Advanced Solid TumorsPhase 1/2NCT06799637
Study of XNW28012 in Subjects With Advanced Solid Tumors Who Failed Standard Treatments
A Phase 1/2 study testing XNW28012 in people with Advanced Solid Tumors and Pancreatic Carcinoma, run by Evopoint Biosciences Inc. at 24 sites in China.
Trial summary
This is an open-label, dose escalation, multicenter, phase 1, first-in-human study of XNW28012 in subjects with advanced solid tumors who have failed current standard anti-tumor therapies or are intolerant to such therapies. The study consists of two parts: a dose escalation part and a dose expansion part. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors, Pancreatic Carcinoma, Ovarian Cancer
- What is being tested?
- XNW28012
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 24 sitesChina
- Study dates
- 1 Dec 2023to 31 Dec 2026
- 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
- For the dose escalation part: subjects with histologically or cytologically confirmed advanced and/or metastatic solid tumors who have failed the established standard anti-cancer therapies for a given tumor type or have been intolerant to such therapies.
- For the dose expansion part: subjects must have a histological or cytological diagnosis of progressive, locally advanced, and/or metastatic ovarian cancer, cervical cancer, pancreatic cancer, or colorectal cancer (CRC) who have failed the following anti-cancer therapies: Ovarian cancer, Cervical cancer, Pancreatic cancer, Colorectal cancer.
- Age ≥ 18 years old at the time of consent.
- Subjects must have at least 1 measurable lesion as defined per RECIST version 1.1 (for dose expansion part only).
- Subjects must have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale. ECOG status of 2 can be allowed if it is a result of disease progression and warrants discussion with the medical monitor.
- Subjects must have adequate organ function within 7 days prior to the first study drug administration, as indicated by the flaboratory values:
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- Life expectancy of at least 12 weeks.
- Females of childbearing potential must have a negative pregnancy test within 7 days prior to the first dose of study drug. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- Non-sterile subjects must be willing to use a highly effective contraception (e.g., IUD, pill, or condom) for the duration of the study and for 6 months after the last dose of study drug unless their partner is sterilized.
- Subjects are able to provide written informed consent, understand and are willing to comply with the requirements of the study.
Who cannot join
- A history of severe infusion reactions to other monoclonal antibodies/antibody drug conjugates (ADCs) or allergic reactions to any components of XNW28012.
- Any anti-tumor therapy within 28 days prior to the first dose, including but not limited to: small molecules, immunotherapy, chemotherapy, monoclonal antibodies, or any other experimental drugs.
- Any active malignancy, with the exception of the specific types of cancers under investigation in this study and any locally recurring cancer that has been treated curatively .
- Have received a live vaccine within 4 weeks prior to the first dose of study drug. Note: Seasonal vaccines for influenza are generally inactivated vaccines and are allowed; however, intranasal influenza vaccines will not be allowed if they are attenuated live vaccines.
- Have received granulocyte colony stimulating factor (G-CSF) or granulocyte / macrophage colony stimulating factor support within 1 week before screening, or pegylated G-CSF within 2 weeks before screening.
- Subjects with toxicities (as a result of prior anti-cancer therapy) which have not improved to CTCAE grade ≤1 or stabilized, except those AEs not considered as a likely safety risk (e.g., alopecia).
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- Any history of intracerebral arteriovenous malformation, cerebral aneurysm, or stroke (transient ischemic attack) ≤ 3 months prior to screening is allowed if stable.
- Any of the hematological risk factors:
- Subjects who are unwilling or unable to provide tumor tissue samples that meet the requirements for tissue factor (TF) expression testing.
- 11. Clinically significant cardiovascular/cerebrovascular conditions. 12. Active ocular surface disease at screening, or subjects with any prior episode of cicatricial conjunctivitis.
- 13. Any history of Toxic Epidermal Necrolysis (TEN) or Steven Johnson Syndrome. 14. Subjects who have undergone major surgery within 28 days prior to the first dose of study drug, except if the procedure is minimally invasive (for example, introduction of peripherally inserted central catheter [PICC] line).
- and so on.
Trial locations and contacts
24 sites in 1 country. Contact the study team or a site near you to ask about taking part.
24 sites in 1 country
China24 sites, 24 recruiting
- Recruiting
Affiliated Hospital of Hebei University
Baoding, Hebei
- Recruiting
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality
- Recruiting
Affiliated Hospital of Binzhou Medical College
Binzhou, Shandong
- Recruiting
Hunan Cancer Hospital
Changsha, Hunan
- Recruiting
The Second Xiangya Hospital Of Central South University
Changsha, Hunan
- Recruiting
Sichuan Provincial People's Hospital
Chengdu, Sichuan
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan
- Recruiting
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality
- Recruiting
Fujian Provincial Cancer Hospital
Fuzhou, Fujian
- Recruiting
First Affiliated Hospital of Gannan Medical College
Ganzhou, Jiangxi
- Recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong
- Recruiting
Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou
- Recruiting
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang
- Recruiting
Affiliated Cancer Hospital of Harbin Medical University
Harbin, Heilongjiang
- Recruiting
Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui
- Recruiting
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui
- Recruiting
Jinan Central Hospital
Jinan, Shandong
- Recruiting
Yunnan Cancer Hospital
Kunming, Yunnan
- Recruiting
Linyi Cancer Hospital
Linyi, Shandong
- Recruiting
First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality
- Recruiting
Hubei Cancer Hospital
Wuhan, Hubei
- Recruiting
First Affiliated Hospital of Kunming Medical University
Yunnan, Kunming
About this study
Official title: A Phase 1, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Efficacy of XNW28012 in Subjects With Advanced Solid Tumors
This is an open-label, dose escalation, multicenter, phase 1, first-in-human study of XNW28012 in subjects with advanced solid tumors who have failed current standard anti-tumor therapies or are intolerant to such therapies. The study consists of two parts: a dose escalation part and a dose expansion part.
- Being tested
- XNW28012
- Keywords
- XNW28012
- Medical subject headings
- Pancreatic Neoplasms, Ovarian Neoplasms, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XNW28012Drug
Eligible subjects will receive XNW28012 every 3 weeks (Q3W) until intolerant toxicity, progression of disease with no clinical benefit, or withdrawal of informed consent.
| Study group | Role | What they receive |
|---|---|---|
| Bayesian Optimal Interval (BOIN) method will be used for the dose escalation part. | Other | Based on the toxicology data from preclinical studies, the Bayesian Optimal Interval (BOIN) method will be used for the dose escalation part with preset doses at 0.6 mg/kg, 1.2 mg/kg, 2.4 mg/kg, 3.6 mg/kg, 4.8 mg/kg, 6.0 mg/kg, and 7.5 mg/kg. Eligible subjects will receive XNW28012 every 3 weeks (Q3W) until intolerant toxicity, progression of disease with no clinical benefit, or withdrawal of informed consent. The first treatment cycle will be the dose limiting toxicity (DLT) assessment period. The safety, tolerability, and occurrence of DLTs will be assessed during the DLT period. The proposed dose escalation plan is shown below. Receives: Drug: XNW28012 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ph 1: Incidence and severity of treatment-emergent adverse events (AEs) [Safety and Tolerability].
Incidence and severity of adverse events that are graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
Measured: through study completion, an average of 1 year
Ph 2: To evaluate the antitumor efficacy of XNW28012 at the recommended Part 2 dose.
ORR per RECIST1.1 assessed by Investigators.
Measured: through study completion, an average of 1 year
Secondary outcomes (9)
Ph 1:Maximum tolerated dose (MTD) and/or the recommended Part 2 dose.
To determine the maximum tolerated dose (MTD) and the recommended Part 2 dose with XNW28012;
Measured: The first 21-day cycle of therapy
Ph 1/II: Maximum (peak) observed concentration (Cmax) of XNW28012.
Blood samples were collected at specified intervals for the determination of Cmax.
Measured: through study completion, an average of 1 year
Ph 1/II: Maximum (peak) observed concentration (Cmax) of total antibody of XNW28012..
Blood samples were collected at specified intervals for the determination of Cmax.
Measured: through study completion, an average of 1 year
Ph 1/II: Maximum (peak) observed concentration (Cmax) of YL0010014
Blood samples were collected at specified intervals for the determination of Cmax.
Measured: through study completion, an average of 1 year
Ph 1/II: Anti-drug antibody (ADA)
To assess the incidence of anti-drug antibody (ADA) against XNW28012
Measured: through study completion, an average of 1 year
Ph I/II：Objective response rate (ORR)
ORR is defined as the proportion of subjects who have a confirmed CR or a PR per RECIST 1.1 assessed by Investigator.
Measured: Efficacy assessments will be performed at screening (≤ 28 days prior to the first dose), every 6 weeks for 24 weeks after the first dose, and every 12 weeks after the 24 weeks response assessments until disease progression (up to 1 year).
Ph I/II: Disease control rate (DCR)
Rate of complete response [CR], partial response [PR], and stable disease per RECIST1.1 assessed by Investigator.
Measured: Efficacy assessments will be performed at screening (≤ 28 days prior to the first dose), every 6 weeks for 24 weeks after the first dose, and every 12 weeks after the 24 weeks response assessments until disease progression (up to 1 year).
Ph I/II：Progression free survival (PFS)
Progression free survival (PFS) per RECIST1.1 assessed by Investigator
Measured: Efficacy assessments will be performed at screening (≤ 28 days prior to the first dose), every 6 weeks for 24 weeks after the first dose, and every 12 weeks after the 24 weeks response assessments until disease progression (up to 1 year).
Ph I/II: Duration of response (DOR)
Duration of response (DOR) per RECIST1.1 assessed by Investigator.
Measured: Efficacy assessments will be performed at screening (≤ 28 days prior to the first dose), every 6 weeks for 24 weeks after the first dose, and every 12 weeks after the 24 weeks response assessments until disease progression (up to 1 year).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start1 Dec 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 350 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
- NCT06799637
- Sponsor's protocol ID
- XNW28012-I/II-01
- Status last verified
- Apr 2026
- First submitted
- 25 Dec 2024
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Efficacy of XNW28012 in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06799637
- Acronym / sponsor ID
- XNW28012-I/II-01
- Keywords
- XNW28012
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Evopoint Biosciences Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 29 Jan 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.
This is an open-label, dose escalation, multicenter, phase 1, first-in-human study of XNW28012 in subjects with advanced solid tumors who have failed current standard anti-tumor therapies or are intolerant to such therapies. The study consists of two parts: a dose escalation part and a dose expansion part.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bayesian Optimal Interval (BOIN) method will be used for the dose escalation part. | Other | Drug: XNW28012Based on the toxicology data from preclinical studies, the Bayesian Optimal Interval (BOIN) method will be used for the dose escalation part with preset doses at 0.6 mg/kg, 1.2 mg/kg, 2.4 mg/kg, 3.6 mg/kg, 4.8 mg/kg, 6.0 mg/kg, and 7.5 mg/kg. Eligible subjects will receive XNW28012 every 3 weeks (Q3W) until intolerant toxicity, progression of disease with no clinical benefit, or withdrawal of informed consent. The first treatment cycle will be the dose limiting toxicity (DLT) assessment period. The safety, tolerability, and occurrence of DLTs will be assessed during the DLT period. The proposed dose escalation plan is shown below. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- For the dose escalation part: subjects with histologically or cytologically confirmed advanced and/or metastatic solid tumors who have failed the established standard anti-cancer therapies for a given tumor type or have been intolerant to such therapies.
- For the dose expansion part: subjects must have a histological or cytological diagnosis of progressive, locally advanced, and/or metastatic ovarian cancer, cervical cancer, pancreatic cancer, or colorectal cancer (CRC) who have failed the following anti-cancer therapies: Ovarian cancer, Cervical cancer, Pancreatic cancer, Colorectal cancer.
- Age ≥ 18 years old at the time of consent.
- Subjects must have at least 1 measurable lesion as defined per RECIST version 1.1 (for dose expansion part only).
- Subjects must have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale. ECOG status of 2 can be allowed if it is a result of disease progression and warrants discussion with the medical monitor.
Key exclusion criteria (12 listed)
- A history of severe infusion reactions to other monoclonal antibodies/antibody drug conjugates (ADCs) or allergic reactions to any components of XNW28012.
- Any anti-tumor therapy within 28 days prior to the first dose, including but not limited to: small molecules, immunotherapy, chemotherapy, monoclonal antibodies, or any other experimental drugs.
- Any active malignancy, with the exception of the specific types of cancers under investigation in this study and any locally recurring cancer that has been treated curatively .
- Have received a live vaccine within 4 weeks prior to the first dose of study drug. Note: Seasonal vaccines for influenza are generally inactivated vaccines and are allowed; however, intranasal influenza vaccines will not be allowed if they are attenuated live vaccines.
- Have received granulocyte colony stimulating factor (G-CSF) or granulocyte / macrophage colony stimulating factor support within 1 week before screening, or pegylated G-CSF within 2 weeks before screening.
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 |
|---|---|---|
| XNW28012Eligible subjects will receive XNW28012 every 3 weeks (Q3W) until intolerant toxicity, progression of disease with no clinical benefit, or withdrawal of informed consent. | Drug | Bayesian Optimal Interval (BOIN) method will be used for the dose escalation part. |
Primary outcome
Ph 1: Incidence and severity of treatment-emergent adverse events (AEs) [Safety and Tolerability].
Time frame: through study completion, an average of 1 year
Incidence and severity of adverse events that are graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
Ph 2: To evaluate the antitumor efficacy of XNW28012 at the recommended Part 2 dose.
Time frame: through study completion, an average of 1 year
ORR per RECIST1.1 assessed by Investigators.
9 secondary outcomes
Ph 1:Maximum tolerated dose (MTD) and/or the recommended Part 2 dose.
Time frame: The first 21-day cycle of therapy
Ph 1/II: Maximum (peak) observed concentration (Cmax) of XNW28012.
Time frame: through study completion, an average of 1 year
Ph 1/II: Maximum (peak) observed concentration (Cmax) of total antibody of XNW28012..
Time frame: through study completion, an average of 1 year
Ph 1/II: Maximum (peak) observed concentration (Cmax) of YL0010014
Time frame: through study completion, an average of 1 year
Ph 1/II: Anti-drug antibody (ADA)
Time frame: through study completion, an average of 1 year
Ph I/II：Objective response rate (ORR)
Time frame: Efficacy assessments will be performed at screening (≤ 28 days prior to the first dose), every 6 weeks for 24 weeks after the first dose, and every 12 weeks after the 24 weeks response assessments until disease progression (up to 1 year).
Ph I/II: Disease control rate (DCR)
Time frame: Efficacy assessments will be performed at screening (≤ 28 days prior to the first dose), every 6 weeks for 24 weeks after the first dose, and every 12 weeks after the 24 weeks response assessments until disease progression (up to 1 year).
Ph I/II：Progression free survival (PFS)
Time frame: Efficacy assessments will be performed at screening (≤ 28 days prior to the first dose), every 6 weeks for 24 weeks after the first dose, and every 12 weeks after the 24 weeks response assessments until disease progression (up to 1 year).
Ph I/II: Duration of response (DOR)
Time frame: Efficacy assessments will be performed at screening (≤ 28 days prior to the first dose), every 6 weeks for 24 weeks after the first dose, and every 12 weeks after the 24 weeks response assessments until disease progression (up to 1 year).
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 15 Apr 2026.
- Individual participant dataSharing planned: No
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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.
24 sites 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 XNW28012 in people with Advanced Solid Tumors and Pancreatic Carcinoma, run by Evopoint Biosciences Inc. at 24 sites 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 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: looking for participants now, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites 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 Yingjie zhao Yingjie Zhao (+86 15553136593, yingjie.zhao@evopointbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ph 1: Incidence and severity of treatment-emergent adverse events (AEs) [Safety and Tolerability]. (time frame: through study completion, an average of 1 year). 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 15 Apr 2026.