A Phase I Clinical Study of HS-20117 in Participants With Advanced Solid Tumors
NCT05940116 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 322
Last updated 2023-07-12
Summary
HS-20117 is a fully-human EGFR-MET immunoglobulin G1(IgG1)-like bispecific antibody. The purpose of study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of HS-20117 as a monotherapy for participants with advanced solid tumors.
Conditions
Interventions
- DRUG
-
HS-20117
Phase Ia: patients will receive HS-20117 starting at 400 mg, and subsequent cohorts will test escalating doses, if tolerated, until a maximum tolerated dose (MTD) or maximum applicable dose (MAD) is defined. Phase Ib: patients will receive HS-20117 at MED or MAD
Sponsors & Collaborators
-
Hansoh BioMedical R&D Company
lead INDUSTRY
Principal Investigators
-
Dingzhi Huang · Tianjin Medical University Cancer Institute and Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-07-20
- Primary Completion
- 2025-07-30
- Completion
- 2027-07-30
Countries
- China
Study Locations
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