A Phase Ia/Ib Study of HW221043 in Participants With Advanced Solid Tumors
- Sponsor
- Hubei Bio-Pharmaceutical Industrial Technological Institute Inc.
- Study ID
- NCT07719920
- Phase
- PHASE1
- Status
- Not Yet Recruiting
Notify me when recruiting opens
Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.
Add your contact details and location so we can keep your interest tied to this study.
Conditions
- Advanced Solid Tumors
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- HW221043 Tablets — DRUGHW221043 Tablets for oral administration at specified doses on scheduled days.
Study Details
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 Dates
- First listed
- Jul 22, 2026
- Start date
- Jul 30, 2026
- Status verified
- Jul 2026
- Primary completion
- Jun 30, 2029
- Completion
- Dec 31, 2029
Study Design
- Enrollment
- 99 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: HW221043 Tablets Group
Primary Outcome Measure
Adverse Events (AE) or Serious Adverse Events (SAE) [ Time Frame: 2 years ]
Central Contacts
- Lifei Liu+86-27-87173753
Related Studies
- TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage CancerPHASE2 · Recruiting · American Society of Clinical Oncology · Birmingham, Alabama
- Metarrestin (ML-246) in Subjects With Metastatic Solid TumorsPHASE1 · Recruiting · National Cancer Institute (NCI) · Fairway, Kansas
- A Study of Calderasib (MK-1084) in KRAS Mutant Advanced Solid Tumors (MK-1084-001)PHASE1 · Recruiting · Merck Sharp & Dohme LLC · Tampa, Florida
- A TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND EFFICACY OF SHR-A1904 IN SUBJECTS WITH ADVANCED SOLID TUMORSPHASE1/PHASE2 · Recruiting · Jiangsu HengRui Medicine Co., Ltd. · Miami Beach, Florida