New hope for advanced cancers: experimental drug XNW28012 enters human trials
NCT ID NCT06799637
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a new drug called XNW28012 in people with advanced solid tumors (pancreatic, ovarian, cervical, or colorectal cancers) that have stopped responding to standard treatments. The trial has two parts: first, finding a safe dose, then expanding to see if the drug shrinks tumors. About 350 participants will receive the drug every three weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- XNW28012
- What this could lead to
- If successful, this could point toward a new treatment option for advanced solid tumors that have not responded to standard therapies.
- What could go wrong
- This is an early phase 1/2 trial with a small number of participants, so the drug may not prove effective or safe enough for wider use. Side effects are unknown and will be closely monitored.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 350 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2023
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
24 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Affiliated Cancer Hospital of Harbin Medical University
RECRUITINGHarbin, Heilongjiang, China
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Affiliated Hospital of Binzhou Medical College
RECRUITINGBinzhou, Shandong, China
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Affiliated Hospital of Guizhou Medical University
RECRUITINGGuiyang, Guizhou, China
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Affiliated Hospital of Hebei University
RECRUITINGBaoding, Hebei, China
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Beijing Friendship Hospital, Capital Medical University
RECRUITINGBeijing, Beijing Municipality, China
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Chongqing University Cancer Hospital
RECRUITINGChongqing, Chongqing Municipality, China
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First Affiliated Hospital of Gannan Medical College
RECRUITINGGanzhou, Jiangxi, China
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First Affiliated Hospital of Henan University of Science and Technology
RECRUITINGLuoyang, Henan, China
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First Affiliated Hospital of Kunming Medical University
RECRUITINGYunnan, Kunming, China
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Fudan University Shanghai Cancer Center
RECRUITINGShanghai, Shanghai Municipality, China
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Fujian Provincial Cancer Hospital
RECRUITINGFuzhou, Fujian, China
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Hubei Cancer Hospital
RECRUITINGWuhan, Hubei, China
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Hunan Cancer Hospital
RECRUITINGChangsha, Hunan, China
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Jinan Central Hospital
RECRUITINGJinan, Shandong, China
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Linyi Cancer Hospital
RECRUITINGLinyi, Shandong, China
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Peking Union Medical College Hospital
RECRUITINGBeijing, Beijing Municipality, China
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Second Affiliated Hospital of Anhui Medical University
RECRUITINGHefei, Anhui, China
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Sichuan Provincial People's Hospital
RECRUITINGChengdu, Sichuan, China
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Sun Yat-sen Memorial Hospital, Sun Yat-sen University
RECRUITINGGuangzhou, Guangdong, China
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The First Affiliated Hospital of University of Science and Technology of China
RECRUITINGHefei, Anhui, China
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The First Affiliated Hospital of Zhejiang University School of Medicine
RECRUITINGHangzhou, Zhejiang, China
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The Second Xiangya Hospital Of Central South University
RECRUITINGChangsha, Hunan, China
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West China Hospital of Sichuan University
RECRUITINGChengdu, Sichuan, China
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Yunnan Cancer Hospital
RECRUITINGKunming, Yunnan, China
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