Advanced Solid TumorsPhase 1NCT07719920
A Phase Ia/Ib Study of HW221043 in Participants With Advanced Solid Tumors
A Phase 1 study testing HW221043 Tablets in people with Advanced Solid Tumors, run by Hubei Bio-Pharmaceutical Industrial Technological Institute Inc. at 1 site in China.
Trial summary
This is a Phase Ia/Ib, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, and preliminary efficacy of HW221043 tablets in participants with advanced solid tumors. It includes two parts: the dose escalation study (Phase Ia) and the dose expansion study (Phase Ib). 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?
- HW221043 Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteChina
- Study dates
- 10 Sep 2026to 31 Dec 2029
- 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
- Men or women ≥18 years old.
- Histologically and/or cytologically confirmed recurrent or metastatic advanced solid tumors.
- Absence of available standard therapy, failure of standard therapy, or ineligibility for standard therapy.
- Survival expectation is ≥12 weeks.
- Adequate major organ function at screening; no blood transfusion or hematopoietic growth factor administration within 14 days prior to screening; and no significant abnormalities in hematology, coagulation profiles, or blood chemistry.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
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- Presence of at least one measurable target lesion as defined by RECIST 1.1
- Participants are willing to provide tumor tissue samples.
- Participants of childbearing potential must be non-pregnant at screening. Male and female of childbearing potential must agree to use effective methods of contraception throughout the study.
- Participants must have demonstrated a full understanding of the study, voluntarily signed the informed consent form (ICF), and be willing and able to comply with all study procedures and required follow-up visits.
Who cannot join
- Allergic to HW221043 Tablet or its components.
- Has a treatment history of KIF18A inhibitor.
- Known presence of a recognizable hypermutated phenotype.
- Prior receipt of any unapproved investigational drug or therapy within 28 days before first dose.
- Inadequate washout from prior antitumor therapy.
- Use of any medication that may interfere with the safety conduct of the study within 14 days prior to the first dose (or within at least 5 half-lives of the agent, whichever is longer), or planned use of such medications during the study period.
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- Continuous use of systemic corticosteroids within 4 weeks prior to the first dose.
- Live vaccination within 28 days prior to first dose or anticipated during the study.
- Major surgery within 28 days prior to the first dose of the investigational product.
- Major surgical procedure within 28 days prior to first dose.
- History of another active malignancy within 3 years prior to initiation of the investigational product.
- ≥ Grade 2 prior antitumor therapy-related toxicity per CTCAE v6.0 (except abnormalities deemed clinically insignificant).
- Tumor invasion into adjacent vital organs, major vessels, or central nervous system (CNS), or evidence of progressive brain metastases.
- Presence of severe underlying pulmonary disease, severe cardiac/cerebrovascular disease, or clinically significant QTc prolongation.
- Presence of an active infectious disease.
- Diagnosis of an autoimmune disease or presence of an immunodeficient state.
- Inability to swallow oral medications, or uncontrolled nausea, vomiting, diarrhea, or other gastrointestinal dysfunction likely to affect drug absorption.
- History of alcohol abuse or substance abuse.
- Women who are pregnant, breastfeeding, or planning to become pregnant/ breastfeeding during the study.
- Any condition that, in the judgment of the Investigator, would make 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.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Xiaohua Wu, Doctorate, +86-21-64175590 ext. 81000, wu.xh@fudan.edu.cn
Jian Zhang, Doctorate, +8618017312991, syner2000@163.com
About this study
Official title: A Phase I Study Evaluating the Safety, Pharmacokinetics, and Efficacy of HW221043 Tablets in Participants With Advanced Solid Tumors
This is a Phase Ia/Ib, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, and preliminary efficacy of HW221043 tablets in participants with advanced solid tumors. It includes two parts: the dose escalation study (Phase Ia) and the dose expansion study (Phase Ib).
- Conditions
- Advanced Solid Tumors
- Being tested
- HW221043 Tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HW221043 TabletsDrug
HW221043 Tablets for oral administration at specified doses on scheduled days.
| Study group | Role | What they receive |
|---|---|---|
| HW221043 Tablets Group | Experimental | Not described Receives: Drug: HW221043 Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events (AE) or Serious Adverse Events (SAE)
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) according to NCI CTCAE 6.0.
Measured: 2 years
Dose Limited Toxicity (DLT)
Measured: 2 years
Secondary outcomes (5)
Maximum Plasma Concentration (Cmax)
Highest Plasma Concentration of HW221043
Measured: 2 years
Area Under the Concentration-Time Curve (AUC)
Measured: 2 years
Tmax
Time to Achieve Cmax
Measured: 2 years
Objective Response Rate (ORR)
Measured: 2 years to 3 years
Progression-Free Survival (PFS)
Measured: 2 years to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start10 Sep 2026
- Primary completion30 Jun 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Single group
- Masking
- None (open label)
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hubei Bio-Pharmaceutical Industrial Technological Institute Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07719920
- Sponsor's protocol ID
- HW221043-101
- Status last verified
- Sep 2026
- First submitted
- 17 Jul 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Final decisions on IPD sharing will be informed by a comprehensive assessment of data completeness, quality, and participant privacy protections once the database is locked. The registration will be updated accordingly at that time.
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study Evaluating the Safety, Pharmacokinetics, and Efficacy of HW221043 Tablets in Participants With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07719920
- Acronym / sponsor ID
- HW221043-101
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- Hubei Bio-Pharmaceutical Industrial Technological Institute Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Sep 2026 (actual)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 22 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase Ia/Ib, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, and preliminary efficacy of HW221043 tablets in participants with advanced solid tumors. It includes two parts: the dose escalation study (Phase Ia) and the dose expansion study (Phase Ib).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HW221043 Tablets Group | Experimental | Drug: HW221043 Tablets |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Men or women ≥18 years old.
- Histologically and/or cytologically confirmed recurrent or metastatic advanced solid tumors.
- Absence of available standard therapy, failure of standard therapy, or ineligibility for standard therapy.
- Survival expectation is ≥12 weeks.
- Adequate major organ function at screening; no blood transfusion or hematopoietic growth factor administration within 14 days prior to screening; and no significant abnormalities in hematology, coagulation profiles, or blood chemistry.
Key exclusion criteria (20 listed)
- Allergic to HW221043 Tablet or its components.
- Has a treatment history of KIF18A inhibitor.
- Known presence of a recognizable hypermutated phenotype.
- Prior receipt of any unapproved investigational drug or therapy within 28 days before first dose.
- Inadequate washout from prior antitumor therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HW221043 TabletsHW221043 Tablets for oral administration at specified doses on scheduled days. | Drug | HW221043 Tablets Group |
Primary outcome
Adverse Events (AE) or Serious Adverse Events (SAE)
Time frame: 2 years
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) according to NCI CTCAE 6.0.
Dose Limited Toxicity (DLT)
Time frame: 2 years
5 secondary outcomes
Maximum Plasma Concentration (Cmax)
Time frame: 2 years
Area Under the Concentration-Time Curve (AUC)
Time frame: 2 years
Tmax
Time frame: 2 years
Objective Response Rate (ORR)
Time frame: 2 years to 3 years
Progression-Free Survival (PFS)
Time frame: 2 years to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: Undecided. Final decisions on IPD sharing will be informed by a comprehensive assessment of data completeness, quality, and participant privacy protections once the database is locked. The registration will be updated accordingly at that time.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HW221043 Tablets in people with Advanced Solid Tumors, run by Hubei Bio-Pharmaceutical Industrial Technological Institute Inc. 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 10 inclusion and 20 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 11 Sep 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 Lifei Liu (+86-27-87173753, liulifei@renfu.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (AE) or Serious Adverse Events (SAE) (time frame: 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?
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 11 Sep 2026.