Actively Recruiting
Study of XNW28012 in Subjects With Advanced Solid Tumors Who Failed Standard Treatments
Led by Evopoint Biosciences Inc. · Updated on 2026-04-15
350
Participants Needed
24
Research Sites
160 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of XNW28012 in Subjects With Advanced Solid Tumors Who Failed Standard Treatments
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects with histologically or cytologically confirmed advanced and/or metastatic solid tumors who have failed standard anti-cancer therapies or are intolerant to such therapies (dose escalation part).
- Subjects with progressive, locally advanced, and/or metastatic ovarian, cervical, pancreatic, or colorectal cancer who have failed specified anti-cancer therapies (dose expansion part).
- Age 18 years or older at consent.
- At least one measurable lesion per RECIST version 1.1 (dose expansion part only).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; ECOG 2 allowed if due to disease progression and approved by medical monitor.
- Adequate organ function within 7 days prior to first study drug administration.
- Life expectancy of at least 12 weeks.
- Negative pregnancy test within 7 days prior to first dose for females of childbearing potential.
- Willingness to use effective contraception during the study and for 6 months after last dose unless partner is sterilized.
- Ability to provide written informed consent and comply with study requirements.
You will not qualify if you...
- History of severe infusion reactions to monoclonal antibodies or allergic reactions to components of XNW28012.
- Receipt of any anti-tumor therapy within 28 days prior to first dose, including small molecules, immunotherapy, chemotherapy, monoclonal antibodies, or experimental drugs.
- Presence of any active malignancy other than the study cancers or treated locally recurring cancer.
- Receipt of live vaccines within 4 weeks prior to first dose; intranasal influenza vaccines not allowed if live attenuated.
- Use of granulocyte colony stimulating factors within specified timeframes before screening.
- Unresolved toxicities from prior anti-cancer therapy above grade 1 except alopecia.
- History of intracerebral arteriovenous malformation, cerebral aneurysm, or stroke within 3 months prior to screening unless stable.
- Hematological risk factors as defined in the protocol.
- Inability or unwillingness to provide tumor tissue for tissue factor expression testing.
- Clinically significant cardiovascular or cerebrovascular conditions.
- Active ocular surface disease or history of cicatricial conjunctivitis.
- History of Toxic Epidermal Necrolysis or Stevens-Johnson Syndrome.
- Major surgery within 28 days prior to first dose except minimally invasive procedures like PICC line insertion.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 24 locations
1
Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Actively Recruiting
2
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, China
Actively Recruiting
3
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Actively Recruiting
4
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
5
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
Actively Recruiting
6
Fujian Provincial Cancer Hospital
Fuzhou, Fujian, China
Actively Recruiting
7
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
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8
Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
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9
Affiliated Hospital of Hebei University
Baoding, Hebei, China
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10
Affiliated Cancer Hospital of Harbin Medical University
Harbin, Heilongjiang, China
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11
First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
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12
Hubei Cancer Hospital
Wuhan, Hubei, China
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13
Hunan Cancer Hospital
Changsha, Hunan, China
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14
The Second Xiangya Hospital Of Central South University
Changsha, Hunan, China
Actively Recruiting
15
First Affiliated Hospital of Gannan Medical College
Ganzhou, Jiangxi, China
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16
First Affiliated Hospital of Kunming Medical University
Yunnan, Kunming, China
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17
Affiliated Hospital of Binzhou Medical College
Binzhou, Shandong, China
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18
Jinan Central Hospital
Jinan, Shandong, China
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19
Linyi Cancer Hospital
Linyi, Shandong, China
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20
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
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21
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
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22
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Actively Recruiting
23
Yunnan Cancer Hospital
Kunming, Yunnan, China
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24
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
Y
Yingjie zhao Yingjie Zhao
CONTACT
Z
Ziwen Ke
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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