A Phase Ia/Ib Study of HW221043 in Participants With Advanced Solid Tumors

Starting soon · Phase 1

Conditions studied: Advanced Solid Tumors

In brief

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).

Key facts

Study ID: NCT07719920
Run by: Hubei Bio-Pharmaceutical Industrial Technological Institute Inc.
People needed: 99
Starts: 2026-07-30
Expected to finish: 2029-12-31
Last updated by the study team: 2026-07-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.
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.

You may not qualify if…

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.
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.

Where it is running

Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China

Full record on ClinicalTrials.gov

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