Home › Trials › NCT06799637

Testing XNW28012 in patients with advanced solid tumors who have not responded to standard treatments

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

PHASE1; PHASE2 · Evopoint Biosciences Inc. · NCT06799637

This study is testing a new treatment called XNW28012 in patients with advanced solid tumors who haven't had success with regular cancer therapies to see if it can help them.

Quick facts

PhasePHASE1; PHASE2
Study typeInterventional
Enrollment350 (estimated)
Ages18 Years and up
SexAll
SponsorEvopoint Biosciences Inc. (industry)
Drugs / interventionschemotherapy, immunotherapy
Locations24 sites (Hefei, Anhui and 23 other locations)
Trial IDNCT06799637 on ClinicalTrials.gov

What this trial studies

This is an open-label, multicenter clinical trial evaluating the safety and efficacy of XNW28012 in patients with advanced solid tumors who have failed standard anti-cancer therapies. The study is divided into two parts: a dose escalation phase to determine the optimal dosage and a dose expansion phase focusing on specific types of cancers such as ovarian, cervical, and pancreatic cancers. Participants will be closely monitored for treatment response and side effects throughout the trial.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with advanced solid tumors who have not responded to or are intolerant of standard therapies.

Not a fit: Patients with early-stage tumors or those who have not yet undergone standard treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors who have limited treatment choices.

How similar studies have performed: Other studies have shown promise with similar investigational therapies in advanced solid tumors, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. 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.
2. 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.
3. Age ≥ 18 years old at the time of consent.
4. Subjects must have at least 1 measurable lesion as defined per RECIST version 1.1 (for dose expansion part only).
5. 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.
6. Subjects must have adequate organ function within 7 days prior to the first study drug administration, as indicated by the flaboratory values:
7. Life expectancy of at least 12 weeks.
8. 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.
9. 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.
10. Subjects are able to provide written informed consent, understand and are willing to comply with the requirements of the study.

Exclusion Criteria:

1. A history of severe infusion reactions to other monoclonal antibodies/antibody drug conjugates (ADCs) or allergic reactions to any components of XNW28012.
2. 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.
3. 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 .
4. 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.
5. 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.
6. 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).
7. Any history of intracerebral arteriovenous malformation, cerebral aneurysm, or stroke (transient ischemic attack) ≤ 3 months prior to screening is allowed if stable.
8. Any of the hematological risk factors:
9. 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.

Where this trial is running

Hefei, Anhui and 23 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Advanced Solid Tumors, Pancreatic Carcinoma, Ovarian Cancer, Cervical Cancers, XNW28012

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.