This is a phase I, two-part, multicenter, first-in-human study. The Part 1 study will assess the safety, tolerability, preliminary anti-tumor activities, PK profile, immunogenicity and biomarker of GenSci139 in participants with locally advanced or metastatic solid tumors, as well as identity MTD (if any) and RDE. The Part 2 study is to further evaluate the preliminary anti-tumor activities, safety, PK profile, immunogenicity and biomarker of GenSci139 at RDE dose levels with selected advanced cancers.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
280
GenSci139 is a bispecific antibody drug conjugate targeting EGFR and HER2.
Shandong First Medical University Affiliated Cancer Hospital
Jinan, Shandong, China
RECRUITINGPart 1 and Part2: Incidence of adverse events
Percentage of patients with adverse events by system organ class and preferred term
Time frame: From time of informed consent to 30 days post last dose of GenSci139
Dose limiting toxicities (DLTs)
DLTs are assessed during the DLT observation period and defined as any toxicity in DLT definition in the Clinical Study Protocol
Time frame: from time of first dose of GenSci139 to end of DLT observation period(approximately 21 days)
Part1: Maximum Tolerated Dose (MTD) and Recommended Doses for Expansion (RDEs)
To determine the maximum tolerated dose (MTD), if any, and recommend dose of expansion (RDE) for GenSci139
Time frame: from time of first dose of GenSci139 up to 18 months
Part2: Objective response rate(ORR)
To evaluate the preliminary anti-tumor activities of GenSci139 as measured by ORR using RECIST criteria v1.1.
Time frame: approximately 12 months
Part2: disease control rate (DCR)
To evaluate the preliminary anti-tumor activities of GenSci139 as measured by DCR using RECIST criteria v1.1.
Time frame: approximately 12 months
Part2: Duration of response (DoR)
To evaluate the preliminary anti-tumor activities of GenSci139 as measured by DoR using RECIST criteria 1.1.
Time frame: approximately 24 months
Cmax of GenSci139
Calculate maximum observed concentration of GenSci139
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: approximately 24 months
Part1: Cmax of total antibody
Calculate maximum observed concentration of total antibody
Time frame: approximately 24 months
Part1: Cmax of free payload
Calculate maximum observed concentration of free payload
Time frame: approximately 24 months
Part1: Tmax of GenSci139
Calculate time of maximum observed concentration of GenSci139
Time frame: approximately 24 months
Part1: Tmax of total antibody
Calculate time of maximum observed concentration of total antibody
Time frame: approximately 24 months
Part1: Tmax of free payload
Calculate time of maximum observed concentration of free payload
Time frame: approximately 24 months
Part1: AUC of GenSci139
Calculate area under the curve of GenSci139
Time frame: approximately 24 months
Part1: AUC of total antibody
Calculate area under the curve of total antibody
Time frame: approximately 24 months
Part1: AUC of free payload
Calculate area under the curve of free payload
Time frame: approximately 24 months
Part1: Objective response rate(ORR)
To evaluate the preliminary anti-tumor activities of GenSci139 as measured by ORR using RECIST criteria v1.1.
Time frame: approximately 12 months
Part1: disease control rate (DCR)
To evaluate the preliminary anti-tumor activities of GenSci139 as measured by DCR using RECIST criteria v1.1.
Time frame: approximately 12 months
Part1: Duration of response (DoR)
To evaluate the preliminary anti-tumor activities of GenSci139 as measured by DoR using RECIST criteria 1.1.
Time frame: approximately 24 months
Part1: ADA of GenSci139
Incidence and titer of anti-drug antibody (ADA)
Time frame: approximately 24 months
Part1: NAb of GenSci139
Incidence and titer of neutralizing antibody (NAb)
Time frame: approximately 24 months
Part2: Cmax of GenSci139
Calculate maximum observed concentration of GenSci139
Time frame: approximately 24 months
Part2: Cmax of total antibody
Calculate maximum observed concentration of total antibody
Time frame: approximately 24 months
Part2: Cmax of free payload
Calculate maximum observed concentration of free payload
Time frame: approximately 24 months
Part2: Tmax of GenSci139
Calculate time of maximum observed concentration of GenSci139
Time frame: approximately 24 months
Part2: Tmax of total antibody
Calculate time of maximum observed concentration of total antibody
Time frame: approximately 24 months
Part2: Tmax of free payload
Calculate time of maximum observed concentration of free payload
Time frame: approximately 24 months
Part2: AUC of GenSci139
Calculate area under the curve of GenSci139
Time frame: approximately 24 months
Part2: AUC of total antibody
Calculate area under the curve of total antibody
Time frame: approximately 24 months
Part2: AUC of free payload
Calculate area under the curve of free payload
Time frame: approximately 24 months
Part2: ADA of GenSci139
Incidence and titer of anti-drug antibody (ADA)
Time frame: approximately 24 months
Part2: NAb of GenSci139
Incidence and titer of neutralizing antibody (NAb)
Time frame: approximately 24 months