Overview
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.
Description
This is a multicenter, open-label, Phase Ib clinical trial of HS-20117 combination therapies to evaluate the safety, tolerability, efficacy, PK profile and immunogenicity in participants with advanced solid tumors. The study includes a dose escalation part and a dose expansion part. The dose-escalation study will be performed to evaluate the safety, tolerability, PK profile, immunogenicity, and efficacy of HS-20117 combination therapies in participants with advanced solid tumor. The subsequent dose-expansion study will be performed to evaluate the efficacy of HS-20117 combination therapies in participants with locally advanced or metastatic NSCLC harboring EGFR exon 20 insertion mutations or EGFR classical mutations, and RAS/BRAF V600E wild type CRC.
Eligibility
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.