This is a 2-part, first-in-human, open-label study to determine the safety and tolerability of KIVU-107, a PTK7-directed antibody-drug conjugate, in participants with locally advanced or metastatic solid tumors.
Part A: The primary objective of Part A of this study is to evaluate the safety and tolerability of KIVU-107 and to determine the maximum tolerated dose (MTD)/Recommended Dose for Expansion (RDE). Part B: The primary objective of Part B of this study is to confirm the safety and tolerability of KIVU-107 at the RDE.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
76
KIVU-107 will be administered IV.
Kivu Trial Site
Sydney, New South Wales, Australia
RECRUITINGKivu Trial Site
Brisbane, Queensland, Australia
RECRUITINGKivu Trial Site
Adelaide, South Australia, Australia
RECRUITINGPart A (Dose Finding): To determine the Maximum Tolerated Dose (MTD)
Number of participants with treatment emergent adverse events
Time frame: Up to 18 months
Number of participants with treatment related adverse events as assessed by CTCAE version 5.0
Time frame: Up to 18 months
To evaluate safety and tolerability of KIVU-107
Number of participants with treatment related adverse events as assessed by CTCAE v5.0
Time frame: Up to 30 months
Objective Response Rate (ORR) is percentage of participants with best response of complete response (CR) or partial response (PR) according to RECIST 1.1
Time frame: Up to 30 months
Duration of Response (DOR)
Time from CR or PR to objective disease progression or death to any cause
Time frame: Up to 30 months
To evaluate the immunogenicity as measured by change of anti-drug antibodies in participants treated with KIVU-107
Time frame: Up to 30 months
Maximum Serum concentration of KIVU-107 (Cmax)
PK assessment
Time frame: 21 days
Maximum serum concentration of KIVU-107 (Cmin)
PK assessment
Time frame: 21 days
Maximum Serum concentration of KIVU-107 at Steady State (Cmax, ss)
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PK assessment
Time frame: up to 168 days
Minimum Serum Concentration of KIVU-107 at Steady State (Cmin, ss)
PK assessment
Time frame: up to 168 days
Time of Maximum Serum Concentration of KIVU-107 (Tmax)
PK assessment
Time frame: up to 168 days
Time of Minimum Serum Concentration of KIVU-107 (Tmin)
PK assessment
Time frame: up to 168 days
Time of Minimum Serum Concentration of KIVU-107 (Tmin, ss)
PK assessment
Time frame: Up to 168 days
Terminal Half-Life (t1/2) of Serum KIVU-107
PK assessment
Time frame: Up to 168 days
Area under the Serum Concentration-Time curve from the time of dosing to the last measurable concentration (AUClast) for KIVU-107
PK Assessment
Time frame: 21 days
Area under the Serum Concentration-Time curve from the time of dosing extrapolated to time infinity (AUCinf) for KIVU-107
PK Assessment
Time frame: Up to 168 days
Clearance (CL) of KIVU-107
PK Assessment
Time frame: Up to 168 days
Apparent volume of distribution during the terminal phase (Vz) of KIVU-107
PK Assessment
Time frame: Up to 168 days
Accumulation ration (Rac) of KIVU-107
PK Assessment
Time frame: Up to 168 days