This first-in-human study will evaluate the Maximum Tolerated Dose (MTD) / the Recommended Phase 2 Dose (RP2D), safety, tolerability, anti-tumor activity, pharmacokinetics, pharmacodynamics and immunogenicity of AMT-151, a novel antibody-drug conjugate against folate receptor alpha, in patients with selected advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Administered intravenously
Chris O'Brien Lifehouse
Sydney, New South Wales, Australia
RECRUITINGICON Cancer Centre
Brisbane, Queensland, Australia
RECRUITINGMater Cancer Care Centre
South Brisbane, Queensland, Australia
RECRUITINGCancer Research SA
Adelaide, South Australia, Australia
RECRUITINGCabrini Malvern Hospital
Malvern, Victoria, Australia
RECRUITINGOne Clinical Research (OCR)
Perth, Western Australia, Australia
RECRUITINGFujian Provincial Cancer Hospital
Fuzhou, Fujian, China
NOT_YET_RECRUITINGHunan Cancer Hospital
Changsha, Hunan, China
NOT_YET_RECRUITINGShanghai Tumor Hospital
Shanghai, Shanghai Municipality, China
NOT_YET_RECRUITINGRecommended Phase 2 Dose (RP2D)
The RP2D will be determined using dose limiting toxicities (DLTs) and all other available study data
Time frame: Up to 24 months
Maximum Tolerated Dose (MTD)
The MTD will be determined using DLTs
Time frame: Up to 24 months
Incidence of Adverse Events
Safety and tolerability profile assessed by the Common Terminology Criteria for Adverse Events v5.0
Time frame: Up to 24 months
Overall Response Rate (ORR) according to the Response Evaluation Criteria in Solid Tumours (RECIST) v1.1
Proportion of patients achieving Complete Response (CR) or Partial Response (PR)
Time frame: Up to 24 months
Disease Control Rate (DCR) according to the RECIST v1.1
Proportion of patients achieving CR, PR or Stable Disease (SD)
Time frame: Up to 24 months
Progression-free Survival (PFS)
Time from date of start of treatment to date of the first progression or death, whichever occurs first.
Time frame: Up to 24 months
Time to Treatment Response (TTR)
Time from date of start of treatment to date of the first assessment of response (PR or CR)
Time frame: Up to 24 months
Duration of Response (DoR)
Time from date of first assessment of response (CR or PR) to date of the first progression or death, whichever occurs first
Time frame: Up to 24 months
Overall Survival (OS)
Time from date of start of treatment to date of death
Time frame: Up to 24 months
Concentration of anti-drug antibodies (ADA)
Immunogenicity profile characterized by concentration of ADAs
Time frame: Up to 24 months
Maximum observed concentration (C[max])
Pharmacokinetic profile characterized by the maximum observed concentration (C\[max\]) of AMT-151
Time frame: Up to 24 months
Area under the curve (AUC)
Pharmacokinetic profile characterized by the area under the curve (AUC) of AMT-151
Time frame: Up to 24 months
Terminal half-life (t[1/2])
Pharmacokinetic profile characterized by the terminal half-life (t\[1/2\]) of AMT-151
Time frame: Up to 24 months
Time to maximum concentration (Tmax)
Pharmacokinetic profile characterized by the time to maximum concentration (Tmax) of AMT-151
Time frame: Up to 24 months
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