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

Status: Recruiting
Location: See all (24) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Affiliated Hospital of Hebei University
RECRUITING
Baoding
Beijing Friendship Hospital, Capital Medical University
RECRUITING
Beijing
Peking Union Medical College Hospital
RECRUITING
Beijing
Affiliated Hospital of Binzhou Medical College
RECRUITING
Binzhou
Hunan Cancer Hospital
RECRUITING
Changsha
The Second Xiangya Hospital Of Central South University
RECRUITING
Changsha
Sichuan Provincial People's Hospital
RECRUITING
Chengdu
West China Hospital of Sichuan University
RECRUITING
Chengdu
Chongqing University Cancer Hospital
RECRUITING
Chongqing
Fujian Provincial Cancer Hospital
RECRUITING
Fuzhou
First Affiliated Hospital of Gannan Medical College
RECRUITING
Ganzhou
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
RECRUITING
Guangzhou
Affiliated Hospital of Guizhou Medical University
RECRUITING
Guiyang
The First Affiliated Hospital of Zhejiang University School of Medicine
RECRUITING
Hangzhou
Affiliated Cancer Hospital of Harbin Medical University
RECRUITING
Harbin
Second Affiliated Hospital of Anhui Medical University
RECRUITING
Hefei
The First Affiliated Hospital of University of Science and Technology of China
RECRUITING
Hefei
Jinan Central Hospital
RECRUITING
Jinan
Yunnan Cancer Hospital
RECRUITING
Kunming
Linyi Cancer Hospital
RECRUITING
Linyi
First Affiliated Hospital of Henan University of Science and Technology
RECRUITING
Luoyang
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Hubei Cancer Hospital
RECRUITING
Wuhan
First Affiliated Hospital of Kunming Medical University
RECRUITING
Yunnan
Contact Information
Primary
Yingjie zhao Yingjie Zhao
yingjie.zhao@evopointbio.com
+86 15553136593
Backup
Ziwen Ke
ziwen.ke@evopointbio.com
+86 15172466243
Time Frame
Start Date: 2023-12-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 200
Treatments
Other: Bayesian Optimal Interval (BOIN) method will be used for the dose escalation part.
Based 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.
Related Therapeutic Areas
Sponsors
Leads: Evopoint Biosciences Inc.

This content was sourced from clinicaltrials.gov