Locally Advanced Solid Tumors, Metastatic Solid Tumors
Conditions
Keywords
Locally Advanced, Metastatic, Solid Tumor
Brief summary
RX108 is a novel, potent, small-molecule inhibitor of Na+/K+-ATPase. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and efficacy of RX108 in patients with locally advanced or metastatic solid tumors.
Detailed description
This is a open-label, two-part study comprised of a dose escalation part and a dose expansion part. In the dose escalation part, RX108 will be administered in ascending doses to evaluate the safety and tolerability of RX108 and determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D). The dose expansion part will assess the safety, pharmacokinetics, and efficacy of RX108 at the RP2D.
Interventions
DRUGRX108
RX108
Sponsors
NeuPharma, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed locally advanced or metastatic cancer that has failed all systemic therapies known to confer clinical benefit * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Minimum age of 18 years * Adequate hematologic, hepatic and renal function * Written Informed Consent * Must agree to use adequate contraception (females and males)
Exclusion criteria
* History of certain cardiac abnormalities * History of inadequate pulmonary function * Symptomatic brain metastasis * Treatment with prohibited medications * Known contra-indication to digoxin * Treatment with any unapproved therapies for cancer, or any other anti-cancer therapy within 3 weeks * Any toxicity related to prior treatment must have resolved to Grade 1 or less, with the exception of alopecia * Clinically significant active infection requiring systemic antibiotic treatment * Females who are pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part 1: Maximum tolerated dose (MTD) of RX108 | Day 1 to 30 | All patients treated with RX108 across all dosing levels will have safety assessed in order to determine the MTD. |
| Part 2: Incidence of adverse events (AEs) and serious adverse events (SAEs). | Day 1 to 30 days post last dose | The incidence of adverse events (AEs) and serious adverse events (SAEs) for each cohort dose will be assessed using CTCAE v 5.0. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area under the plasma concentration-time curve (AUC) | Day 1 and Day 3: Hours 0, 1, 2, 3, 5, 8 | Pharmacokinetics parameter |
| Elimination half-life (T1/2) | Day 1 and Day 3: Hours 0, 1, 2, 3, 5, 8 | Pharmacokinetics parameter |
| Maximum observed plasma concentration (Cmax) of RX108 | Day 1 and Day 3: Hours 0, 1, 2, 3, 5, 8 | Pharmacokinetics parameter |
| Response rate (per RECIST v1.1) | Screening and every 2 cycles for the first 6 cycles and every 3 cycles thereafter (each cycle is 28 days), assessed up to 24 months. | Evaluate the preliminary efficacy of RX108 in subjects with locally advanced or metastatic solid tumors (subjects with measurable disease in Part 2). |
| Systemic clearance (CL) | Day 1 and Day 3: Hours 0, 1, 2, 3, 5, 8 | Pharmacokinetics parameter |
| Time to reach maximum concentration (Tmax) | Day 1 and Day 3: Hours 0, 1, 2, 3, 5, 8 | Pharmacokinetics parameter |
Countries
United States
Contacts
Primary ContactLyon Gleich, MD
Outcome results
None listed