RecruitingPhase 1Phase 2NCT06799637

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

Sponsor

Evopoint Biosciences Inc.

Enrollment

350 participants

Start Date

Dec 1, 2023

Study Type

INTERVENTIONAL

Conditions

Ovarian Cancer Pancreatic Carcinoma Advanced Solid Tumors Cervical Cancers

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new investigational drug called XNW28012 in patients with advanced solid tumors that have stopped responding to standard treatments. The dose escalation phase is open to various solid tumors; the expansion phase focuses on ovarian cancer, cervical cancer, pancreatic cancer, and colorectal cancer. **You may be eligible if...** - You are 18 or older - You have a confirmed solid tumor (ovarian, cervical, pancreatic, or colorectal cancer in the expansion phase) that is advanced or metastatic - You have already tried and failed established standard cancer treatments for your tumor type - Your cancer has at least one measurable lesion on imaging (for expansion cohort) - Your organ function meets the required thresholds **You may NOT be eligible if...** - You have not yet tried available standard therapies - You have poor organ function or very low blood counts - You are pregnant or breastfeeding - You have significant uncontrolled medical conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGXNW28012

Eligible subjects will receive XNW28012 every 3 weeks (Q3W) until intolerant toxicity, progression of disease with no clinical benefit, or withdrawal of informed consent.

Locations(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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06799637

Related Trials

The Vanguard Study: Testing a New Way to Screen for Cancer

NCT0699589837 locations

DESTINY-PANTUMOUR04

NCT0712400017 locations

A Clinical Trial of Sac-TMT in People With Non-HRD Positive Advanced Ovarian Cancer (MK-2870-021)

NCT0731855828 locations

A Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) Maintenance Treatment Versus Standard of Care in Participants With Platinum-sensitive Recurrent Ovarian Cancer (MK-2870-022/TroFuse-022/ENGOT-ov84/GOG-3103)

NCT06824467164 locations

Observational, Bi-directional (Prospective and Retrospective) Study for Patients With Newly Diagnosed Ovarian Cancer Stages IA to IVB, or Persistent or Recurrent Disease From January 2021; Irrespective of Histology

NCT071674331 location