HW221043 in people with advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a two-part Phase 1 study: a dose-escalation portion to determine safe dose levels of HW221043, followed by a dose-expansion portion to further assess safety and look for early signs of activity. Adults with recurrent or metastatic solid tumors and no effective standard therapies will be enrolled, with requirements including measurable disease, adequate organ function, and ECOG 0-1. The study will evaluate safety, tolerability, pharmacokinetics, and preliminary efficacy of HW221043 tablets. Participation involves tumor tissue collection and ongoing monitoring for adverse events.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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's running

• Fudan University Shanghai Cancer Center
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Lifei Liu
• Email: liulifei@renfu.com.cn
• Phone: +86-27-87173753

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.