1 to 28 of a 28-day cycle. Receives: Drug: BPI-16350 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants with Adverse Events
The safety and tolerability variables include adverse events, physical examinations, vital signs , clinical laboratory evaluations including serum chemistry, hematology , and urinalysis, and electrocardiograms (ECGs) in triplicate,Incidence and nature of DLTs ( dose-limiting toxicity), To determine the MTD (maximum tolerated dose).
Measured: 24 months
Secondary outcomes (3)
Cmax
Day 1-7 for single dose, and day 1-28 for steady state
Measured: 1 month
Half-life time
Day 1-7 for single dose, and day 1-28 for steady state
Measured: 1 month
Tmax
Measured: Time to Cmax
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2019
- Study start18 Jul 2019
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid CancerStudies 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
- 54 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
- NCT03791112
- Sponsor's protocol ID
- BTP-66711
- Status last verified
- Jan 2025
- First submitted
- 29 Dec 2018
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 of BPI-16350 in Patients with Advanced Solid Tumor
- ClinicalTrials.gov ID
- NCT03791112
- Acronym / sponsor ID
- BTP-66711
- Conditions
- Advanced Solid Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Betta Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Jul 2019 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 2 Jan 2019 (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 was an open-label Phase I study. The primary objective of the study was to assess safety, tolerability, efficacy, and pharmacokinetic characteristics of BPI-16350 in different dose groups.
Detailed description
The study was divided into two sections: dose escalation section and expanded enrollment section.
In dose escalation section, BPI-16350 were administered orally once daily (QD) to patients with locally advanced or metastatic solid tumors in different dose levels.The study was designed to evaluate the safety, tolerability, and pharmacokinetics of single dose and multiple doses of BPI-16350.
In expanded enrollment section, based on the results of dose escalation section, BPI-16350 were administered orally to patients with locally advanced or metastatic solid tumors, to further evaluate the safety, tolerability, and pharmacokinetics of BPI-16350.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 50mg QD | Experimental | Drug: BPI-16350Participants received 50 mg BPI-16350 administered orally (PO), once daily (QD), in a fasted state on Days 1 to 28 of a 28-day cycle. |
| 100mg QD | Experimental | Drug: BPI-16350Participants received 100 mg BPI-16350 administered orally (PO), once daily (QD), in a fasted state on Days 1 to 28 of a 28-day cycle. |
| 200mg QD | Experimental | Drug: BPI-16350Participants received 200 mg BPI-16350 administered orally (PO), once daily (QD), in a fasted state on Days 1 to 28 of a 28-day cycle. |
| 300mg QD | Experimental | Drug: BPI-16350Participants received 300 mg BPI-16350 administered orally (PO), once daily (QD), in a fasted state on Days 1 to 28 of a 28-day cycle. |
| 400mg QD | Experimental | Drug: BPI-16350Participants received 400 mg BPI-16350 administered orally (PO), once daily (QD), in a fasted state on Days 1 to 28 of a 28-day cycle. |
| 500mg QD | Experimental | Drug: BPI-16350Participants received 500 mg BPI-16350 administered orally (PO), once daily (QD), in a fasted state on Days 1 to 28 of a 28-day cycle. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histological or cytological diagnosis of patients with advanced solid tumors, pateints couldn't be benefit from the existing standard treatment options, and patients were not suitable for surgical resection or radiation therapy for the purpose of cure;
- There were measurable lesions defined in RECIST v. 1.1. Tumor lesions that had previously received radiotherapy or other local treatment were considered as measurable lesions only when disease progression at the treatment site was clearly recorded after treatment;
- Age ≥ 18 and ≤ 70 years old;
- Expected survival ≥ 12 weeks;
- Eastern Cancer Cooperative Group (ECOG) performance status 0-1;
Key exclusion criteria (17 listed)
- Received other anti-tumor treatments (including chemotherapy, radiotherapy, immunotherapy and experimental treatment) within 28 days (for myelosuppressive drugs or treatment) or within 14 days (for non-myelosuppressive drugs or treatment) before receiving the study drug;
- Previous treatments for other CDK4/6 inhibitors, such as Abemaciclib (VERZENIOTM, LY2835219), Palbociclib (IBRANCE®, PD0332991), Ribociclib (KISQALI®, LEE-011), Birosiclib (XZP-) 3287), SHR-6390, Trilaciclib and G1T-38, etc.;
- Any of the following cardiac criteria: unexplained or cardiovascular causes of threatened syncope or syncope, ventricular tachycardia, ventricular fibrillation or cardiac arrest. Corrected QT interval prolongation [A mean corrected QT interval (male QTcF > 450 msec or female QTcF > 470 msec) obtained from 3 electrocardiogram (ECG) examinations at rest. Various clinically significant cardiac rhythm, conduction, resting ECG morphological abnormalities, such as complete left bundle branch block, III degree block, II degree block, PR interval > 250 msec;
- Clinically active bacterial, fungal or viral infections (eg active hepatitis B (HBV), hepatitis C (HCV), human immunodeficiency virus (HIV) and syphilis positive, no other activities required at the time of enrollment Screening for sexual infections);
- Patients who had undergone autologous or allogeneic organ or stem cell transplantation; patients who had undergone major surgery or severe trauma within 4 weeks prior to the first dose;
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-16350BPI-16350 capsules administered orally | Drug | 100mg QD, 200mg QD, 300mg QD, 400mg QD, 500mg QD, 50mg QD |
Primary outcome
Participants with Adverse Events
Time frame: 24 months
The safety and tolerability variables include adverse events, physical examinations, vital signs , clinical laboratory evaluations including serum chemistry, hematology , and urinalysis, and electrocardiograms (ECGs) in triplicate,Incidence and nature of DLTs ( dose-limiting toxicity), To determine the MTD (maximum tolerated dose).
3 secondary outcomes
Cmax
Time frame: 1 month
Half-life time
Time frame: 1 month
Tmax
Time frame: Time to Cmax
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.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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-16350 in people with Advanced Solid Cancer, 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 9 inclusion and 17 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: under way, not looking for participants, 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 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?
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants with Adverse Events (time frame: 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 27 Jan 2025.