Actively Recruiting
A Phase l Study of By101921, an Oral PARP7 Inhibitor, in Patients With Advanced Solid Tumors
Led by Chengdu Baiyu Pharmaceutical Co., Ltd. · Updated on 2024-05-30
60
Participants Needed
1
Research Sites
94 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
BY101921 is a novel small molecule, being developed as a PARP7 inhibitor which acts on the PARP7 catalytic subunit, for the treatment of solid tumors. PARP7 is a member of the monoPARP family and involved in various biological processes such as gene expression, protein degradation, and cellular stress response. The results of non-clinical studies showed BY101921 was a potent inhibitor of PARP7 and had good selectivity. The primary objective is to assess the safety and tolerability and MTD of BY101921 in patients with refractory or metastatic solid tumors. This study will also evaluate pharmacokinetic (PK) profile, preliminary anti-tumor activity, major metabolites and biomarkers in patients with refractory or metastatic solid tumors.
CONDITIONS
Official Title
A Phase l Study of By101921, an Oral PARP7 Inhibitor, in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients aged 18 to 75 years
- Histologically or cytologically confirmed advanced malignant solid tumors that have failed, cannot tolerate, or refuse prior standard treatments
- At least one measurable lesion according to RECIST v1.1 criteria
- Expected life expectancy of at least 3 months
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
- Adequate organ and bone marrow function meeting specified laboratory criteria within 7 days before first dose without recent transfusions or growth factor treatments
- Females and males of childbearing potential agreeing to use effective contraception during the study and for 3 months after last dose
- Female participants of childbearing potential must have a negative serum pregnancy test within 7 days prior to dosing
- Ability to understand and sign informed consent and comply with study procedures
You will not qualify if you...
- Prior treatment with PARP-7 inhibitors
- Use of potent CYP3A4 inhibitors or inducers within 2 weeks before first dose
- Recent systemic chemotherapy, antitumor agents, small molecule targeted therapy, traditional Chinese medicine, nitrosourea or mitomycin C, radiation therapy, investigational drugs, or radical radiation therapy within specified washout periods before first dose
- Major surgery within 28 days before study drug administration or unhealed surgical wounds
- Presence of brain metastases (unless asymptomatic and stable for more than 4 weeks without steroid therapy), meningeal or brainstem metastases, or spinal cord compression
- History of other malignancies within 5 years except certain treated skin or cervical carcinomas in situ
- Unresolved toxicities from prior antitumor therapy above grade 1 except specified exceptions
- Difficult-to-control pleural effusion, ascites, or pericardial effusion requiring repeated drainage
- Serious or uncontrolled diseases including severe diabetes, uncontrolled hypertension, epilepsy, chronic obstructive pulmonary disease, interstitial lung diseases, Parkinson's disease, active bleeding, uncontrolled infection, cognitive dysfunction, psychiatric disorders, alcohol or drug abuse, immunodeficiency, or history of organ transplantation
- Positive hepatitis B or C serology with elevated viral loads or positive treponema pallidum antibody
- Serious gastrointestinal dysfunction affecting drug intake or absorption
- Cardiac dysfunction including recent myocardial infarction, heart failure class II-IV, unstable angina or arrhythmia, left ventricular ejection fraction below 50%, or prolonged QT interval
- Pregnancy or breastfeeding
- History of serious hypersensitivity reactions to the study drug or its components
- Inability to avoid grapefruit, pomegranate, orange, or green lemon products during treatment
- Other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Cancer Hospital Affiliated to Shandong First Medical University / Shandong Cancer Research Institute / Shandong Cancer Hospital
Jinan, Shandong, China, 250117
Actively Recruiting
Research Team
J
Jinming Yu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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