This is the 'first-in-human' clinical trial of the Investigational Medicinal Product (IMP), Tablet formulation for Oral dosing of MSP008-22, a molecule (new chemical entity) with anticancer properties.
This Single Ascending Dose (SAD) clinical trial is designed to evaluate the safety and tolerability of single oral ascending doses of the IMP in patients with Stage IV of advanced solid tumours including but not limited to Breast cancer including Triple-negative breast cancer, Ovarian cancer, Prostate cancer, Head and Neck squamous cell cancer). The trial will also assess the pharmacokinetic (PK) profile of MSP008-22 in humans. The safety, tolerability and PK data from this trial will determine the safety of MSP008-22 for dosing in humans in further clinical trials. As MSP008-22 has shown efficacy in in vitro studies against various cancer cell lines and in prostate and breast cancer cell lines in xenograft studies, the first in human trial of MSP008-22 is planned in patients of 'Stage-IV of Advanced Solid Tumours (Breast cancer including Triple-negative breast cancer, Ovarian cancer, Prostate cancer, Head and Neck squamous cell cancer and other advanced solid tumors).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
7
It is single group assignment interventional model in this clinical trial, consisting of 5 cohorts of 3 patients in each, to be enrolled such that there exists an overall gender balance for the entire trial and to also ensure including minimum five (5) patients of TNBC and minimum five (5) male patients. The trial will be initiated with dosing of a cohort of 03 patient with the Safe starting dose for MSP008-22. Dosing of the patients for the next higher dose cohort will initiate only after: (i) All 03 patients have been recruited in the lower dose Cohort and if a repeat Cohort at this dose level is recommended, another 03 patients have been recruited at same dose level (ii) all dosed patients have completed the allocated study cohort duration, (iii) safety and pharmacokinetic results have been reviewed by the Independent Dose Escalation Committee (DEC) and approved for dose escalation to next cohort.
Advanced Centre for Treatment, Research and Education in Cancer (ACTREC) of TATA Memorial Centre
Navi Mumbai, Maharashtra, India
Maximum Tolerated Dose (MTD)
to assess Tolerability of MSP008-22 in Human
Time frame: 10 days post dose
Incidence of dose-limiting toxicities (DLTs)
to assess Safety of MSP008-22 in Human
Time frame: 10 days post-dose
Incidence of Treatment Emergent adverse events (TEAE); % of patients who experience at least 1 Treatment Emergent Adverse Event (TEAE); % of patients who discontinue due to TEAE(s).
to assess Safety of MSP008-22 in Human
Time frame: 30 days post-dose
Plasma Cmax
(maximum measured concentration of MSP008-22 in plasma)
Time frame: 72 hours post dose
Plasma AUClast
(area under the plasma concentration time curve of MSP008-22 from hour 0 to last sample with measurable plasma concentrations)
Time frame: 72 hours post dose
Plasma AUCinfinity
(area under the concentration-time curve of MSP008-22 in plasma over the time interval from 0 extrapolated to infinity)
Time frame: 72 hours post dose
plasma tmax
(time from dosing to maximum measured concentration of MSP008-22 in plasma)
Time frame: 72 hours post dose
Plasma t1/2
(terminal half-life of MSP008-22 in plasma)
Time frame: 72 hours post dose
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CL/F
(total clearance of MSP008-22 in plasma after administration estimated using formula)
Time frame: 72 hours post dose
Vz/F
(apparent volume of distribution of MSP008-22 during the terminal phase following administration, estimated using formula)
Time frame: 72 hours post dose
Ae
(the total amount of MSP008-22 excreted in urine)
Time frame: 72 hours post dose
Ae %dose
(the percent of MSP008-22 recovered in urine)
Time frame: 72 hours post dose
CLr
(and the apparent renal clearance of MSP008-22)
Time frame: 72 hours post dose