RecruitingPhase 1NCT06621563

Phase Ib Trial of HS-20117 in Combination With Other Drugs in Advanced Solid Tumors

Safety, Tolerability, Efficacy, Pharmacokinetics Profile and Immunogenicity of HS-20117 in Combination With Other Drugs in Advanced Solid Tumors, a Phase Ib Clinical Trial

Sponsor

Hansoh BioMedical R&D Company

Enrollment

780 participants

Start Date

Dec 14, 2024

Study Type

INTERVENTIONAL

Conditions

Solid Tumors

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

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria8

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 \&amp;gt; 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.

Exclusion Criteria13

Received or are receiving the following treatments:
Any anticancer therapy targeting MET, including TKIs, antibodies or antibody-drug conjugates.
Monoclonalor bispecific antibodies targeting EGFR.
Systemic anti-cancer treatment (Cytotoxicities and anti-cancer Traditional Chinese medicine or TKIs) within 2 weeks prior to the first dose of HS-20117.
Investigational anti-cancer drugs or antibodies or ADCs within 4 weeks prior to the first dose of HS-20117.
Local radiotherapy within 2 weeks prior to the first dose of HS-20117, more than 30% of bone marrow irradiation or large-area radiotherapy within 4 weeks before the first dose of HS-20117.
Presence of pleural effusion/ascites requiring clinical intervention; presence of pericardial effusion.
Major surgery within 4 weeks prior to the first dose of HS-20117.
Presence of Grade ≥ 2 toxicities due to prior anti-tumor therapy.
Presence of uncured secondary primary malignancies.
Untreated, or active central nervous system metastases.
Severe, uncontrolled or active cardiovascular disorders.
Serious infection within 4 weeks prior to the first dose of HS-20117.