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

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Conditions

  • Advanced Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • HW221043 Tablets — DRUG
    HW221043 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

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