HW071021 Monotherapy in Patients With Advanced Solid Tumors

NCT06882135 | Recruiting Phase 1

• 1 other identifier: RFSO-2024-11
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

  Assessed by CTCAE v5.0

  Up to 2 years

Secondary Outcomes (10)

• Pharmacokinetic Parameter：Maximum Plasma Concentration (Cmax）(Phase 1 only)

  Up to 5 weeks

• Pharmacokinetic Parameter：Area Under the Curve from Time 0 to the Last Quantifiable Data Point (AUC0-t）(Phase 1 only)

  Up to 5 weeks

• Pharmacokinetic Parameter：Area Under the Curve Over a Dosing Interval (AUCss,0-tau）(Phase 1 only)

  Up to 2 years

• Pharmacokinetic Parameter：Trough Concentration (Ctrough）

  Up to 2 years

• Number of patients with Dose-limiting Toxicities (DLTs) during the DLT assessment period(Phase 1 only)

  Up to 5 weeks

Study Arms (2)

HW071021 Dose Escalation

EXPERIMENTAL

Six dose levels were pre-specified, with a starting dose of 50 mg/day; subsequent levels may be adjusted based on pharmacokinetic (PK) and safety data.

Drug: HW071021 Tablets

HW071021 Dose Expansion

EXPERIMENTAL

Based on the results of the dose escalation phase, 1-2 dose levels were selected.

Drug: HW071021 Tablets

Interventions

HW071021 Tablets DRUG

Administered orally at pre-specified doses once or twice daily.

HW071021 Dose Escalation; HW071021 Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wuhan Humanwell Innovative Drug Research and Development Center Limited Company: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Study Officials

• Li Zhang, Doctor

  Sun Yat-Sen University Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Medical Affairs Department

CONTACT

+86-27-87171183; medicalaffairs@renfu.com.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: March 18, 2025
• Study Start: May 28, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)