Status and phase
Conditions
Treatments
About
Phase 1 is an open-label, multi-center dose escalation/dose expansion study designed to assess the safety, tolerability and pharmacokinetics (PK) for the recommended phase 2 dose (RP2D) of IMX-110. The RP2D will be evaluated in a further dose expansion Phase 2a study submitted.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Male or female patients who are 18 years or older
Patients with confirmed advanced solid tumor as per histology, who have progressed, are refractory, or are intolerant to standard therapy appropriate for tumor type
Patients with an Eastern Cooperative Oncology Group (ECOG) Performance status of 0-2 (Appendix 2)
Patients with a life expectancy of at least 3 months
Patients with adequate cardiac function as measured by left ventricular ejection fraction >50%
Patients who meet the following laboratory requirements:
Women of childbearing potential and men must agree to use highly effective, double barrier contraception during the study and for 6 weeks following the final dose of IMX-110. Double barrier contraception is defined as a condom AND one other form of the following:
Male patients must not donate sperm for at least 24 weeks post-dose of the last study treatment. Male partners of female patients and female partners of male patients must also use contraception, if they are of childbearing potential.
Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day -1.
Rhythm methods during the study and for 6 weeks after the dose of IMX-110 will not be acceptable.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
70 participants in 1 patient group
Loading...
Central trial contact
Ilya Rachman, MD
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal