HW071021 monotherapy for advanced solid tumors

A Phase I Open-Label, Dose-Escalation and Dose-Expansion Trial Evaluating Safety, Pharmacokinetics, and Efficacy of HW071021 in Patients With Advanced Solid Tumors

This study will try an oral drug called HW071021 by itself to see if it is safe and helps adults with advanced solid tumors who have no standard treatment options.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 76 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Wuhan Humanwell Innovative Drug Research and Development Center Limited Company (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06882135 on ClinicalTrials.gov

What this trial studies

This first-in-human, open-label Phase 1 trial uses a dose-escalation and expansion design to test oral HW071021 as a single agent in adults with advanced solid tumors. The dose-escalation phase enrolls patients who have failed or lack standard therapies to determine safety, tolerability, and pharmacokinetics, with selected subjects undergoing QT/QTc cardiac monitoring. The expansion phase will enroll tumor-specific cohorts chosen based on escalation results to gather additional safety and preliminary efficacy data and to help define a recommended Phase 2 dose. Patients receive continuous oral dosing at predefined dose levels and are followed for adverse events and radiographic response per RECIST 1.1.

Who should consider this trial

Good fit: Adults (≥18 years) with histologically or cytologically confirmed recurrent or metastatic solid tumors (for example, non-small cell lung cancer, colorectal, pancreatic, cholangiocarcinoma) who have failed or have no available standard treatments, have ECOG performance status 0–1, adequate organ function, life expectancy ≥12 weeks, and at least one measurable lesion are the intended candidates.

Not a fit: Patients who have effective standard treatment options, ECOG performance status ≥2, inadequate organ function, life expectancy under 12 weeks, or who are pregnant or breastfeeding are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, HW071021 could become a new oral treatment option that is safe and may help control tumor growth for some patients with advanced solid cancers.

How similar studies have performed: This is a first-in-human compound, so although dose-escalation monotherapy designs have sometimes shown benefit for other agents, HW071021's safety and clinical activity in humans remain unproven.

Eligibility criteria

Inclusion Criteria:

1. Age of 18 years or older, applicable to both males and females.
2. 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.
3. No standard treatment is accessible, standard treatment has failed, or the patient is not suitable for standard treatment.
4. The expected survival time is ≥ 12 weeks.
5. Participant must have adequate main organ function.
6. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score is 0 or 1.
7. According to the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1, there is at least one measurable target lesion.
8. 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.
9. 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 Criteria:

1. Known allergy to the investigational drug, drugs with the same mechanism of action or excipients.
2. Prior treatment with drugs targeting the same molecular target.
3. 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).
4. 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).
5. 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.
6. Undergoing major surgery within 28 days before the first dose.
7. 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).
8. Severe cardiovascular or cerebrovascular diseases.
9. History of clinically significant QTc interval prolongation, or QTc interval \> 470 ms in females and \> 450 ms in males at screening.
10. Uncontrolled/clinically symptomatic central nervous system metastases.
11. 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).
12. Diagnosis of autoimmune disease, immunodeficiency disorder, history of organ transplantation, or planned organ transplantation.
13. Inability to swallow oral formulations and/or gastrointestinal disorders that may interfere with drug absorption.
14. 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.
15. Any significant clinical or laboratory abnormalities affecting safety assessment, as determined by the investigator.
16. 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.
17. History of alcohol abuse or substance dependence.
18. Pregnant or lactating females, or females planning to become pregnant or breastfeed during the study.
19. Other conditions deemed unsuitable for enrollment by the investigator.

Where this trial is running

Guangzhou, Guangdong

• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Principal investigator: Li Zhang, Doctor — Sun Yat-Sen University Cancer Center
• Study coordinator: Medical Affairs Department

Conditions Advanced Solid Tumors