HWS116 Monotherapy in Patients With Advanced Solid Tumors

A Phase I, Single-Arm, Open-Label, Dose-Escalation and Expansion Study of HWS116 Injection in Advanced Solid Tumors

This is a Phase I open-label study that will evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of HWS116 monotherapy in patients with advanced solid tumors.

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Drug: HWS116 Injection

Detailed Description

This trial is an open-label, dose-escalation/expansion first-in-human study of HWS116, divided into two parts:

Part 1 (Dose Escalation): This part plans to enroll patients with advanced solid tumors who have no standard treatment, have failed standard treatment, or are ineligible for standard treatment. Patients will receive monotherapy with HWS116 at pre-specified escalating doses. The objectives are to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of HWS116 in patients.

Part 2 (Dose Expansion): This part intends to enroll patients with advanced solid tumors who have no standard treatment, have failed standard treatment, or are ineligible for standard treatment. Patients will receive continuous administration of HWS116 to provide additional clinical data for evaluating preliminary efficacy and determining the Phase 2 recommended dose (P2RD) and potential indications.

• Study Type: Interventional
• Enrollment (Estimated): 56
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Ruihua Xu, Doctor; Phone Number: 86-20-87343468; Email: xurh@sysucc.org.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Sun Yat-sen University
      • Principal Investigator: Ruihua Xu, Doctor
      • Contact: Ruihua Xu, Doctor; Phone Number: 86-20-87343468; Email: xurh@sysucc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Aged ≥18 years at the time of signing the Informed Consent Form (ICF);
• Patients with recurrent or metastatic solid tumors confirmed by histology or cytology, who have progressed or developed intolerance after System Organ Class (SOC), or have no SOC available, or are not suitable for SOC, including but not limited to colorectal cancer, gastric cancer, esophageal cancer, pancreatic cancer, and cholangiocarcinoma;
• According to the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1, there is at least one evaluable lesion or one measurable target lesion；
• Life expectancy ≥ 12 weeks;
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score is 0 or 1；
• Participant must have adequate main organ function.
• 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 Criteria:

• Known allergy to the investigational product, drugs of the same class, or any excipients;
• Have previously received any Fibroblast Growth Factor- Fibroblast Growth Factor Receptor (FGF-FGFR) pathway inhibitor;
• For previous anti-tumor therapies (including investigational products/treatments): those who have received chemotherapy, small molecule targeted therapy, endocrine therapy, herbal medicine therapy/physiotherapy within 14 days prior to the first dose or within at least 5 half-lives of the corresponding drug, whichever is longer; or those who have undergone surgery (excluding diagnostic procedures such as needle biopsy), radiotherapy (palliative radiation for non-target lesions is within 14 days prior to the first dose), biotherapy, immunotherapy, or other anti-tumor therapies within 28 days prior to the first dose or within at least 5 half-lives of the corresponding drug, whichever is longer;
• Have undergone major surgery within 28 days prior to the first dose;
• Have Grade ≥ 2 toxicity caused by previous anti-tumor treatment prior to the first dose, except for those deemed by investigators to pose no safety risk, such as alopecia, pigmentation, or specific laboratory abnormalities;
• Have corneal defects, or other known corneal abnormalities that may increase the risk of corneal ulcer . undergone corneal surgery within 6 months prior to the first dose;
• Have severe cardiovascular or cerebrovascular diseases；
• Have a history of clinically significant corrected QT Interval (QTc) prolongation, or QTc interval > 480 msec at screening;
• Metastases to central nervous system with clinical symptoms or active progression;
• Have tested positive for hepatitis B surface antigen (HBsAg) (except for patients with hepatocellular carcinoma) with hepatitis B virus deoxyribonucleic acid (HBV DNA) > 1000 IU/mL, or positive for hepatitis C virus (HCV) antibody with HCV ribonucleic acid (RNA) positive, or positive for human immunodeficiency virus (HIV) antibody, or have active syphilis;
• Have autoimmune diseases, immunodeficiencies, a history of organ transplantation, or are planning to undergo organ transplantation;
• 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；
• Have acute inflammation or clinically significant active infections;
• Have a history of alcohol abuse or drug abuse;
• Pregnant or lactating women or women who are preparing for pregnancy or lactation during the study period;
• Any other condition that, at the discretion of investigators, renders the participant unsuitable for enrollment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: HWS116 Injection; Dose Escalation: Intravenous infusion once of HWS116 for injection every two weeks, with a starting dose of 1.5 mg/kg; subsequent levels may be adjusted based on pharmacokinetic (PK) and safety data. Dose Expansion: Based on the results of the dose escalation phase, 1-3 dose levels or specific indication were selected.	Drug: HWS116 Injection; Administered intravenous infusion at pre-specified doses every two weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of Treatment-Emergent Adverse Events (Part 1 Only)	Up to 2 years
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (Part 2 Only)	Up to 2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetic Parameter: Maximum Plasma Concentration (Cmax)	Up to 2 years
Preliminary Efficacy: Objective Response Rate (ORR) (Part 1 Only)	Up to 2 years
Preliminary Efficacy: Progression-Free Survival (PFS)	Up to 2 years
Pharmacokinetic Parameter: Area under the Concentration-Time Curve (AUC0-t)	Up to 2 years
Pharmacokinetic Parameter: Area under the Concentration-Time Curve (AUC0-∞)	Up to 2 years
Pharmacokinetic Parameter: Steady-State Peak Concentration (Cmax,ss)	Up to 2 years
Pharmacokinetic Parameter: Steady-State trough Concentration (Cmin,ss)	Up to 2 years
Pharmacokinetic Parameter: Steady-State Area under the Curve (AUCss)	Up to 2 years
Number of Patients with Dose-limiting Toxicities (DLTs) during the DLT Assessment Period (Part 1 Only)	Up to 2 years
Maximum Tolerated Dose (MTD) Based on Number of DLTs (Part 1 Only)	Up to 2 years
Phase II Recommended Dose	Up to 2 years
Preliminary Efficacy: Overall Survival (OS)	Up to 2 years
Immunogenicity of HWS116 Injection Monotherapy in the Treatment of Advanced Solid Tumors: Anti-Drug Antibody (ADA)	Up to 2 years

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): February 28, 2028

Study Registration Dates

• First Submitted: February 9, 2026
• First Submitted That Met QC Criteria: February 13, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: RFFG-2025-07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The decision not to share IPD is based on ethical and legal considerations to protect participant privacy and confidentiality. The trial involves sensitive data that, if de-identified, could still pose risks to participants in accordance with the Regulations of the People's Republic of China on the Administration of Human Genetic Resources. Additionally, the study protocol and informed consent form did not explicitly state that data would be shared beyond the trial team.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No