Can a Twice-Daily pill crack tumors that resist standard treatment?

NCT ID NCT06987500

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Oct 16, 2026 · Last updated Oct 16, 2026

Summary

Researchers are testing an experimental oral drug called XNW29016 in adults with advanced solid tumors that have not responded to standard treatment. The trial has two parts: a dose-escalation phase to find a safe dose and a dose-expansion phase to look at early signs of activity. Participants take the tablet twice daily in 28-day cycles, and the study tracks side effects, how the body processes the drug, and any changes in tumors.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
an experimental oral drug called XNW29016, a PARG inhibitor
What this could lead to
If it works, this could point toward a new oral option for people whose advanced solid tumors have stopped responding to standard treatment.
What could go wrong
This is an early-phase trial, so the main goal is checking safety and finding a dose, not proving the drug works. Many cancer drugs at this stage turn out to be too toxic or not effective enough, and results in a small group may not hold up in larger studies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 132 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

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

    RECRUITING

    Beijing, Beijing Municipality, 100021, China

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