The study will consist of a dose-escalation and dose-expansion component to establish the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D), and to evaluate the preliminary antitumor activity of HX044.
HX044 is an investigational drug that has not yet been approved by the Food and Drug Administration (FDA) or any other regulatory authorities for commercial purposes. This is the first study in which HX044 will be given to humans. The study drug has been tested in animals and was found to be well-tolerated with minimal side effects.
Subjects must voluntarily agree to participate by providing written informed consent and agreeing to comply with protocol and scheduled visit;
Male or female subject aged 18-75 years, inclusive;
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
Histologically confirmed advanced malignant solid tumor that is refractory/relapsed to standard therapies, or for which no effective standard therapy is available, or the subject refuses standard therapy.
Prior malignancy active within the previous 5 years except for the tumor for which a subject is enrolled in the study and locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix or breast.
Receipt of any anticancer (chemotherapy, radiation therapy, investigational drugs including small molecular inhibitors, endocrine therapy, immunotherapy) therapy within 4 weeks prior to the first dose of study treatment or 5 half-lives of the therapy, whichever is shorter.
QT/QTc interval prolongation (using Fredericia's QT correction formula) at baseline, Female > 470 ms, Male > 450 ms;
Medications to prolong the QT/QTc interval are currently being taken;