Tumor, SolidPhase 1/2NCT06987500
A Study of PARG Inhibitor XNW29016 in Patients With Advanced Solid Tumors Who Failed Standard Treatment
A Phase 1/2 study testing XNW29016 in people with Tumor, Solid, run by Evopoint Biosciences Inc. at 1 site in China.
Trial summary
The purpose of this study is to characterize the safety, tolerability, and efficacy of XNW29016 in participants with advanced solid tumors . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tumor, Solid
- What is being tested?
- XNW29016
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteChina
- Study dates
- 11 Apr 2025to 16 Aug 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
17 South Li, Panjiayuan, Chaoyang District, Beijing City.
Beijing, Beijing Municipality, 100021
About this study
Official title: 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
The purpose of this study is to characterize the safety, tolerability, and efficacy of XNW29016 in participants with advanced solid tumors .
Read the detailed description
This study is an open-label, multi-center Phase I/II clinical trial. Phase I includes the dose escalation (Stage Ia) and dose expansion (Stage Ib) phases; Phase II is an open-label, multi-center, single-arm basket study to evaluate the efficacy and safety of XNW29016 tablets in subjects with the target indications.
This study consists of a screening period, a treatment period, and a follow-up period. Subjects who meet the eligibility criteria during the screening period will enter the treatment period and receive treatment with XNW29016 tablets until the study treatment is discontinued due to reasons such as disease progression or intolerable toxicity.
Safety data (such as routine blood tests, routine biochemical tests, ECG, etc.) will be continuously collected during the study, and blood samples for PK (pharmacokinetics), PD (pharmacodynamics), etc. will also be collected. Efficacy evaluation will be based on different tumor types and collect different indicators. The efficacy evaluation will be conducted once every 8 weeks in the first 48 weeks from the start of the study treatment, and then once every 12 weeks.
- Conditions
- Tumor, Solid
- Being tested
- XNW29016
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XNW29016Drug
Also called PARGi
Oral Medication. The study set 7 dose level cohorts in dose escalation part.
XNW29016Drug
Also called PARGi
Oral Medication
| Study group | Role | What they receive |
|---|---|---|
| Phase Ia: Monotherapy Dose Escalation | Experimental | Participants will receive XNW29016 at escalating dose levels Receives: 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. Receives: Drug: XNW29016 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Approximately 12 months
Secondary outcomes (5)
Ph Ia/Ib: Pharmacokinetic Parameters
The area under the plasma concentration-time curve (AUC)
Measured: The cycle 0 and first 28-day cycle of therapy
Ph Ia/Ib: Pharmacokinetic Parameters
Maximum plasma concentration (Cmax)
Measured: The cycle 0 and first 28-day cycle of therapy
Ph Ia/Ib: Pharmacokinetic Parameters
Elimination half-life (t1/2)
Measured: The cycle 0 and first 28-day cycle of therapy
Ph Ia/Ib: Pharmacodynamic Parameters
The relative change of PAR with the baseline before and after administration
Measured: The cycle 0 and first 28-day cycle of therapy
Overall Response Rate (ORR)
ORR was defined as the proportion of participants with Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR). ORR was based on RECIST 1.1 response for patients with measurable disease at baseline reviewed by the investigator.
Measured: Baseline up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start11 Apr 2025
- Primary completion14 Feb 2027 (estimated)
- Study completion16 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tumor, SolidStudies of the same condition, open and under way.
- More trials run by Evopoint Biosciences Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Evopoint Biosciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06987500
- Sponsor's protocol ID
- XNW29016-I/II-01
- Status last verified
- Oct 2026
- First submitted
- 25 Apr 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06987500
- Acronym / sponsor ID
- XNW29016-I/II-01
- Conditions
- Tumor, Solid
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Evopoint Biosciences Inc.Industry (pharma, biotech, devices)
- Collaborators
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Study start
- 11 Apr 2025 (actual)
- Primary completion
- 14 Feb 2027 (estimated)
- Study completion
- 16 Aug 2027 (estimated)
- First posted
- 23 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to characterize the safety, tolerability, and efficacy of XNW29016 in participants with advanced solid tumors .
Detailed description
This study is an open-label, multi-center Phase I/II clinical trial. Phase I includes the dose escalation (Stage Ia) and dose expansion (Stage Ib) phases; Phase II is an open-label, multi-center, single-arm basket study to evaluate the efficacy and safety of XNW29016 tablets in subjects with the target indications.
This study consists of a screening period, a treatment period, and a follow-up period. Subjects who meet the eligibility criteria during the screening period will enter the treatment period and receive treatment with XNW29016 tablets until the study treatment is discontinued due to reasons such as disease progression or intolerable toxicity.
Safety data (such as routine blood tests, routine biochemical tests, ECG, etc.) will be continuously collected during the study, and blood samples for PK (pharmacokinetics), PD (pharmacodynamics), etc. will also be collected. Efficacy evaluation will be based on different tumor types and collect different indicators. The efficacy evaluation will be conducted once every 8 weeks in the first 48 weeks from the start of the study treatment, and then once every 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase Ia: Monotherapy Dose Escalation | Experimental | Drug: XNW29016Participants will receive XNW29016 at escalating dose levels |
| Phase Ib: Monotherapy Dose Expansion | Experimental | Drug: XNW29016The 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (19 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XNW29016Also: PARGiOral Medication. The study set 7 dose level cohorts in dose escalation part. | Drug | Phase Ia: Monotherapy Dose Escalation |
| XNW29016Also: PARGiOral Medication | Drug | Phase Ib: Monotherapy Dose Expansion |
Primary outcome
Ph Ia/Ib: Overall safety profile including adverse events
Time frame: 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
Time frame: 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
5 secondary outcomes
Ph Ia/Ib: Pharmacokinetic Parameters
Time frame: The cycle 0 and first 28-day cycle of therapy
Ph Ia/Ib: Pharmacokinetic Parameters
Time frame: The cycle 0 and first 28-day cycle of therapy
Ph Ia/Ib: Pharmacokinetic Parameters
Time frame: The cycle 0 and first 28-day cycle of therapy
Ph Ia/Ib: Pharmacodynamic Parameters
Time frame: The cycle 0 and first 28-day cycle of therapy
Overall Response Rate (ORR)
Time frame: Baseline up to approximately 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing XNW29016 in people with Tumor, Solid, run by Evopoint Biosciences Inc. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bin He principal investigator, Ph.D. (010-87788495, xubinghe@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ph Ia/Ib: Overall safety profile including adverse events (time frame: Baseline up to approximately 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.