Actively Recruiting
A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of XNW29016 Tablets in Advanced Solid Tumors With Failed Standard Treatment
Led by Evopoint Biosciences Inc. · Updated on 2025-06-06
132
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
E
Evopoint Biosciences Inc.
Lead Sponsor
C
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and effectiveness of XNW29016 in people with advanced solid tumors who have not responded to standard treatments. This open-label, multi-center Phase I/II clinical trial includes dose escalation and expansion phases to find the best dose and assess preliminary effects of XNW29016 tablets. The study aims to gather important data on how the drug works and its impact on different tumor types. Participants receive oral XNW29016 tablets, starting with dose escalation cohorts followed by dose expansion groups. Treatment continues until disease progression or intolerable side effects occur. The study includes a screening period to confirm eligibility, a treatment period with twice-daily dosing, and a follow-up period to monitor ongoing health and treatment effects. During the study, safety is closely monitored through routine blood tests, biochemical tests, and ECGs, with blood collected for pharmacokinetic and pharmacodynamic analysis. Tumor response is evaluated every 8 weeks for the first 48 weeks, then every 12 weeks thereafter. Participants may remain in the study for up to approximately two years to assess safety, tolerability, and response to treatment under careful medical supervision.
CONDITIONS
Brief Title
A Study of PARG Inhibitor XNW29016 in Patients With Advanced Solid Tumors Who Failed Standard Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand and sign an approved informed consent form
- Age 18 years or older at the time of consent
- Life expectancy of at least 3 months
- For prostate adenocarcinoma, at least one evaluable lesion by RECIST v1.1 and PCWG3 criteria; for other advanced solid tumors, at least one measurable lesion by RECIST v1.1 criteria
- Agree to provide tumor tissue samples that meet testing requirements
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
- Advanced solid tumor confirmed by histological or cytological examination, with failed or intolerable standard therapy, or unwilling/unable to receive standard therapy (Phase Ia patients)
- Adequate hematologic and non-hematologic function during screening
- Women of childbearing potential must have a negative serum pregnancy test at screening and agree to use reliable contraception during the study and for 6 months after the last dose
- Male patients must agree to use adequate contraception from study start to 6 months after last dose and avoid sperm donation
- Ability to comply with all study procedures
You will not qualify if you...
- Previous treatment with a PARG inhibitor
- Known allergy to the study drug or its ingredients
- Anti-tumor therapies including chemotherapy, immunotherapy, radiotherapy, major surgery, targeting therapy within 4 weeks or 5 half-lives before first dose; or palliative radiotherapy within 2 weeks before first dose
- Participation in another anti-tumor clinical trial within 28 days before first dose
- Major surgery within 4 weeks prior to study treatment or planned during study (excluding minor procedures like biopsy)
- History of allogeneic tissue or solid organ transplantation
- Unresolved toxicities from previous anti-tumor treatments above grade 1 except for non-serious effects like hair loss
- History of other malignancies within 3 years unless clinically cured
- Central nervous system metastasis or disease
- Impaired heart function or serious heart disease
- Severe active systemic infections
- Tuberculosis history within 1 year before enrollment or untreated active TB
- HIV positive or syphilis positive
- Active hepatitis B or C infection
- Significant gastrointestinal disorders affecting oral drug absorption or metabolism, including recent abdominal fistula, perforation, or abscess
- Use of moderate or strong CYP3A inducers or inhibitors within 14 days before first dose
- Active autoimmune or inflammatory diseases
- Pregnant or breastfeeding women
- Considered unsuitable for the study by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Variable duration until disease progression or intolerable toxicity
Participants receive treatment with XNW29016 tablets until the treatment is discontinued due to disease progression or intolerable toxicity.
1 visit every 8 weeks for the first 48 weeks, then 1 visit every 12 weeks
Duration - Up to approximately 2 years
Participants are monitored for safety and efficacy after treatment ends.
Regular safety and efficacy assessments during follow-up
Trial Site Locations
Total: 1 location
1
17 South Li, Panjiayuan, Chaoyang District, Beijing City.
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
Research Team
B
Bin He principal investigator, Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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