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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
ISM3412 will be administered orally once daily.
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, United States
RECRUITINGSmilow Cancer Hospital at Yale New Haven Breast Center
New Haven, Connecticut, United States
RECRUITINGIncidence 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
Maximum observed concentration (Cmax)
To assess PK of ISM3412 in plasma following a single and multiple doses of ISM3412
Time frame: Approximately 30 months
Time of maximum observed concentration (Tmax)
To assess PK of ISM3412 in plasma following a single and multiple doses of ISM3412
Time frame: Approximately 30 months
Area under the concentration-time curve (AUC)
To assess PK of ISM3412 in plasma following a single and multiple doses of ISM3412
Time frame: Approximately 30 months
Terminal half-life (t1/2)
To assess PK of ISM3412 in plasma following a single and multiple doses of ISM3412
Time frame: Approximately 30 months
Objective response rate (ORR)
To evaluate the preliminary efficacy of ISM3412 in participants with locally advanced/metastatic solid tumors.
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Community Cancer Center North
Indianapolis, Indiana, United States
RECRUITINGSCRI Oncology Partners
Nashville, Tennessee, United States
RECRUITINGThe University of Texas MD Anderson Cancer Center
Houston, Texas, United States
RECRUITINGCancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
RECRUITINGSun Yat-sen university cancer center
Guangzhou, Guangdong, China
RECRUITINGJiangsu Provincial People's Hospital
Nanjing, Jiangsu, China
RECRUITINGShanghai Gobroad Cancer Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGTime frame: Approximately 30 months
Best objective response (BOR)
To evaluate the preliminary efficacy of ISM3412 in participants with locally advanced/metastatic solid tumors.
Time frame: Approximately 30 months
Duration of response (DoR)
To evaluate the preliminary efficacy of ISM3412 in participants with locally advanced/metastatic solid tumors.
Time frame: Approximately 30 months