Evaluating XNW29016 Tablets for Advanced Solid Tumors After Standard Treatment Failure

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

This study is testing if XNW29016 tablets can help people with advanced solid tumors who haven't responded to regular treatments.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 132 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Evopoint Biosciences Inc. (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06987500 on ClinicalTrials.gov

What this trial studies

This open-label, multi-center Phase I/II clinical trial aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of XNW29016 tablets in patients with advanced solid tumors who have not responded to standard treatments. The study consists of a screening period, a treatment period where eligible participants receive XNW29016, and a follow-up period. Safety data will be continuously collected, along with blood samples for pharmacokinetic and pharmacodynamic analysis, while efficacy will be evaluated based on various tumor types and indicators.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with advanced solid tumors who have failed standard therapies or cannot tolerate them.

Not a fit: Patients with early-stage tumors or those who have not yet undergone standard treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors who have exhausted standard treatment options.

How similar studies have performed: Other studies have shown promise with similar approaches in treating advanced solid tumors, indicating potential for success.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing Municipality

• 17 South Li, Panjiayuan, Chaoyang District, Beijing City. — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Bin He principal investigator, Ph.D.

Conditions Tumor, Solid