AzTrials
AzTrials

Advanced Solid TumorsPhase 1/2NCT07327294

A Phase I/II Study to Evaluate XNW34017 in Patients With Advanced or Metastatic Solid Tumor

A Phase 1/2 study testing XNW34017 in people with Advanced Solid Tumors, run by Evopoint Biosciences Inc. at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This study is an open-label, dose-escalation, multicenter Phase I/II study conducted in patients with advanced solid tumors. The target population for this study consists of patients with advanced solid tumors who have failed or are intolerant to standard treatments. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumors
What is being tested?
XNW34017
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteChina
Study dates
31 Jan 2026to 30 Jun 2028
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

  • Dose escalation phase: Subjects with advanced and/or metastatic malignant solid tumors who have failed standard treatment or lack effective standard treatment, and have histologically or cytologically confirmed diagnosis.
  • Dose expansion phase, including but not limited to: Advanced and/or metastatic small cell lung cancer, prostate cancer, etc., with disease progression confirmed by histopathology, and failure in the following anti-cancer treatments:
  • Small cell lung cancer: Patients with small cell lung cancer who have progressed or relapsed after receiving at least two prior systemic treatment regimens.
  • Metastatic castration-resistant prostate cancer (mCRPC): Patients who have previously received treatment with enzalutamide or abiraterone and have experienced disease progression. At screening, serum testosterone should be at castration levels (≤ 50 ng/dL or ≤ 1.73 nmol/L). For patients who have not undergone bilateral orchiectomy, LHRHa therapy should be administered ≥ 4 weeks prior to the first dose of study treatment and continued throughout the study.
  • The subject must be ≥ 18 years of age at the time of signing the informed consent.
  • At least one measurable lesion according to RECIST 1.1 criteria (applicable to the backfill cohort and dose expansion phase).
Show all 13Show fewer
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1.
  • The subject's organ function levels must meet the following requirements within 7 days prior to the first dose:
  • Absolute Neutrophil Count (ANC) ≥ 1.5×10^9/L, Platelet Count ≥ 100×10^9/L, Hemoglobin ≥ 90 g/L; Creatinine Clearance ≥ 60 ml/min (calculated using the Cockcroft-Gault formula) or Serum Creatinine (Cr) ≤ 1.5 times the upper limit of normal; Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) levels ≤ 2.5 times the upper limit of normal (ULN), for liver cancer/liver metastasis patients, AST/ALT should be ≤ 5×ULN; Total Bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN), for patients with Gilbert's Syndrome, Direct Bilirubin (DBIL) must be ≤ 2×ULN; International Normalized Ratio (INR) ≤ 1.2 (without anticoagulant treatment), Activated Partial Thromboplastin Time (APTT) ≤ 1.25×ULN; for subjects who have been on stable-dose anticoagulant therapy (e.g., warfarin) for ≥8 weeks, INR must be ≤3.
  • Life expectancy ≥ 12 weeks.
  • Female participants of childbearing potential must undergo a urine or serum pregnancy test within 7 days prior to starting the study medication, and the result must be negative. If the urine pregnancy test is positive or inconclusive, a serum pregnancy test must be performed.
  • During the study and for 6 months after the last dose of the study drug, an effective, medically approved contraception method (e.g., intrauterine device, contraceptive pills, or condoms) must be used. For male participants with a female partner of childbearing potential, they must either be surgically sterilized or agree to use an effective contraception method during the study and for 6 months after the last dose of the study drug. Additionally, male participants must agree not to donate sperm throughout their study participation and for at least 6 months after their last dose of study drug.
  • The participant has given informed consent and has signed the informed consent form, and is willing and able to comply with the study procedures required by the protocol.

Who cannot join

  • Individuals who have had an allergic reaction to any component of the XNW34017.
  • The washout period of prior antitumor treatments before the first study drug treatment is insufficient, defined as follows:
  • Chemotherapy, small molecule targeted therapy, or endocrine therapy < 2 weeks or 5 half-lives, whichever is shorter; Monoclonal antibody therapy < 3 weeks; Brain radiotherapy < 2 weeks, palliative radiotherapy < 2 weeks, curative radiotherapy < 4 weeks.
  • Subjects with double primary malignant tumors, except for the specific cancer being studied in this trial and any previously cured local tumors: non-invasive basal cell carcinoma or squamous cell carcinoma, non-invasive superficial bladder cancer, and any other tumors with a complete remission (CR) lasting more than 5 years.
  • Receiving a live vaccine within 4 weeks prior to the first study drug treatment. Note: Seasonal flu vaccines are generally inactivated vaccines and can be used; however, intranasal flu vaccines, which are live attenuated vaccines, are not permitted.
  • Use of granulocyte colony-stimulating factor (G-CSF) or granulocyte/macrophage colony-stimulating factor within 1 week prior to the first study drug treatment, or use of pegylated G-CSF within 2 weeks prior to the first study drug treatment. Receiving blood transfusion treatment within 2 weeks prior to the first study drug treatment. Use of erythropoietin (EPO) or IL-11 within 1 week prior to the first study drug treatment.
Show all 12Show fewer
  • Subjects who have not yet recovered from the toxicity of prior anticancer treatments to CTCAE grade ≤ 1 or a stable condition, except for AEs that are not considered to pose a safety risk (e.g., hair loss).
  • A history of intracranial arteriovenous malformation, cerebral aneurysm, or stroke (including transient ischemic attack within 1 month prior to screening, but excluding old cerebral infarction and asymptomatic cerebral infarction).
  • Presence of any of the following hematologic risk factors:
  • Known coagulation defects leading to an increased risk of bleeding; Diffuse alveolar hemorrhage caused by vasculitis; Persistent major bleeding; Trauma resulting in an increased risk of life-threatening bleeding; A history of severe extracranial injury or intracranial surgery within 8 weeks prior to the start of the trial.
  • Unable to provide tumor tissue samples for biomarker expression testing (for subjects unable to provide tissue samples, enrollment may be determined through consultation between the investigator and the sponsor).
  • Presence of clinically significant cardiovascular or cerebrovascular diseases:History of unstable angina;Myocardial infarction within 6 months prior to screening;Underwent angioplasty or coronary stent treatment within 6 months prior to screening;History of congestive heart failure with New York Heart Association (NYHA) classification of 3 - 4;Baseline QTc interval abnormality (QTcF > 450 ms);Occurrence of ≥ grade 2 ventricular arrhythmia within 6 months prior to screening;Poorly controlled hypertension: systolic blood pressure > 150 mmHg or diastolic blood pressure > 100 mmHg despite standard antihypertensive treatment;Presence of cardiac disease/history that results in left ventricular ejection fraction (LVEF) < 50%.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Li Zhang, PhD, MD contact

+86 020-87343458

zhangli@sysucc.org.cn

Qiye Wang contact

+86 18036617186

qiye.wang@evopointbio.com

China1 site

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510000

    Li Zhang, PhD, MD, +86 020-87343458, zhangli@sysucc.org.cn

Other trials in China

About this study

Official title: An Open-label, Multicenter Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of XNW34017 in Patients With Advanced Solid Tumors

This study is an open-label, dose-escalation, multicenter Phase I/II study conducted in patients with advanced solid tumors. The target population for this study consists of patients with advanced solid tumors who have failed or are intolerant to standard treatments. The study is divided into two parts: the dose-escalation phase and the dose-expansion phase.

Being tested
XNW34017

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • XNW34017Drug

    Drug Name: XNW34017 Tablets Dosage Form: Tablet Strength: 5 mg, 50 mg Route of Administration: Oral Storage Instructions: Store in a sealed container, protected from light, at temperatures not exceeding 30°C.

Study groups in NCT07327294
Study groupRoleWhat they receive
XNW34017ExperimentalNot described
Receives: Drug: XNW34017

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The incidence and severity of AEs and SAEs

    The incidence and severity of AEs and SAEs

    Measured: 24 months

  2. ORR

    ORR assessed by investigator

    Measured: 24 months

Secondary outcomes (5)

  1. Plasma concentrations of XNW34017

    Plasma concentrations of XNW34017

    Measured: 8 months

  2. DCR

    Disease control rate (DCR)

    Measured: 24 months

  3. DOR

    Duration of Response (DOR)

    Measured: 24 months

  4. PFS

    Progression Free Survival (PFS)

    Measured: 24 months

  5. OS

    Overall Survival(OS)

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jan 2026
  2. Study start31 Jan 2026 (estimated)
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion30 Jun 2028 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07327294
Sponsor's protocol ID
XNW34017-I/II-01
Status last verified
Dec 2025
First submitted
12 Dec 2025
Last updated
8 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing XNW34017 in people with Advanced Solid Tumors, 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 13 inclusion and 12 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: opening soon, as of the sponsor's last update on 8 Jan 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 Li Zhang, PhD, MD (+86 020-87343458, zhangli@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence and severity of AEs and SAEs (time frame: 24 months). 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?

On the ClinicalTrials.gov record for NCT07327294.

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 8 Jan 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in