Safety, Tolerability, Efficacy, Pharmacokinetics Profile and Immunogenicity of HS-20117 in Combination With Other Drugs in Advanced Solid Tumors, a Phase Ib Clinical Trial
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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, efficacy, PK profile and immunogenicity of HS-20117 in combination with other drugs in advanced solid tumors.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• Males or females aged 18 - 75 years (inclusive).
• Histologically confirmed unresectable, recurrent or metastatic solid tumors.
• At least one target lesion per the RECIST v1.1.
• ECOG performance status of 0-1.
• Minimum life expectancy \> 12 weeks.
• Males or Females should be using adequate contraceptive measures throughout the study.
• Females must not be pregnant at screening or have evidence of non-childbearing potential.
• Signed Informed Consent Form.
Locations
Other Locations
China
Tianjin Medical University Cancer Institute & Hospital
RECRUITING
Tianjin
Contact Information
Primary
Xiaowei Yan
yanxw@hspharm.com
13061877102
Time Frame
Start Date: 2024-12-14
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 780
Treatments
Experimental: Cohort 1a
NSCLC
Experimental: Cohort 2a
NSCLC
Experimental: Cohort 3a
CRC
Experimental: Cohort 4a
CRC
Experimental: Cohort 5a
CRC
Experimental: Cohort 6a
CRC
Related Therapeutic Areas
Sponsors
Leads: Hansoh BioMedical R&D Company