Phase Ib Trial of HS-20117 in Combination With Other Drugs in Advanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHansoh BioMedical R&D Company
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Sequential
Treatments tested in this trial
HS-20117 combined HS-20093
DrugHS-20117 + HS-20093
HS-20117 combined Platinum-containing chemotherapy
DrugHS-20117 + cisplatin/carboplatin + pemetrexed
HS-20117 combined HS-20093 and 5-FU
DrugHS-20117 + HS-20093 + 5-FU
HS-20117+CAPEOX
DrugCAPOEX: Oxaliplatin+Capecitabine
HS-20117+FOLFIRI
DrugFOLFIRI=Irinotecan+Leucovorin Calcium+5-FU
HS-20117+mFOLFOX6
DrugmFOLFOX6=Oxaliplatin+Leucovorin Calcium+5-FU
Treatment groups
780 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Cohort 1aExperimental treatment 1 intervention
Group B: Cohort 2aExperimental treatment 1 intervention
Group C: Cohort 3aExperimental treatment 1 intervention
Group D: Cohort 4aExperimental treatment 1 intervention
Group E: Cohort 5aExperimental treatment 1 intervention
Group F: Cohort 6aExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence and severity of treatment-emergent adverse events
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.
Time frame
rom the date of first dose to 90 days after the final dose.2
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.
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.
Time frame
From the date of first dose to day 21.Secondary outcomes
1
Efficacy of HS-20117: Objective response rate (ORR)
ORR is defined as the percentage of participants with BOR of confirmed CR or confirmed PR per RECIST v1.1
Time frame
From the date of first dose to the date of disease progression or withdrawal from study, approximately 2 years2
Efficacy of HS-20117: disease control rate (DCR)
DCR is defined as the percentage of patients who have a best overall response (confirmed CR, PR, or stable disease for at least 6 weeks) per RECIST v1.1.
Time frame
From the date of first dose to the date of disease progression or withdrawal from study, approximately 2 years3
Efficacy of HS-20117: duration of response (DoR)
DoR only applies to participants whose best overall response is CR or PR based on assessment per RECIST v1.1. The start date is the date of first documented response of CR or PR (i.e. the start date of observed response, not the date when response was confirmed), and the end date is defined as the date of the first documented progression or death due to underlying disease.
Time frame
From the date of first dose to the date of disease progression or withdrawal from study, approximately 2 years4
Efficacy of HS-20117: progression free survival (PFS)
PFS is defined as the time from the date of randomization or first dose (if randomization is not needed) to the date of the first documented progression or death due to any cause. PFS will be assessed per RECIST v1.1.
Time frame
From the date of first dose to the date of disease progression or withdrawal from study, approximately 2 yearsSponsors and contacts
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Source ClinicalTrials.gov