Actively Recruiting

Phase 1
Age: 18Years - 75Years
All Genders
NCT06621563

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

Led by Hansoh BioMedical R&D Company · Updated on 2025-04-09

780

Participants Needed

1

Research Sites

102 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Males or females aged 18 to 75 years (inclusive)
  • Histologically confirmed unresectable, recurrent, or metastatic solid tumors
  • At least one measurable target lesion per RECIST v1.1 criteria
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Life expectancy greater than 12 weeks
  • Use of adequate contraceptive measures throughout the study for males and females
  • Females must not be pregnant at screening and should have no evidence of childbearing potential
  • Signed informed consent form
Not Eligible

You will not qualify if you...

  • Received or are receiving anticancer therapies targeting MET, including tyrosine kinase inhibitors (TKIs), antibodies, or antibody-drug conjugates
  • Received monoclonal or bispecific antibodies targeting EGFR
  • Systemic anticancer treatments, including cytotoxic therapies, traditional Chinese medicine anticancer agents, or TKIs within 2 weeks prior to first HS-20117 dose
  • Investigational anticancer drugs, antibodies, or antibody-drug conjugates within 4 weeks prior to first HS-20117 dose
  • Local radiotherapy within 2 weeks prior to first HS-20117 dose, or more than 30% bone marrow irradiation or large-area radiotherapy within 4 weeks prior
  • Presence of pleural effusion or ascites requiring intervention, or pericardial effusion
  • Major surgery within 4 weeks prior to first HS-20117 dose
  • Grade 2 or higher toxicities from prior antitumor therapy
  • Uncured secondary primary malignancies
  • Untreated or active central nervous system metastases
  • Severe, uncontrolled, or active cardiovascular disorders
  • Serious infection within 4 weeks prior to first HS-20117 dose

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Tianjin Medical University Cancer Institute & Hospital

Tianjin, China

Actively Recruiting

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Research Team

X

Xiaowei Yan

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

6

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