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;
Single group
HX044
DrugConventional dose-escalation design with 3+3 cohort size. All administered on a Q3 weekly basis. Dose escalation will be based on the absence of DLTs during the 21-day DLT evaluation after a review of safety data by the Safety Review Escalation Committee. Subjects will continue on study treatment until the subject develops an intolerable toxicity, withdraws consent, develops progression of disease, death, lost to follow-up, start of new anticancer treatment or up to study treatment duration of 24 months, whichever comes first.
Number of participants experiencing Adverse Events (AEs)
An AE is any untoward medical occurence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Number of Participants With Dose-Limiting Toxicities(DLT) of HX044
All AEs/toxicities will be graded using the National Cancer Institute Common Terminology Criteria for Adverse Events,Vesion5.0(NCI CTCAE v5.0);For the purpose of dose escalation, any of the following AEs occurring during the DLT observation period that were attributable to one or both study drugs were classified as DLTs.
Objective response rate (ORR) per Investigator Assessment Using RECIST 1.1 and iRECIST
Objective response rate (ORR) ,using RECIST 1.1 and iRECIST criteria, is defined as the proportion of subjects with best overall response of complete response(CR)/iCR or partial response(PR)/iPR after treatment.
Disease control rate(DCR) per Investigator Assessment Using RECIST 1.1 and iRECIST
Disease control rate(DCR) ,using RECIST 1.1 and iRECIST criteria, is defined as the proportion of subjects with best overall response of complete response(CR)/iCR or partial response(PR)/iPR or disease stabilization(SD)/iSD after treatment.
Number of participants with positive Anti-Drug Antibody(ADA) of HX044
ADA blood samples are assayed for anti-HX044 antibodies.
Time of Cmax(Tamx) of HX044
Time to reach HX044 maximum observed serum concentration
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