MSP008-22 is a novel molecule with anticancer effects demonstrated in in-vitro and in-vivo animal studies. Specifically, MSP008-22 has shown efficacy in the breast cancer and prostate cancer cell lines. Safety of MSP008-22 has been tested in in-vitro studies, preclinical single dose and repeat dose studies in animals, as well as safety pharmacology studies in animals and it was found to be safe up to the dose of 2000 mg/ kg body weight. Safety Pharmacology studies of MSP008-22 are completed for cardiovascular, respiratory, and central nervous systems and was found to be safe. The molecule did not exhibit the required level of cytotoxicity at any of tested concentration both in presence and absence of metabolic activation with 3-hour exposure and at also in the absence of metabolic activation with 22- hour exposure at and upto 424 µg/mL in in-vitro chromosomal aberration test performed using cultured human peripheral blood lymphocytes. The No Observable Effect Level (NOEL) for MSP008- 22 was 1000 mg/ kg body weight for Sprague Dawley rats. The current study “A single arm, open label, multi-centric, dose-ranging, single ascending dose, first-inhuman, phase I trial to assess safety, tolerability, and pharmacokinetic profile of MSP008- 22 in patients with Stage IV of advanced solid tumors (ovarian cancer, breast cancer including Triple-negative breast cancer, head and neck squamous cell cancer)”, is a First-in-Human trial with the primary objective to understand the safety and tolerability of the investigational medicinal product in humans and secondary objective being estimation of the pharmacokinetic profile of the MSP008-22 in humans after a single oral