Study of XNW28012 in Subjects With Advanced Solid Tumors Who Failed 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
1 other identifier
interventional
350
1 country
24
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Dec 2023
Typical duration for phase_1
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2023
CompletedFirst Submitted
Initial submission to the registry
December 25, 2024
CompletedFirst Posted
Study publicly available on registry
January 29, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
April 15, 2026
April 1, 2026
3.1 years
December 25, 2024
April 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Ph 1: Incidence and severity of treatment-emergent adverse events (AEs) [Safety and Tolerability].
Incidence and severity of adverse events that are graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
through study completion, an average of 1 year
Ph 2: To evaluate the antitumor efficacy of XNW28012 at the recommended Part 2 dose.
ORR per RECIST1.1 assessed by Investigators.
through study completion, an average of 1 year
Secondary Outcomes (9)
Ph 1:Maximum tolerated dose (MTD) and/or the recommended Part 2 dose.
The first 21-day cycle of therapy
Ph 1/II: Maximum (peak) observed concentration (Cmax) of XNW28012.
through study completion, an average of 1 year
Ph 1/II: Maximum (peak) observed concentration (Cmax) of total antibody of XNW28012..
through study completion, an average of 1 year
Ph 1/II: Maximum (peak) observed concentration (Cmax) of YL0010014
through study completion, an average of 1 year
Ph 1/II: Anti-drug antibody (ADA)
through study completion, an average of 1 year
- +4 more secondary outcomes
Other Outcomes (1)
Ph 1/2: Tissue factor expression
At screening
Study Arms (1)
Bayesian Optimal Interval (BOIN) method will be used for the dose escalation part.
OTHERBased on the toxicology data from preclinical studies, the Bayesian Optimal Interval (BOIN) method will be used for the dose escalation part with preset doses at 0.6 mg/kg, 1.2 mg/kg, 2.4 mg/kg, 3.6 mg/kg, 4.8 mg/kg, 6.0 mg/kg, and 7.5 mg/kg. Eligible subjects will receive XNW28012 every 3 weeks (Q3W) until intolerant toxicity, progression of disease with no clinical benefit, or withdrawal of informed consent. The first treatment cycle will be the dose limiting toxicity (DLT) assessment period. The safety, tolerability, and occurrence of DLTs will be assessed during the DLT period. The proposed dose escalation plan is shown below.
Interventions
Eligible subjects will receive XNW28012 every 3 weeks (Q3W) until intolerant toxicity, progression of disease with no clinical benefit, or withdrawal of informed consent.
Eligibility Criteria
You may qualify if:
- 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.
- 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.
- Age ≥ 18 years old at the time of consent.
- Subjects must have at least 1 measurable lesion as defined per RECIST version 1.1 (for dose expansion part only).
- 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.
- Subjects must have adequate organ function within 7 days prior to the first study drug administration, as indicated by the flaboratory values:
- Life expectancy of at least 12 weeks.
- 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.
- 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.
- Subjects are able to provide written informed consent, understand and are willing to comply with the requirements of the study.
You may not qualify if:
- A history of severe infusion reactions to other monoclonal antibodies/antibody drug conjugates (ADCs) or allergic reactions to any components of XNW28012.
- 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.
- 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 .
- 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.
- 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.
- 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).
- Any history of intracerebral arteriovenous malformation, cerebral aneurysm, or stroke (transient ischemic attack) ≤ 3 months prior to screening is allowed if stable.
- Any of the hematological risk factors:
- Subjects who are unwilling or unable to provide tumor tissue samples that meet the requirements for tissue factor (TF) expression testing.
- \. Clinically significant cardiovascular/cerebrovascular conditions. 12. Active ocular surface disease at screening, or subjects with any prior episode of cicatricial conjunctivitis.
- \. 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
Fujian Provincial Cancer Hospital
Fuzhou, Fujian, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
Affiliated Hospital of Hebei University
Baoding, Hebei, China
Affiliated Cancer Hospital of Harbin Medical University
Harbin, Heilongjiang, China
First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
Hubei Cancer Hospital
Wuhan, Hubei, China
Hunan Cancer Hospital
Changsha, Hunan, China
The Second Xiangya Hospital Of Central South University
Changsha, Hunan, China
First Affiliated Hospital of Gannan Medical College
Ganzhou, Jiangxi, China
First Affiliated Hospital of Kunming Medical University
Yunnan, Kunming, China
Affiliated Hospital of Binzhou Medical College
Binzhou, Shandong, China
Jinan Central Hospital
Jinan, Shandong, China
Linyi Cancer Hospital
Linyi, Shandong, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Yunnan Cancer Hospital
Kunming, Yunnan, China
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 25, 2024
First Posted
January 29, 2025
Study Start
December 1, 2023
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
April 15, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share