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Advanced Solid TumorsPhase 1NCT07413328

HWS116 Monotherapy in Patients With Advanced Solid Tumors

A Phase 1 study testing HWS116 Injection in people with Advanced Solid Tumors, run by Wuhan Humanwell Innovative Drug Research and Development Center Limited Company at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumors
What is being tested?
HWS116 Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 siteChina
Study dates
7 Apr 2026to 28 Feb 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ruihua Xu, Doctor contact

86-20-87343468

xurh@sysucc.org.cn

China1 site, 1 recruiting

  • Sun Yat-sen University

    Guangzhou, Guangdong, 510060

    Ruihua Xu, Doctor, 86-20-87343468, xurh@sysucc.org.cn

    Ruihua Xu, Doctor

    Recruiting

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
HWS116 Injection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HWS116 InjectionDrug

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

Study groups in NCT07413328
Study groupRoleWhat they receive
Experimental: HWS116 InjectionExperimentalDose 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.
Receives: Drug: HWS116 Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Treatment-Emergent Adverse Events (Part 1 Only)

    Measured: Up to 2 years

  2. Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (Part 2 Only)

    Measured: Up to 2 years

Secondary outcomes (13)

  1. Pharmacokinetic Parameter: Maximum Plasma Concentration (Cmax)

    Measured: Up to 2 years

  2. Pharmacokinetic Parameter: Area under the Concentration-Time Curve (AUC0-t)

    Measured: Up to 2 years

  3. Pharmacokinetic Parameter: Area under the Concentration-Time Curve (AUC0-∞)

    Measured: Up to 2 years

  4. Pharmacokinetic Parameter: Steady-State Peak Concentration (Cmax,ss)

    Measured: Up to 2 years

  5. Pharmacokinetic Parameter: Steady-State trough Concentration (Cmin,ss)

    Measured: Up to 2 years

  6. Pharmacokinetic Parameter: Steady-State Area under the Curve (AUCss)

    Measured: Up to 2 years

  7. Number of Patients with Dose-limiting Toxicities (DLTs) during the DLT Assessment Period (Part 1 Only)

    Measured: Up to 2 years

  8. Maximum Tolerated Dose (MTD) Based on Number of DLTs (Part 1 Only)

    Measured: Up to 2 years

  9. Phase II Recommended Dose

    Measured: Up to 2 years

  10. Preliminary Efficacy: Objective Response Rate (ORR) (Part 1 Only)

    Measured: Up to 2 years

  11. Preliminary Efficacy: Progression-Free Survival (PFS)

    Measured: Up to 2 years

  12. Preliminary Efficacy: Overall Survival (OS)

    Measured: Up to 2 years

  13. Immunogenicity of HWS116 Injection Monotherapy in the Treatment of Advanced Solid Tumors: Anti-Drug Antibody (ADA)

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2026
  2. Study start7 Apr 2026
  3. Primary completion31 Aug 2027 (estimated)
  4. Study completion28 Feb 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
56 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07413328
Sponsor's protocol ID
RFFG-2025-07
Status last verified
Feb 2026
First submitted
9 Feb 2026
Last updated
28 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HWS116 Injection in people with Advanced Solid Tumors, run by Wuhan Humanwell Innovative Drug Research and Development Center Limited Company at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ruihua Xu, Doctor (86-20-87343468, xurh@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Treatment-Emergent Adverse Events (Part 1 Only) (time frame: Up to 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07413328.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.

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