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

NCT07719920 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: HW221043-101
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (2)

• 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.

  2 years

• Dose Limited Toxicity (DLT)

  2 years

Secondary Outcomes (5)

• Maximum Plasma Concentration (Cmax)

  2 years

• Area Under the Concentration-Time Curve (AUC)

  2 years

• Tmax

  2 years

• Objective Response Rate (ORR)

  2 years to 3 years

• Progression-Free Survival (PFS)

  2 years to 3 years

Study Arms (1)

HW221043 Tablets Group

EXPERIMENTAL

Drug: HW221043 Tablets

Interventions

HW221043 Tablets DRUG

HW221043 Tablets for oral administration at specified doses on scheduled days.

HW221043 Tablets Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Hubei Bio-Pharmaceutical Industrial Technological Institute Inc.: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

Central Study Contacts

Lifei Liu

CONTACT

+86-27-87173753; liulifei@renfu.com.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2026
• First Posted: July 22, 2026
• Study Start: July 30, 2026
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: July 22, 2026

Record last verified: 2026-07

Locations

CN (1)