A Phase 1/2, Open-Label, Multicenter, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics/Pharmacodynamics, and Preliminary Efficacy of ISM3412 in Participants With Locally Advanced/Metastatic Solid Tumors
Summary
The study has consists of two parts, a dose escalation part (Part 1) and a dose selection optimization part (Part 2). The primary objectives of this study are to evaluate the safety and tolerability of ISM3412 in participants with locally advanced/metastatic solid tumors, and to determine the RP2D of ISM3412.
Arms & interventions
- DrugISM3412
ISM3412 will be administered orally once daily.
Outcome measures
Primary
Incidence of dose-limiting toxicity (DLT) events
To evaluate the safety and tolerability of ISM3412.
Time frame: 31 days
Incidence and severity of adverse events (AEs)
To evaluate the safety and tolerability of ISM3412.
Time frame: Approximately 30 months
Recommended phase 2 dose (RP2D)
To determine the RP2D of ISM3412.
Time frame: Approximately 30 months
Secondary
Maximum observed concentration (Cmax)
Time frame: Approximately 30 months
Time of maximum observed concentration (Tmax)
Time frame: Approximately 30 months
Area under the concentration-time curve (AUC)
Time frame: Approximately 30 months
Terminal half-life (t1/2)
Time frame: Approximately 30 months
Objective response rate (ORR)
Time frame: Approximately 30 months
Best objective response (BOR)
Time frame: Approximately 30 months
Duration of response (DoR)
Time frame: Approximately 30 months
Eligibility criteria
Study locations (5)
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, 80218
Smilow Cancer Hospital at Yale New Haven Breast Center
New Haven, Connecticut, 06520-8028
Community Cancer Center North
Indianapolis, Indiana, 46250-2042
SCRI Oncology Partners
Nashville, Tennessee, 37203
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030-4095