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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Second Affiliated Hospital of Anhui Medical University
  Hefei, Anhui, China Recruiting
• The First Affiliated Hospital of University of Science and Technology of China
  Hefei, Anhui, China Recruiting
• Beijing Friendship Hospital, Capital Medical University
  Beijing, Beijing Municipality, China Recruiting
• Peking Union Medical College Hospital
  Beijing, Beijing Municipality, China Recruiting
• Chongqing University Cancer Hospital
  Chongqing, Chongqing Municipality, China Recruiting
• Fujian Provincial Cancer Hospital
  Fuzhou, Fujian, China Recruiting

Study contacts

• Study coordinator: Yingjie zhao Yingjie Zhao
• Email: yingjie.zhao@evopointbio.com
• Phone: +86 15553136593

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• CG-7321: a first-in-human test in advanced solid tumors

  We’re testing CG-7321 alone and with fulvestrant to see if it’s safe and tolerable in adults with advanced solid tumors.

  Recruiting at 4 sites Phase 1 Chengdu Cynogen Bio-pharmaceutical Tech. Co., Ltd. · Fuzhou, Fujian and 3 other locations · NCT07923214

• ABBV-253 in adults with advanced solid tumors

  This study tests ABBV-253 to see if it is safe, how it affects the cancer, and how the drug moves in the body for adults with advanced solid tumors.

  Recruiting at 3 sites Phase 1 AbbVie · Grand Rapids, Michigan and 2 other locations · NCT07807956

• SYN818 plus olaparib for advanced or metastatic BRCA‑mutant or HRD solid tumors

  This study tests whether combining SYN818 with olaparib is safe and helps control advanced or metastatic solid tumors in adults whose cancers have BRCA mutations or homologous recombination repair defects.

  Recruiting at 2 sites Phase 1 Hangzhou SynRx Therapeutics Biomedical Technology Co., Ltd · Shanghai, Shanghai Municipality and 1 other locations · NCT07156253

• IDOV-Immune for advanced solid tumors

  This trial will try a single IV infusion of an engineered oncolytic vaccinia virus called IDOV-Immune in adults with advanced solid tumors that no longer respond to standard treatments.

  Recruiting at 5 sites Phase 1 ViroMissile, Inc. · St Louis, Missouri and 4 other locations · NCT06910657

• Testing PHST001 for advanced solid tumors

  This study is testing a new treatment called PHST001 to see if it is safe and effective for people with advanced solid tumors that haven't responded to other therapies.

  Recruiting at 20 sites Phase 1 Pheast Therapeutics · Beverly Hills, California and 19 other locations · NCT06840886

• Testing ATX-295 for advanced solid tumors and ovarian cancer

  This study is testing a new oral medication called ATX-295 to see if it is safe and effective for people with advanced solid tumors, including ovarian cancer.

  Recruiting at 11 sites Phase 1/2 Accent Therapeutics · Aurora, Colorado and 10 other locations · NCT06799065

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.