Actively Recruiting
HW071021 Monotherapy in Patients With Advanced Solid Tumors
Led by Wuhan Humanwell Innovative Drug Research and Development Center Limited Company · Updated on 2025-12-29
76
Participants Needed
1
Research Sites
91 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
HW071021 Monotherapy in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age of 18 years or older, applicable to both males and females.
- Histologically and/or cytologically confirmed recurrent and/or metastatic advanced solid tumors, including non-small cell lung cancer, colorectal cancer, pancreatic cancer, cholangiocarcinoma, or other cancers deemed potentially beneficial.
- No accessible standard treatment, failed standard treatment, or ineligibility for standard treatment.
- Expected survival time of at least 12 weeks.
- Adequate major organ function.
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
- At least one measurable target lesion according to RECIST 1.1.
- Use of two medically approved effective contraceptive methods during the study and for 6 months after last dose if capable of having children; negative pregnancy test for women of childbearing age within 7 days before dosing.
- Ability to understand the study, voluntarily sign informed consent, and comply with study procedures and follow-up.
You will not qualify if you...
- Known allergy to HW071021, drugs with the same mechanism, or excipients.
- Prior treatment with drugs targeting the same molecular target.
- Use of other investigational drugs within 28 days before first dose or at least 5 half-lives of those drugs.
- 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 first dose or at least 5 half-lives.
- Use of drugs interfering with trial safety within 2 weeks before dosing or planned use during study, including strong metabolic enzyme inhibitors/inducers or narrow therapeutic index substrates.
- Undergoing major surgery within 28 days before first dose.
- Grade 2 or higher toxicity from prior anti-cancer treatment except non-safety-critical toxicities.
- Severe cardiovascular or cerebrovascular diseases.
- History of significant QTc interval prolongation or QTc > 470 ms in females and > 450 ms in males at screening.
- Uncontrolled or symptomatic central nervous system metastases.
- Positive for hepatitis B surface antigen with high HBV DNA (except hepatocellular carcinoma), positive hepatitis C antibody with RNA positive, positive HIV antibody, or active syphilis.
- Diagnosis of autoimmune disease, immunodeficiency, history or planned organ transplantation.
- Inability to swallow oral drugs or gastrointestinal disorders affecting absorption.
- Severe uncontrolled clinical issues or psychiatric conditions unsuitable for participation.
- Significant clinical or laboratory abnormalities affecting safety.
- Severe pulmonary diseases including embolism, interstitial lung disease, active infections.
- History of alcohol abuse or substance dependence.
- Pregnant, lactating, or planning pregnancy or breastfeeding during study.
- Other conditions deemed unsuitable by investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
M
Medical Affairs Department
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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