Status:
RECRUITING
HW071021 Monotherapy in Patients With Advanced Solid Tumors
Lead Sponsor:
Wuhan Humanwell Innovative Drug Research and Development Center Limited Company
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a Phase I open-label study that will evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of HW071021 monotherapy in patients with advanced solid tumors.
Detailed Description
This trial is an open-label, dose-escalation/expansion first-in-human study of HW071021, divided into two phases: Phase 1 (Dose Escalation): This phase plans to enroll patients with advanced solid tu...
Eligibility Criteria
Inclusion
- Age of 18 years or older, applicable to both males and females.
- Patients with histologically and/or cytologically confirmed recurrent and/or metastatic advanced solid tumors, mainly covering non - small cell lung cancer, colorectal cancer, pancreatic cancer, cholangiocarcinoma, and other cancer types that investigators believe may bring benefits. The selection of cancer types in the dose - expansion phase will be decided based on the data from the dose - escalation phase.
- No standard treatment is accessible, standard treatment has failed, or the patient is not suitable for standard treatment.
- The expected survival time is ≥ 12 weeks.
- Participant must have adequate main organ function.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score is 0 or 1.
- According to the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1, there is at least one measurable target lesion.
- Participants who are capable of having children must agree to use two medically approved effective contraceptive methods during the study and for 6 months after the last dose. Women of childbearing age must have a negative serum pregnancy test within 7 days before dosing.
- Have a full understanding of this study, voluntarily sign the informed consent form, and be able to follow the study's operating procedures and requirements for follow - up examinations.
Exclusion
- Known allergy to the investigational drug, drugs with the same mechanism of action or excipients.
- Prior treatment with drugs targeting the same molecular target.
- Use of other investigational drugs within 28 days before the first dose or at least 5 half - lives of the respective drug (whichever is shorter).
- Receipt of surgery, chemotherapy, radiotherapy, targeted therapy, endocrine therapy, biological therapy, immunotherapy, anti - tumor herbal medicine, or other anti - cancer treatments within 28 days before the first dose or at least 5 half - lives of the respective drug (whichever is shorter).
- Use of any drugs likely to interfere with trial safety within 2 weeks before dosing or at least 5 half - lives of the respective drug (whichever is shorter), and planned use during the study, including strong inhibitors/inducers of hepatic metabolic enzymes and P - gp, or substrates of hepatic metabolic enzymes with narrow therapeutic indices.
- Undergoing major surgery within 28 days before the first dose.
- Presence of ≥ Grade 2 toxicity from prior anti - cancer treatment (per Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0), except for toxicities deemed non - safety - critical by the investigator (e.g., alopecia, pigmentation, specific laboratory abnormalities).
- Severe cardiovascular or cerebrovascular diseases.
- History of clinically significant QTc interval prolongation, or QTc interval \> 470 ms in females and \> 450 ms in males at screening.
- Uncontrolled/clinically symptomatic central nervous system metastases.
- Positive for hepatitis B surface antigen (HBsAg) (except for hepatocellular carcinoma patients) with HBV DNA \> 1000 IU/mL; positive for hepatitis C virus (HCV) antibody with HCV RNA positive; positive for human immunodeficiency virus (HIV) antibody; or active syphilis (positive for both TPPA and RPR).
- Diagnosis of autoimmune disease, immunodeficiency disorder, history of organ transplantation, or planned organ transplantation.
- Inability to swallow oral formulations and/or gastrointestinal disorders that may interfere with drug absorption.
- Presence of any severe, uncontrolled clinical issues (e.g., uncontrolled malignant pleural effusion, ascites, pericardial effusion, or unstable psychiatric conditions) deemed unsuitable for study participation by the investigator.
- Any significant clinical or laboratory abnormalities affecting safety assessment, as determined by the investigator.
- Severe pulmonary diseases at screening, including pulmonary embolism, interstitial lung disease, active pulmonary infection, or other active infections deemed unsuitable for study entry by the investigator.
- History of alcohol abuse or substance dependence.
- Pregnant or lactating females, or females planning to become pregnant or breastfeed during the study.
- Other conditions deemed unsuitable for enrollment by the investigator.
Key Trial Info
Start Date :
May 28 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2027
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT06882135
Start Date
May 28 2025
End Date
February 28 2027
Last Update
December 29 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060