Not yet recruiting NCT07719920
A Phase Ia/Ib Study of HW221043 in Participants With Advanced Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HW221043 Tablets.
- Who it may be relevant to
- Registry conditions: Advanced Solid Tumors. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase I Study Evaluating the Safety, Pharmacokinetics, and Efficacy of HW221043 Tablets in Participants With Advanced Solid Tumors
Overview
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).
Interventions
- Drug HW221043 Tablets
HW221043 Tablets for oral administration at specified doses on scheduled days.
Primary outcome measures
- Adverse Events (AE) or Serious Adverse Events (SAE) [Time frame: 2 years]
- Dose Limited Toxicity (DLT) [Time frame: 2 years]
Secondary outcome measures (5)
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Fudan University Shanghai Cancer Center — Shanghai
Identifiers
NCT: NCT07719920 · HW221043-101