HWS116 Monotherapy in Patients With Advanced Solid Tumors

NCT07413328 | Recruiting Phase 1

• 1 other identifier: RFFG-2025-07
• Study Type: interventional
• Target: 56
• 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 HWS116 monotherapy in patients with advanced solid tumors.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (13)

• Pharmacokinetic Parameter: Maximum Plasma Concentration (Cmax)

  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

Study Arms (1)

Experimental: HWS116 Injection

EXPERIMENTAL

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

Interventions

HWS116 Injection DRUG

Administered intravenous infusion at pre-specified doses every two weeks.

Experimental: HWS116 Injection

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

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

Study Sites (1)

Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

RECRUITING

Central Study Contacts

Ruihua Xu, Doctor

CONTACT

86-20-87343468; xurh@sysucc.org.cn

Study Design

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

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: February 17, 2026
• Study Start: April 7, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): February 28, 2028
• Last Updated: April 28, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)