Phase Ib Trial of HS-20117 in Combination With Other Drugs in Advanced Solid Tumors
Recruiting · NCT06621563 · Interventional (participants receive a specific treatment) · Lead sponsor: Hansoh BioMedical R&D Company
View the official record on ClinicalTrials.gov →Interventions studied
HS-20117 combined HS-20093HS-20117 combined HS-20093 and 5-FUHS-20117 combined Platinum-containing chemotherapyHS-20117+CAPEOXHS-20117+FOLFIRIHS-20117+mFOLFOX6
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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Where it is running
1 location listed.
- Tianjin Medical University Cancer Institute & Hospital - Tianjin, China