Clinical Trials in China / NCT06987500
Recruiting
Phase 1/2
A Study of PARG Inhibitor XNW29016 in Patients With Advanced Solid Tumors Who Failed Standard Treatment
NCT06987500 · tracked via the Priya Life Science China tracker
Condition(s) studied
Tumor, Solid
Investigational drug(s) / intervention(s)
XNW29016XNW29016
XNW29016: Oral Medication. The study set 7 dose level cohorts in dose escalation part.
XNW29016: Oral Medication
Study summary
The purpose of this study is to characterize the safety, tolerability, and efficacy of XNW29016 in participants with advanced solid tumors .
Eligibility
Inclusion Criteria:
* Patients must have the ability to understand and sign an approved informed consent form (ICF).
* Age at the time of consent ≥ 18 years;
* Life expectancy of ≥ 3 months;
* For prostate adenocarcinoma, at least one evaluable lesion by RECIST v1.1 and PCWG3 criteria; for other advanced solid tumor, at least one measurable lesion by RECIST v1.1 criteria.
* Agree to provide tumor tissue samples that meet the testing requirements;
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1;
* Phase Ia:Patients with advanced solid tumor confirmed by histological or cytological examination,who have failed standard of care therapy, or are unable to tolerate standard of care therapy, or unable to obtain/unwilling to receive standard therapy.
* Adequate hematologic and non-hematologic function during the screening.
* Women of childbearing potential must have a negative result of serum pregnancy test at screening, and must agree to use a reliable and effective method of contraception during the study and for 6 months after the last dose of the study drug. Male patients must agree to take adequate contraceptive measures from the beginning of the study to at least 6 months after the last dose of the test drug, and prohibit sperm donation;
* Ability to comply with all procedures of the clinical trial protocol.
Exclusion Criteria:
* Any previous treatment with a PARG inhibitor.
* Subjects known to be allergic to the study drug or its active ingredients or excipients;
* Subjects who received anti-tumor therapies including chemotherapy, immunotherapy, radical radiotherapy, major surgery, targeting therapy and other anti-tumor therapies within 4 weeks or 5 half-lives of the drug (whichever is shorter) before the first dose; or received palliative radiotherapy within 2 weeks before the first dose;
* Subjects who participated in any other clinical trial of anti-tumor therapy within 28 days before the first dosing, and the last dose of other anti-tumor trial drug is within 28 days prior to the first administration of study drug in this trial;
* Subjects who underwent major surgery within 4 weeks prior to the start of the study treatment, or who are scheduled to undergo a major surgery during the study period (procedures such as puncture or lymph node biopsy is allowed);
* Subjects who have an allogeneic tissue/ solid organ transplantation;
* Subjects who experienced toxicity events during previous anti-tumor treatment and the toxicity has not resolved (the toxicity events has not been graded as ≤ level 1 according to NCI-CTCAE 5.0). Other toxicities that the investigator does not think it will affect the safety assessment of the subject (such as hair loss, etc.) will be allowed;
* Subjects who have a history of other malignancies within 3 years prior to enrollment and do not meet the criteria for clinical cure.
* Central nervous system metastasis or disease;
* Subjects who have impaired heart functions or clinically serious heart disease;
* Have severe systemic active infection;
* Have a history of tuberculosis within 1 year before enrollment, or had an active TB infection more than 1 year before but not received adequate anti-TB treatment;
* Human immunodeficiency virus (HIV) positive, syphilis (Anti-TB) positive;
* Known acute or chronic active hepatitis B (HBsAg positive or HBcAb positive, and HBV DNA ≥ 200 IU/mL or ≥ 103 copies/mL) or acute or chronic active hepatitis C (HCV antibody positive and positive for HCV RNA test);
* Known impaired gastrointestinal (GI) function or GI diseases that may significantly affect the absorption or metabolism of oral drugs; abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 6 months before the first administration;
* Subjects taking known moderate or strong inducers and inhibitors of CYP3A within 14 days before the first administration;
* Active autoimmune and inflammatory diseases;
* Women who are pregnant or breastfeeding;
* Subjects who are considered unsuitable for the study judged by the investigator.
Primary outcome measure(s)
- Ph Ia/Ib: Overall safety profile including adverse events — Baseline up to approximately 2 years
* Adverse Events will be graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version \[5.0\]) * Incidence of Dose Limiting Toxicities - Ph Ia/Ib: Recommended phase 2 doses (RP2D) of XNW29016 — Approximately 12 months
RP2D of XNW29016 as administered orally twice daily (BID), continuously in 28-day cycles, in subjects by safety data, pharmacokinetic data, pharmacodynamic data and efficacy data
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| 17 South Li, Panjiayuan, Chaoyang District, Beijing City. | Beijing | Beijing Municipality | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06987500 on ClinicalTrials.gov ↗ ← All trials in China