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TerminatedNCT06202521Updated Jan 8, 2026Results posted

CX-4945 in Viral Community Acquired Pneumonia

A Phase 2 interventional study of CX-4945 (SARS-CoV-2 domain) and Placebo (SARS-CoV-2 domain) in Community-acquired Pneumonia, SARS-CoV-2 -Associated Pneumonia and Influenza With Pneumonia, sponsored by Senhwa Biosciences, Inc.. Terminated at 7 sites in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-08.

Sponsored by Senhwa Biosciences, Inc. · Phase 2, Interventional, and Treatment

Why this study was terminated
The trial ended early in March 2025 due to changes in disease epidemiology, affecting patient availability and recruitment feasibility.
Phase
Phase 2
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This is a Phase II, multi-center, double-blind, randomized, interventional study in approximately 120 subjects to evaluate clinical benefit of CX-4945 in adult outpatients with SARS-CoV-2 and influenza viral infection-associated pneumonia. The subjects will be recruited into two domains, including SARS-CoV-2 and influenza virus domains. The study will compare the efficacy of Standard of Care (SOC) combined with CX-4945 against SOC paired with a placebo, utilizing a 1:1 allocation ratio in each domain.

Read the detailed description

Domain I: SARS-CoV-2 domain

  • Arm 1: CX-4945 (400 mg BID for 5 days) +SOC
  • Arm 2: Placebo + SOC

Domain II: Influenza virus domain

  • Arm 3: CX-4945 (400 mg BID for 5 days) +SOC
  • Arm 4: Placebo + SOC

Screening visit will collect health information and perform protocol specified tests to determine patients' eligibility. After screening visit, eligible subjects who fulfill all selection criteria for enrollment will be randomized into each of the arms. The CX-4945 will be administered at 400 mg BID for 5 days. Subjects will be followed up until Day 29.

02

Conditions studied

  • Community-acquired Pneumonia
  • SARS-CoV-2 -Associated Pneumonia
  • Influenza With Pneumonia

Keywords

  • Covid-19
  • Influenza
  • Community-acquired Pneumonia
03

In context

Community-Acquired Pneumonia

82 studies on the registry are indexed under Community-Acquired Pneumonia; 51 are open to participants now.

This study's enrollment of 45 is below the median of 326 across 53 interventional studies indexed under Community-Acquired Pneumonia.

Browse Community-Acquired Pneumonia studies →

Lead sponsor

Senhwa Biosciences, Inc. is the lead sponsor of 6 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Not currently hospitalized
  2. Males or females aged ≥ 18 years at the time of signing the informed consent form (ICF)
  3. Patients diagnosed with viral pneumonia, as determined by the investigator, who exhibit any of the subsequent criteria: presence of respiratory symptoms or fever (ear temperature ≥ 38 °C, base of the tongue temperature ≥ 37.5 °C, or axillary temperature ≥ 37 °C)
  4. With a pneumonia severity index (PSI) of risk class II or III
  5. Oxygen saturation measured by pulse oximetry (SpO2) ≥ 94% on room air at sea level
  6. Positive test for SARS-CoV-2 or influenza virus infection, confirmed by rapid diagnostic test (excluding cases where both SARS-CoV-2 and influenza virus are positive)
  7. Confirmed lower respiratory tract infection by X-ray
  8. At screening, subjects capable of childbearing must provide a negative serum or urine pregnancy test. These subjects must also commit to adhering to the study-specified contraceptive methods throughout the study duration

    Notes: Acceptable contraceptive methods include:

    • Established use of oral, injected or implanted hormonal methods of contraception
    • Placement of an intrauterine device (IUD) or intrauterine system (IUS)
    • Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps)
  9. The participant (or legal representative) agrees and is able to adhere to study protocol-stated requirements, instructions, and restrictions in the investigator's judgement. Furthermore, the participant is capable of understanding and has signed the IRB-approved Informed Consent Form (ICF)
  10. With at least two of the risk factors listed below: Age ≥ 50 years-old; cancer and a life expectancy of ≥ 6 months; HIV infection; immunocompromised patient; congestive heart failure (CHF), or coronary artery disease (CAD), or cardiomyopathies; chronic kidney disease (CKD); chronic liver disease; chronic lung disease; diabetes mellitus (DM); body mass index (BMI) > 25 kg/m2; asthma; cerebrovascular disease; cystic fibrosis; dementia; or current and former smoker

Exclusion criteria

Exclusion Criteria

  1. Subject received investigational treatment within 30 days prior to the study, or concurrent use of another investigational drug
  2. Subject has a history of severe renal disease (required phosphate binders or dialysis)
  3. Subject has chronic diarrhea, characterized by three or more loose stools daily for a minimum of four weeks
  4. High likelihood of mortality within the next 48 hours, as assessed by the investigator
  5. Subject showing signs of respiratory failure and mechanical ventilation is required
  6. Subject with liver cirrhosis
  7. Subject with hepatitis B and/or hepatitis C disease, unless the subject has an aspartate aminotransferase (AST) level ranging from 8 to 31 U/L and an alanine aminotransferase (ALT) level from 0 to 41 U/L
  8. Known active tuberculosis
  9. Current documented bacterial infection
  10. Subject has a documented anaphylactic reaction, regardless of cause
  11. Subject who has taken an antiviral agent against respiratory viral infection for a continuous duration of more than 24 hours before screening
  12. Subject is with active gastrointestinal diseases including gastritis, ulcerative colitis, Crohn's disease, or hemorrhagic coloproctitis
  13. Subjects received warfarin within 14 days prior to screening or intend to during the screening or treatment phase
  14. History of allergic reactions to any of the ingredients or components used in the manufacture of CX-4945
  15. Women who are pregnant or breastfeeding, or planning pregnancy during the study

    Note: Men and women of reproductive potential must commit to effective contraception methods or abstinence during the study. Any resulting pregnancies or suspected pregnancies must be reported to the treating physician immediately.

  16. ALT or AST levels > 5 times upper limit of normal (ULN)
  17. eGFR \<30 mL/min/1.73m2 (calculated by the MDRD formula)
  18. Absolute neutrophil count (ANC) \<1000/μL
  19. Have received treatment with a SARS-CoV-2 specific monoclonal antibody
  20. Have received convalescent COVID-19 plasma treatment
  21. Concurrent use of baricitinib
  22. Any physical findings or illness history that may compromise study results or increase patient risk, as determined by the investigator
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
45 participants (actual)

Study arms

  • Experimental
    SARS-CoV-2 domain: CX-4945 (400 mg BID for 5 days) +SOC

    Notes: The SOC within the SARS-CoV-2 domain is defined as the medications in use at each respective site for the treatment of CAP related to SARS-CoV-2 infection.

    Drug: CX-4945 (SARS-CoV-2 domain)

  • Placebo comparator
    SARS-CoV-2 domain: Placebo + SOC

    Notes: The SOC within the SARS-CoV-2 domain is defined as the medications in use at each respective site for the treatment of CAP related to SARS-CoV-2 infection.

    Drug: Placebo (SARS-CoV-2 domain)

  • Experimental
    Influenza virus domain: CX-4945 (400 mg BID for 5 days) +SOC

    Notes: The SOC within the influenza virus domain is defined as the medications in use at each respective site for the treatment of CAP related to influenza virus infection.

    Drug: CX-4945 (Influenza virus domain)

  • Placebo comparator
    Influenza virus domain: Placebo + SOC

    Notes: The SOC within the influenza virus domain is defined as the medications in use at each respective site for the treatment of CAP related to influenza virus infection.

    Drug: Placebo (Influenza virus domain)

Interventions

  • DrugCX-4945 (SARS-CoV-2 domain)

    CX-4945 will be administered at 400 mg BID for up to 5 days (Day 1 to Day 5) in addition to SOC.

    Also known as: Silmitasertib

  • DrugPlacebo (SARS-CoV-2 domain)

    The dosage and frequency is the same as active drug.

  • DrugCX-4945 (Influenza virus domain)

    CX-4945 will be administered at 400 mg BID for up to 5 days (Day 1 to Day 5) in addition to SOC.

    Also known as: Silmitasertib

  • DrugPlacebo (Influenza virus domain)

    The dosage and frequency is the same as active drug.

06

What researchers measure

Primary outcomes

  1. The Percentage of Subjects Requiring Hospitalization, Including Emergency Room Visits, or Resulting in Death Due to Progression of CAP Related to SARS-CoV-2 or Influenza.

    To evaluate the effect of intervention with Silmitasertib (CX-4945) in addition to SOC, compared to placebo plus SOC, in preventing the progression of CAP associated with SARS-CoV-2 and influenza virus infection

    Time frame: Day 1 to Day 29

Secondary outcomes

  1. The Percentage of Subjects With All Cause Hospitalization, Emergency Room Visits, or Death During Study Period.

    To evaluate the effect of intervention with Silmitasertib (CX-4945) in addition to SOC, compared with placebo plus SOC, in enhancing the subject's clinical condition

    Time frame: Day 1 to Day 29

  2. The Percentage of Subjects With Improved Pulmonary X-ray Findings for Pneumonia, Relative to Baseline or Showing a Return to Normalcy

    To evaluate the effect of intervention with Silmitasertib (CX-4945) in addition to SOC, compared with placebo plus SOC, in enhancing the subject's clinical condition. Note: Visit 3 and its associated efficacy/safety assessments were scheduled for Day 5 in protocol version 1.0 and for Day 7 since protocol version 2.0.

    Time frame: Baseline to Day 5/7

  3. The Symptom Resolution for Fever is Defined as Body Temperature Lower Than the Following Definition for 24 Hours (Ear Temperature < 38 °C, Base of the Tongue Temperature < 37.5 °C, or Axillary Temperature < 37 °C)

    Time to Symptom Resolution for Fever \[days\]. The symptom resolution for fever is defined as body temperature lower than the following definition (ear temperature \< 38 °C, base of the tongue temperature \< 37.5 °C, or axillary temperature \< 37 °C) Note: Visit 3 and its associated efficacy/safety assessments were scheduled for Day 5 in protocol version 1.0 and for Day 7 since protocol version 2.0.

    Time frame: Day 1 to Day 5/7

  4. Change From Baseline in SpO2/FiO2 Ratio

    To evaluate the effect of intervention with Silmitasertib (CX-4945) in addition to SOC, compared with placebo plus SOC, in enhancing the subject's clinical condition Note: Visit 3 and its associated efficacy/safety assessments were scheduled for Day 5 in protocol version 1.0 and for Day 7 since protocol version 2.0.

    Time frame: Day 1 to Day 5/7, 15, and 29

  5. The Percentage of Subjects Exhibiting Disease Progression in Health Status Disease Progression is Defined as an Increase of Score on the National Institute of Allergy and Infectious Diseases (NIAID) 8-point Ordinal Scale

    To evaluate the effect of intervention with Silmitasertib (CX-4945) in addition to SOC, compared with placebo plus SOC, in enhancing the subject's clinical condition. NIAID 8-point ordinal scale range: 1-8, with higher scores indicating a worse condition. Note: Visit 3 and its associated efficacy/safety assessments were scheduled for Day 5 in protocol version 1.0 and for Day 7 since protocol version 2.0.

    Time frame: Day 1 to Day 5/7, 15, and 29

  6. The Percentage of Subjects Exhibiting Health Improvement in Health Status Health Improvement is Defined as a Reduction of Score on the National Institute of Allergy and Infectious Diseases (NIAID) 8-point Ordinal Scale

    To evaluate the effect of intervention with Silmitasertib (CX-4945) in addition to SOC, compared with placebo plus SOC, in enhancing the subject's clinical condition NIAID 8-point ordinal scale range: 1-8, with higher scores indicating a worse condition. Note: Visit 3 and its associated efficacy/safety assessments were scheduled for Day 5 in protocol version 1.0 and for Day 7 since protocol version 2.0.

    Time frame: Day 1 to Day 5/7, 15, and 29

07

Results

Posted Jan 8, 2026
Limitations and caveats
This trial was terminated early on March 31, 2025 due to insufficient differentiation of the primary endpoint in addressing the unmet medical need, as well as recruitment difficulties caused by the end of the flu season.

Participant flow

Participants were recruited from individuals diagnosed with Community-Acquired Pneumonia (CAP) associated with SARS-CoV-2 and influenza viral infections at seven sites across Taiwan between February 2024 and March 2025. The first participant was enrolled on March 20, 2024, and the last on February 27, 2025.

Participant flow — Overall Study
MilestoneSARS-CoV-2 Domain: CX-4945 + SOCSARS-CoV-2 Domain: Placebo + SOCInfluenza Virus Domain: CX-4945 + SOCInfluenza Virus Domain: Placebo + SOC
Started151577
Completed151466
Not completed0111
Withdrew: Withdrawal by subject0101
Withdrew: Adverse event0010

Outcome measures

PrimaryThe Percentage of Subjects Requiring Hospitalization, Including Emergency Room Visits, or Resulting in Death Due to Progression of CAP Related to SARS-CoV-2 or Influenza.

To evaluate the effect of intervention with Silmitasertib (CX-4945) in addition to SOC, compared to placebo plus SOC, in preventing the progression of CAP associated with SARS-CoV-2 and influenza virus infection

Time frame:
Day 1 to Day 29
Reported as:
Count of participants · Participants
The Percentage of Subjects Requiring Hospitalization, Including Emergency Room Visits, or Resulting in Death Due to Progression of CAP Related to SARS-CoV-2 or Influenza.
ParticipantsSARS-CoV-2 domain: CX-4945 + SOCSARS-CoV-2 domain: Placebo + SOCInfluenza virus domain: CX-4945 + SOCInfluenza virus domain: Placebo + SOC
The Percentage of Subjects Requiring Hospitalization, Including Emergency Room Visits, or Resulting in Death Due to Progression of CAP Related to SARS-CoV-2 or Influenza.0000
SecondaryThe Percentage of Subjects With All Cause Hospitalization, Emergency Room Visits, or Death During Study Period.

To evaluate the effect of intervention with Silmitasertib (CX-4945) in addition to SOC, compared with placebo plus SOC, in enhancing the subject's clinical condition

Time frame:
Day 1 to Day 29
Reported as:
Count of participants · Participants
The Percentage of Subjects With All Cause Hospitalization, Emergency Room Visits, or Death During Study Period.
ParticipantsSARS-CoV-2 domain: CX-4945 + SOCSARS-CoV-2 domain: Placebo + SOCInfluenza virus domain: CX-4945 + SOCInfluenza virus domain: Placebo + SOC
The Percentage of Subjects With All Cause Hospitalization, Emergency Room Visits, or Death During Study Period.0110
SecondaryThe Percentage of Subjects With Improved Pulmonary X-ray Findings for Pneumonia, Relative to Baseline or Showing a Return to Normalcy

To evaluate the effect of intervention with Silmitasertib (CX-4945) in addition to SOC, compared with placebo plus SOC, in enhancing the subject's clinical condition. Note: Visit 3 and its associated efficacy/safety assessments were scheduled for Day 5 in protocol version 1.0 and for Day 7 since protocol version 2.0.

Time frame:
Baseline to Day 5/7
Reported as:
Count of participants · Participants
The Percentage of Subjects With Improved Pulmonary X-ray Findings for Pneumonia, Relative to Baseline or Showing a Return to Normalcy
ParticipantsSARS-CoV-2 domain: CX-4945 + SOCSARS-CoV-2 domain: Placebo + SOCInfluenza virus domain: CX-4945 + SOCInfluenza virus domain: Placebo + SOC
Day 5/7 — Worsen1110
Day 5/7 — No change1130
Day 5/7 — Improved8715
Day 5/7 — Normal5621
Day 15 — Worsen0000
Day 15 — No change1000
Day 15 — Improved5532
Day 15 — Normal9934
Day 29 — Worsen0000
Day 29 — No change0000
Day 29 — Improved1020
Day 29 — Normal141446
SecondaryThe Symptom Resolution for Fever is Defined as Body Temperature Lower Than the Following Definition for 24 Hours (Ear Temperature < 38 °C, Base of the Tongue Temperature < 37.5 °C, or Axillary Temperature < 37 °C)

Time to Symptom Resolution for Fever \[days\]. The symptom resolution for fever is defined as body temperature lower than the following definition (ear temperature \< 38 °C, base of the tongue temperature \< 37.5 °C, or axillary temperature \< 37 °C) Note: Visit 3 and its associated efficacy/safety assessments were scheduled for Day 5 in protocol version 1.0 and for Day 7 since protocol version 2.0.

Time frame:
Day 1 to Day 5/7
Reported as:
Median · days
The Symptom Resolution for Fever is Defined as Body Temperature Lower Than the Following Definition for 24 Hours (Ear Temperature < 38 °C, Base of the Tongue Temperature < 37.5 °C, or Axillary Temperature < 37 °C)
daysSARS-CoV-2 domain: CX-4945 + SOCSARS-CoV-2 domain: Placebo + SOCInfluenza virus domain: CX-4945 + SOCInfluenza virus domain: Placebo + SOC
The Symptom Resolution for Fever is Defined as Body Temperature Lower Than the Following Definition for 24 Hours (Ear Temperature < 38 °C, Base of the Tongue Temperature < 37.5 °C, or Axillary Temperature < 37 °C)1.8 (NA to NA)1.2 (NA to NA)1.8 (1.20 to NA)1.7 (1.50 to NA)
SecondaryChange From Baseline in SpO2/FiO2 Ratio

To evaluate the effect of intervention with Silmitasertib (CX-4945) in addition to SOC, compared with placebo plus SOC, in enhancing the subject's clinical condition Note: Visit 3 and its associated efficacy/safety assessments were scheduled for Day 5 in protocol version 1.0 and for Day 7 since protocol version 2.0.

Time frame:
Day 1 to Day 5/7, 15, and 29
Reported as:
Mean · ratio change
Change From Baseline in SpO2/FiO2 Ratio
ratio changeSARS-CoV-2 domain: CX-4945 + SOCSARS-CoV-2 domain: Placebo + SOCInfluenza virus domain: CX-4945 + SOCInfluenza virus domain: Placebo + SOC
Day 5/70.95 ± 3.6890.63 ± 4.3592.04 ± 4.6470.68 ± 5.091
Day 150.95 ± 2.6701.36 ± 4.7363.17 ± 6.5061.59 ± 3.888
Day 291.59 ± 3.4461.70 ± 6.0834.76 ± 3.0122.38 ± 5.832
SecondaryThe Percentage of Subjects Exhibiting Disease Progression in Health Status Disease Progression is Defined as an Increase of Score on the National Institute of Allergy and Infectious Diseases (NIAID) 8-point Ordinal Scale

To evaluate the effect of intervention with Silmitasertib (CX-4945) in addition to SOC, compared with placebo plus SOC, in enhancing the subject's clinical condition. NIAID 8-point ordinal scale range: 1-8, with higher scores indicating a worse condition. Note: Visit 3 and its associated efficacy/safety assessments were scheduled for Day 5 in protocol version 1.0 and for Day 7 since protocol version 2.0.

Time frame:
Day 1 to Day 5/7, 15, and 29
Reported as:
Count of participants · Participants
The Percentage of Subjects Exhibiting Disease Progression in Health Status Disease Progression is Defined as an Increase of Score on the National Institute of Allergy and Infectious Diseases (NIAID) 8-point Ordinal Scale
ParticipantsSARS-CoV-2 domain: CX-4945 + SOCSARS-CoV-2 domain: Placebo + SOCInfluenza virus domain: CX-4945 + SOCInfluenza virus domain: Placebo + SOC
Day 5/70000
Day 150010
Day 290000
SecondaryThe Percentage of Subjects Exhibiting Health Improvement in Health Status Health Improvement is Defined as a Reduction of Score on the National Institute of Allergy and Infectious Diseases (NIAID) 8-point Ordinal Scale

To evaluate the effect of intervention with Silmitasertib (CX-4945) in addition to SOC, compared with placebo plus SOC, in enhancing the subject's clinical condition NIAID 8-point ordinal scale range: 1-8, with higher scores indicating a worse condition. Note: Visit 3 and its associated efficacy/safety assessments were scheduled for Day 5 in protocol version 1.0 and for Day 7 since protocol version 2.0.

Time frame:
Day 1 to Day 5/7, 15, and 29
Reported as:
Count of participants · Participants
The Percentage of Subjects Exhibiting Health Improvement in Health Status Health Improvement is Defined as a Reduction of Score on the National Institute of Allergy and Infectious Diseases (NIAID) 8-point Ordinal Scale
ParticipantsSARS-CoV-2 domain: CX-4945 + SOCSARS-CoV-2 domain: Placebo + SOCInfluenza virus domain: CX-4945 + SOCInfluenza virus domain: Placebo + SOC
Day 5/72121
Day 154221
Day 295221

Adverse events

Collected over From randomization until end of follow-up, up to 32 days. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
SARS-CoV-2 Domain: CX-4945 + SOC0/15 (0%)0/15 (0%)10/15 (66.7%)
SARS-CoV-2 Domain: Placebo + SOC0/15 (0%)0/15 (0%)4/15 (26.7%)
Influenza Virus Domain: CX-4945 + SOC0/7 (0%)1/7 (14.3%)5/7 (71.4%)
Influenza Virus Domain: Placebo + SOC0/7 (0%)0/7 (0%)5/7 (71.4%)
Most frequent serious events
Most frequent serious events
EventSARS-CoV-2 Domain: CX-4945 + SOCSARS-CoV-2 Domain: Placebo + SOCInfluenza Virus Domain: CX-4945 + SOCInfluenza Virus Domain: Placebo + SOC
Pneumonia bacterialInfections and infestations0/150/151/70/7
Most frequent other events
Showing 10 of 33
Most frequent other events
EventSARS-CoV-2 Domain: CX-4945 + SOCSARS-CoV-2 Domain: Placebo + SOCInfluenza Virus Domain: CX-4945 + SOCInfluenza Virus Domain: Placebo + SOC
DiarrhoeaGastrointestinal disorders7/151/154/73/7
NauseaGastrointestinal disorders4/151/151/70/7
ConstipationGastrointestinal disorders0/150/151/71/7
Mouth ulcerationGastrointestinal disorders0/150/150/71/7
DysphoniaRespiratory, thoracic and mediastinal disorders1/150/151/70/7
CoughRespiratory, thoracic and mediastinal disorders0/150/151/70/7
EpistaxisRespiratory, thoracic and mediastinal disorders0/150/151/70/7
Nasal congestionRespiratory, thoracic and mediastinal disorders0/150/151/70/7
Oropharyngeal painRespiratory, thoracic and mediastinal disorders0/150/151/70/7
RhinorrhoeaRespiratory, thoracic and mediastinal disorders0/150/151/70/7

Baseline characteristics

The ITT population is defined as all randomized subjects who received at least one dose of Silmitasertib (CX-4945) or placebo. This population was used as the primary analysis population for efficacy endpoints and the analysis population for baseline data, safety and exploratory endpoints.

Age, Continuous
Age, Continuous(years)SARS-CoV-2 Domain: CX-4945 + SOCSARS-CoV-2 Domain: Placebo + SOCInfluenza Virus Domain: CX-4945 + SOCInfluenza Virus Domain: Placebo + SOCTotal
Mean46.3 ± 11.8847.4 ± 11.0448.6 ± 13.3549.0 ± 14.3347.5 ± 11.84
Sex: Female, Male
Sex: Female, Male(Participants)SARS-CoV-2 Domain: CX-4945 + SOCSARS-CoV-2 Domain: Placebo + SOCInfluenza Virus Domain: CX-4945 + SOCInfluenza Virus Domain: Placebo + SOCTotal
Female982423
Male675321
Race (NIH/OMB)
Race (NIH/OMB)(Participants)SARS-CoV-2 Domain: CX-4945 + SOCSARS-CoV-2 Domain: Placebo + SOCInfluenza Virus Domain: CX-4945 + SOCInfluenza Virus Domain: Placebo + SOCTotal
American Indian or Alaska Native00000
Asian15157744
Native Hawaiian or Other Pacific Islander00000
Black or African American00000
White00000
More than one race00000
Unknown or Not Reported00000
08

Study locations

7 sites
  • Kaohsiung Veterans General Hospital
    Kaohsiung City, Taiwan
  • Far Eastern Memorial Hospital
    New Taipei City, Taiwan
  • Taichung Veterans General Hospital
    Taichung, Taiwan
  • National Taiwan University Cancer Center, National Taiwan University Hospital
    Taipei, Taiwan
  • National Taiwan University Hospital
    Taipei, Taiwan
  • Tri-Service General Hospital
    Taipei, Taiwan
  • Taoyuan General Hospital, Ministry of Health and Welfare
    Taoyuan, Taiwan
09

References and documents

Study documents

  • Study protocol · Aug 16, 2024
  • Statistical analysis plan · Jun 25, 2025

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT06202521
Lead sponsor
Senhwa Biosciences, Inc.
Responsible party
Sponsor
First posted
Jan 11, 2024
Start date
Mar 20, 2024
Primary completion
Apr 22, 2025
Completion
Apr 22, 2025
Results posted
Jan 8, 2026
Last update
Jan 8, 2026

Study contacts

Jason Huang, M.D.
study chair · Senhwa Biosciences

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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