A Study of PARG Inhibitor XNW29016 in Patients With Advanced Solid Tumors Who Failed Standard Treatment

NCT06987500 | Recruiting Phase 1

• 1 other identifier: XNW29016-I/II-01
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to characterize the safety, tolerability, and efficacy of XNW29016 in participants with advanced solid tumors .

Conditions

Tumor, Solid

Outcome Measures

Primary Outcomes (2)

• Ph Ia/Ib: Overall safety profile including adverse events

  * 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

  Baseline up to approximately 2 years

• Ph Ia/Ib: Recommended phase 2 doses (RP2D) of XNW29016

  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

  Approximately 12 months

Secondary Outcomes (5)

• Ph Ia/Ib: Pharmacokinetic Parameters

  The cycle 0 and first 28-day cycle of therapy

• Ph Ia/Ib: Pharmacokinetic Parameters

  The cycle 0 and first 28-day cycle of therapy

• Ph Ia/Ib: Pharmacokinetic Parameters

  The cycle 0 and first 28-day cycle of therapy

• Ph Ia/Ib: Pharmacodynamic Parameters

  The cycle 0 and first 28-day cycle of therapy

• Overall Response Rate (ORR)

  Baseline up to approximately 2 years

Study Arms (2)

Phase Ia: Monotherapy Dose Escalation

EXPERIMENTAL

Participants will receive XNW29016 at escalating dose levels

Drug: XNW29016

Phase Ib: Monotherapy Dose Expansion

EXPERIMENTAL

The patient will be enrolled into several groups and take XNW29016 tablet twice a day. The subject of this part is to optimize dosage and definite RP2D.

Drug: XNW29016

Interventions

XNW29016 DRUG

Oral Medication. The study set 7 dose level cohorts in dose escalation part.

Also known as: PARGi

Phase Ia: Monotherapy Dose Escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Evopoint Biosciences Inc.: lead
• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: collaborator

Study Sites (1)

17 South Li, Panjiayuan, Chaoyang District, Beijing City.

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Bin He principal investigator, Ph.D.

CONTACT

010-87788495; xubinghe@medmail.com.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2025
• First Posted: May 23, 2025
• Study Start: April 11, 2025
• Primary Completion (Estimated): February 14, 2027
• Study Completion (Estimated): August 16, 2027
• Last Updated: June 6, 2025

Record last verified: 2025-04

Locations

CN (1)