A first-in-human study using HKT288 in solid tumors, including epithelial ovarian cancer and renal cell carcinoma
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Cadherin-6-targeting antibody-drug conjugate for intravenous administration
Novartis Investigative Site
Houston, Texas, United States
Novartis Investigative Site
Melbourne, Victoria, Australia
Novartis Investigative Site
Leuven, Belgium
Novartis Investigative Site
Nagoya, Aichi-ken, Japan
Incidence of dose limiting toxicities (DLTs) in the DLT evaluation period
Time frame: evaluation period is 21 days
Safety assessed by overall incidence of adverse events (AEs) and serious adverse events (SAEs)
Time frame: Until 105 days after last dose of study treatment (=average of approximately 6 months after first dose)
Tolerability as assessed by numbers of dose changes or interruptions
Time frame: Until last dose of study treatment (=average of approximately 6 months after first dose)
Safety assessed by severity of adverse events (AEs) and serious adverse events (SAEs)
Time frame: Until 105 days after last dose of study treatment (=average of approximately 6 months after first dose)
Concentration vs. time profiles of total antibody (tAb)
Time frame: On treatment up to Cycle 6 Day 1 and at the time of study treatment discontinuation (=average of approximately 6 months after first dose). 1 cycle is 21 days, increases to 28 days if there is a dose delay of 7 days for the start of next dose
Objective response rate
Time frame: every 2 cycles up to Cycle 17 and every 3 cycles thereafter until study treatment discontinuation (=average of approximately 6 months after first dose). Then every 9 weeks until end of disease progression follow-up (up to 12 months)
Duration of response
Time frame: every 2 cycles up to Cycle 17 and every 3 cycles thereafter until study treatment discontinuation (=average of approximately 6 months after first dose). Then every 9 weeks until end of disease progression follow-up (up to 12 months)
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Novartis Investigative Site
Barcelona, Catalonia, Spain
Novartis Investigative Site
Locarno, Switzerland
Progression-free survival
Time frame: every 2 cycles up to Cycle 17 and every 3 cycles thereafter until study treatment discontinuation (=average of approximately 6 months after first dose). Then every 9 weeks until end of disease progression follow-up (up to 12 months)
Disease Control Rate
Time frame: At 6 months on treatment
Best overall response
Time frame: every 2 cycles up to Cycle 17 and every 3 cycles thereafter until study treatment discontinuation (=average of approximately 6 months after first dose). Then every 9 weeks until end of disease progression follow-up (up to 12 months)
Presence of anti-HKT288 antibodies.
Time frame: On treatment up to Cycle 6 Day 1 and at the time of study treatment discontinuation (=average of approximately 6 months after first dose)
CDH6 expression level
Time frame: 3 months
Pharmacokinetics (PK) parameter (AUC) for HKT288
Time frame: On treatment up to Cycle 6 Day 1 and at the time of study treatment discontinuation (=average of approximately 6 months after first dose)
PK parameter (Cmax) for HKT288
Time frame: On treatment up to Cycle 6 Day 1 and at the time of study treatment discontinuation (=average of approximately 6 months after first dose)
PK parameter (Tmax) for HKT288
Time frame: On treatment up to Cycle 6 Day 1 and at the time of study treatment discontinuation (=average of approximately 6 months after first dose)
PK parameters (half-life) for HKT288
Time frame: On treatment up to Cycle 6 Day 1 and at the time of study treatment discontinuation (=average of approximately 6 months after first dose)