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
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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:
1. Any anticancer therapy targeting MET, including TKIs, antibodies or antibody-drug conjugates.
2. Monoclonalor bispecific antibodies targeting EGFR.
3. Systemic anti-cancer treatment (Cytotoxicities and anti-cancer Traditional Chinese medicine or TKIs) within 2 weeks prior to the first dose of HS-20117.
4. Investigational anti-cancer drugs or antibodies or ADCs within 4 weeks prior to the first dose of HS-20117.
5. 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.
6. Presence of pleural effusion/ascites requiring clinical intervention; presence of pericardial effusion.
7. 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.
Primary outcome measure(s)
Incidence and severity of treatment-emergent adverse events — rom the date of first dose to 90 days after the final dose. Adverse event (assessed according to NCI CTCAE v5.0) is defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Tolerability of HS-20117 combination therapy: incidence of DLT events, maximum tolerated dose (MTD) or maximum applicable dose (MAD) of HS-20117 in combination therapies. — From the date of first dose to day 21. MTD is defined as the previous dose level at which 2 or more out of 2-6 subjects experienced a DLT. MAD is defined as follows: a) based on PK data, it is anticipated that at this dose level, the dose-exposure plateau has been reached, b) based on existing safety data, it is judged that dose escalation following this dose level will have a large safety risk or subject intolerance, or c) based on the PK-PD model, it suggested that the optimal target concentration of safety and efficacy has been explored.
Trial sites (1)
Facility
City
Region
Status
Tianjin Medical University Cancer Institute & Hospital
Tianjin
China
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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