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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
Led by Evopoint Biosciences Inc. · Updated on 2026-04-15
350
Participants Needed
24
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating XNW28012 in adults with advanced solid tumors who have not responded to or cannot tolerate standard anti-tumor treatments. This phase 1, first-in-human study is open-label and multicenter, aiming to assess the safety, tolerability, pharmacokinetics, and early signs of anti-tumor activity of XNW28012. The study includes two parts: dose escalation and dose expansion, focusing on multiple solid tumor types such as ovarian, cervical, pancreatic, and colorectal cancers. Participants will receive XNW28012 intravenously every three weeks at increasing doses determined by a Bayesian Optimal Interval method, starting from 0.6 mg/kg up to 7.5 mg/kg during the dose escalation phase. Treatment continues until intolerable side effects, disease progression without benefit, or withdrawal of consent. The first treatment cycle is carefully monitored for dose-limiting toxicities to guide safe dosing. The subsequent dose expansion part involves treating patients at the recommended dose identified from the escalation phase. Throughout the study, participants will undergo regular safety assessments, including monitoring treatment-related adverse events, organ function tests, and tumor response evaluations. Imaging and clinical evaluations for tumor progression will occur at scheduled intervals up to one year. Researchers will also measure drug levels, immune response to the drug, and tumor control outcomes. Participants are followed closely to evaluate treatment effects, side effects, and overall health status during and after therapy.
CONDITIONS
Brief Title
Study of XNW28012 in Subjects With Advanced Solid Tumors Who Failed Standard Treatments
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older at the time of consent
- For dose escalation: confirmed advanced or metastatic solid tumors with failed or intolerant standard anti-cancer therapies
- For dose expansion: diagnosed progressive, locally advanced, or metastatic ovarian, cervical, pancreatic, or colorectal cancer with failed standard therapies
- At least one measurable lesion (dose expansion part only)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; ECOG 2 allowed if due to disease progression with medical monitor approval
- Adequate organ function within 7 days before first study drug administration
- Life expectancy of at least 12 weeks
- Negative pregnancy test for females of childbearing potential within 7 days before first dose
- Willingness to use effective contraception during the study and for 6 months after last dose if not sterile
- Ability to provide informed consent and comply with study requirements
You will not qualify if you...
- History of severe infusion reactions or allergies to monoclonal antibodies or components of XNW28012
- Any anti-tumor therapy within 28 days prior to first dose
- Any active malignancy other than the targeted cancers or treated local recurrence
- Receipt of live vaccine within 4 weeks prior to first dose (except inactivated influenza vaccine)
- Use of granulocyte colony stimulating factors within specific timeframes before screening
- Unresolved toxicities from prior anti-cancer therapy above CTCAE grade 1 except non-safety-risk AEs
- Recent intracerebral arteriovenous malformation, cerebral aneurysm, or stroke unless stable
- Hematological risk factors as defined in the protocol
- Unwillingness or inability 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 (TEN) or Stevens Johnson Syndrome
- Major surgery within 28 days prior to first dose except minimally invasive procedures such as PICC line insertion
- Other criteria as detailed in protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 21-day cycles until intolerant toxicity, disease progression, or withdrawal
Participants receive the study drug XNW28012 every 3 weeks until intolerant toxicity, disease progression without clinical benefit, or withdrawal of consent.
Visits every 3 weeks for dosing and safety assessments
Duration - Up to 1 year after treatment initiation
Participants are monitored for safety, tolerability, pharmacokinetics, and antitumor efficacy through assessments after treatment completion.
Efficacy assessments every 6 weeks for 24 weeks, then every 12 weeks until disease progression or up to 1 year
Trial Site Locations
Total: 24 locations
1
Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
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2
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, China
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3
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
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4
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
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5
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
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6
Fujian Provincial Cancer Hospital
Fuzhou, Fujian, China
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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
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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
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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
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Research Team
Y
Yingjie zhao Yingjie Zhao
Z
Ziwen Ke
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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