HWS116 as a single treatment for advanced solid tumors

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

This Phase 1 trial will try HWS116 as a single treatment in adults with advanced solid tumors to see if it's safe, how the body handles it, and whether it helps tumors.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (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, radiation
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT07413328 on ClinicalTrials.gov

What this trial studies

This is a first-in-human, open-label Phase 1 trial using a dose-escalation then dose-expansion design to study HWS116 monotherapy in patients with advanced solid tumors. In Part 1, small cohorts receive escalating doses to define safety, tolerability, and pharmacokinetics and to identify dose-limiting toxicities. In Part 2, selected doses are given to larger groups to gather additional preliminary efficacy data and to determine a recommended Phase 2 dose. Key outcomes include safety measures, pharmacokinetic profiles, and tumor responses by RECIST 1.1.

Who should consider this trial

Good fit: Adults (≥18) with recurrent or metastatic solid tumors who have progressed on or are ineligible for standard treatments, have at least one measurable lesion, ECOG 0-1, adequate organ function, and a life expectancy of at least 12 weeks.

Not a fit: Patients with good standard therapy options, ECOG performance status ≥2, uncontrolled comorbidities, inadequate organ function, or who cannot comply with study requirements are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, HWS116 could provide a new treatment option that stabilizes or shrinks tumors for some patients with advanced solid cancers.

How similar studies have performed: As a first-in-human trial, HWS116 is novel; other early-phase monotherapy studies for new oncology agents have occasionally shown promising signals but many agents do not advance beyond early testing.

Eligibility criteria

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.

Where this trial is running

Guangzhou, Guangdong

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

Study contacts

• Study coordinator: Ruihua Xu, Doctor

Conditions Advanced Solid Tumors