Actively Recruiting
A Study of PARG Inhibitor XNW29016 in Patients With Advanced Solid Tumors Who Failed Standard Treatment
Led by Evopoint Biosciences Inc. · Updated on 2025-06-06
132
Participants Needed
1
Research Sites
122 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
The purpose of this study is to characterize the safety, tolerability, and efficacy of XNW29016 in participants with advanced solid tumors .
CONDITIONS
Official 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...
- Patients must be able to understand and sign an 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 solid tumors, at least one measurable lesion by RECIST v1.1.
- Agree to provide tumor tissue samples for testing.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Patients with advanced solid tumors confirmed by histology or cytology who failed or cannot tolerate standard therapies.
- Adequate blood and organ function at screening.
- Women of childbearing potential must have a negative pregnancy test and agree to effective contraception during the study and for 6 months after.
- Male patients must agree to use contraception during the study and for 6 months after, and not donate sperm.
- Ability to comply with all study procedures.
You will not qualify if you...
- Previous treatment with a PARG inhibitor.
- Allergy to the study drug or its ingredients.
- Antitumor therapies (chemotherapy, immunotherapy, radiotherapy, surgery, targeted therapy) within specified time frames before dosing.
- Participation in other anti-tumor clinical trials within 28 days before dosing.
- Major surgery within 4 weeks before study treatment or planned during the study (except minor procedures).
- History of allogeneic tissue or solid organ transplant.
- Unresolved toxicities from previous cancer treatments above grade 1.
- Other recent malignancies within 3 years not meeting clinical cure criteria.
- Central nervous system metastases.
- Serious heart conditions or impaired heart function.
- Severe active systemic infections.
- Tuberculosis history within 1 year or untreated active TB.
- Positive HIV or syphilis tests.
- Active hepatitis B or C infections.
- Significant gastrointestinal diseases affecting drug absorption.
- Use of strong CYP3A inducers or inhibitors within 14 days before dosing.
- Active autoimmune or inflammatory diseases.
- Pregnancy or breastfeeding.
- Other conditions judged unsuitable by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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.
CONTACT
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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