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New treatment option for Advanced Solid Tumor
Official title A Study of BPI-1178 in Patients With Advanced Solid Tumor and HR+/HER2- Breast Cancer
ClinicalTrials.gov ID: NCT04282031
What this study is testing
What is BPI-1178?
BPI-1178 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for advanced solid tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- BPI-1178 is a novel, orally administered inhibitor of both cyclin-dependent kinase 4（CDK4）and CDK6 kinase activity. This Phase I study is a first-in-human (FIH) clinical trial designed to evaluate the safety, tolerability, and pharmacokinetic (PK) profile of oral BPI-1178 in patients with advanced solid tumors.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Have given written informed consent prior to any study specific procedures.
- Male or female, aged ≥18 years.
- people with advanced solid tumors:
- Phase 1: Histologically or cytologically confirmed, locally advanced (not amenable to curative treatment of surgical resection or radiation therapy)...
- Phase 2a Cohort A: HR+/HER2- locally advanced, recurrent, or metastatic breast cancer with disease progression after first-line endocrine therapy...
You likely can't join if
- Currently receiving or have received any CDK4/6 inhibitors.
- Have had allergies or history of severe allergies.
- Have participated in any clinical trials within 4 weeks prior to the dosing of BPI-1178.
- Have received anti-tumor therapy (including chemotherapy, endocrine therapy, targeted therapy, immunotherapy, tumor embolization, etc.; have received...
- Other malignancies present or previously present at the time of enrollment or still under treatment at the time of enrollment (only applicable to...
- Any toxicity related to previous treatment before enrollment defined by CTCAE (v5.0) Grade≥2 (except hair loss).
See the full eligibility criteria
Who can join
- Have given written informed consent prior to any study specific procedures.
- Male or female, aged ≥18 years.
- people with advanced solid tumors:
- Phase 1: Histologically or cytologically confirmed, locally advanced (not amenable to curative treatment of surgical resection or radiation therapy), recurrent, or metastatic solid tumors that were refractory to...
- Phase 2a Cohort A: HR+/HER2- locally advanced, recurrent, or metastatic breast cancer with disease progression after first-line endocrine therapy (not fulvestrant) or intolerant of it, histologically confirmed by the...
- Phase 2a Cohort B: HR+/HER2- locally advanced, recurrent, or metastatic breast cancer with no prior systemic therapy in this disease setting or relapse more than 1 years from completion of adjuvant endocrine therapy...
- Female patients with breast cancer at Phase IIa must also meet the following criteria: (1) Postmenopausal patients must meet at least one of the following criteria:
- Age ≥ 60 years old;
- Patients \< 60 years of age who have menstruation ceased for at least 12 consecutive months and have not received chemotherapy, tamoxifen, toremifene or ovarian function inhibitors, and have blood estrogen and FSH...
- Previous bilateral ovariectomy;
- Patients \< 60 years of age who are being treated with tamoxifen or toremifene with blood estrogen and FSH levels within the reference range for postmenopausal women. (2) Premenopausal/perimenopausal patients must meet...
- At least 1 measurable lesion based on the RECIST v1.1 criteria.
- Life expectancy≥ 12 weeks.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)≤1.
- Adequate bone marrow and organ function, defined as following:
- absolute neutrophil count≥1.5×10\^9/L, platelets≥100×10\^9/L, hemoglobin≥100 g/L;
- total bilirubin≤1.5×ULN(≤3×ULN for Gilbert syndrome), alanine aminotransferase and aspartate aminotransferase≤3×ULN;
- serum creatinine≤1.5×ULN or a creatinine clearance calculated by Cockcroft-Gault formula≥50 mL/min; urinary protein measured by semi-quantitative method\<2+; if urinary protein measured by semi-quantitative method at...
- activated partial thromboplastin time and international normalized ratio≤1.5×ULN;
- LVEF≥50%;
- Corrected QT interval (QTcF)\<450ms for men and \<470ms for women at resting.
- Female people should take effective contraceptive methods during the study and for 60 days after the last dose of BPI-1178, and must have a negative pregnancy test prior to dosing if of child-bearing potential, or must...
- All people must have enough mental behavior ability, understand the nature and significance of the study, as well as the risks associated with the study.
What rules you out
- Currently receiving or have received any CDK4/6 inhibitors.
- Have had allergies or history of severe allergies.
- Have participated in any clinical trials within 4 weeks prior to the dosing of BPI-1178.
- Have received anti-tumor therapy (including chemotherapy, endocrine therapy, targeted therapy, immunotherapy, tumor embolization, etc.; have received radiotherapy within 2 weeks before taking the investigational...
- Other malignancies present or previously present at the time of enrollment or still under treatment at the time of enrollment (only applicable to Phase IIa study)
- Any toxicity related to previous treatment before enrollment defined by CTCAE (v5.0) Grade≥2 (except hair loss).
- Presence of third interstitial fluid that cannot be controlled by drainage or other methods (such as large amounts of pleural fluid and ascites).
- Requiring long-term treatment of steroid.
- Having uncorrectable hypokalemia and hypomagnesemia at enrollment.
- Meet any of the following criteria: Various clinically significant heart rhythm and conduction abnormalities, such as atrial fibrillation, complete left bundle branch block, Level III conduction block, Level II...
- Known active infection, such as hepatitis B (HBV DNA ≥ 200 IU/mL), hepatitis C, human immunodeficiency virus (HIV) infection.
- Have a history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
- Based on the judgement of investigators, there might be multiple factors which could impact taking and absorption of BPI-1178, including gastrointestinal factors (e.g., obviously uncontrollable inflammatory...
- Have spinal cord compression, metastases of the meninges, or brain metastases with obvious symptoms. The following cases of brain metastases without symptoms can be enrolled: brain metastases without obvious symptoms...
- In the judgment of the investigator, have a concomitant disease (such as severe hypertension, diabetes, thyroid disease, severe infection, portal hypertension, cirrhosis, etc.) that would endanger the people' safety or...
- Have had major surgery (craniotomy, thoracotomy, or laparotomy) or unhealed wounds, ulcers, or fractures within 4 weeks prior to the dosing of BPI-1178.
- Pregnant or lactating women, or fertile women with pregnancy test positive at baseline.
- Any factors that may endanger subject's safety and may affect subject's compliance with the study.
- Drug abuse, alcoholic addiction, medical and mental illness and social barriers judged by investigator, which may interfere the people' participation in the study or affect the evaluation of study endpoints . Any factor...
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.