This Phase 1/2, multicenter, open-label, FIH study aims to evaluate the safety, tolerability, PK, and preliminary antitumor activity of CRN09682 in participants with SST2-expressing NENs and other solid tumors. The study includes a Dose Escalation Phase to determine the MTD and DLTs. Following MTD identification, additional participants will be enrolled at the expansion dose to further assess safety, tolerability, PK, and antitumor activity.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Study drug CRN09682 intravenously
Crinetics Study Site
Duarte, California, United States
RECRUITINGCrinetics Study Site
Newport Beach, California, United States
RECRUITINGCrinetics Study Site
Denver, Colorado, United States
RECRUITINGCrinetics Study Site
New Haven, Connecticut, United States
RECRUITINGCrinetics Study Site
Atlanta, Georgia, United States
RECRUITINGCrinetics Study Site
Lexington, Kentucky, United States
RECRUITINGCrinetics Study Site
Metairie, Louisiana, United States
RECRUITINGCrinetics Study Site
Grand Rapids, Michigan, United States
RECRUITINGCrinetics Study Site
Philadelphia, Pennsylvania, United States
RECRUITINGCrinetics Study Site
Austin, Texas, United States
RECRUITING...and 7 more locations
(Dose Escalation) Incidence and severity of DLTs.
Time frame: From first dose through Day 21.
(Dose Escalation) Incidence and severity of AEs and SAEs at each dose level and incidence of AEs leading to discontinuation from study drug.
Time frame: From first dose of study drug to 30 days after the last dose.
(Dose Expansion) Nature, incidence, and severity of AEs and SAEs at the Expansion Dose.
Time frame: From first dose of study drug to 30 days after the last dose.
(Dose Expansion) Interruptions at the Expansion Dose.
Time frame: At Day 1 of each cycle through study completion, approximately 2 years.
(Dose Escalation) Maximum Plasma Concentration (Cmax) of CRN09682 and MMAE .
Time frame: Day 1 of each cycle (each cycle is 21 days) for the duration of the study, from baseline to safety follow-up visit, up to 2 years.
(Dose Escalation) Time to Maximum Concentration (Tmax) of CRN09682 and MMAE.
Time frame: Day 1 of each cycle (each cycle is 21 days) for the duration of the study, from baseline to safety follow-up visit, up to 2 years.
(Dose Escalation) Measure of CRN09682 and MMAE exposure in the body from initial dose to the last measurable concentration (AUC0-last).
Time frame: Day 1 of each cycle (each cycle is 21 days) for the duration of the study, from baseline to safety follow-up visit, up to 2 years.
(Dose Escalation) Measure of total CRN09682 exposure in the body across time (AUC0-inf).
Time frame: Day 1 of each cycle (each cycle is 21 days) for the duration of the study, from baseline to safety follow-up visit, up to 2 years.
(Dose Escalation) The amount of time required for CRN09682 to be reduced to half of its initial concentration in the blood (t1/2).
Time frame: Day 1 of each cycle (each cycle is 21 days) for the duration of the study, from baseline to safety follow-up visit, up to 2 years.
(Dose Escalation & Expansion) Objective response rate (ORR): The percentage of patients with best overall response of complete response or partial response according to RECIST 1.1
Time frame: Throughout the study until disease progression or the last evaluable assessment in the absence of progression whichever occurs first, approximately 2 years.
(Dose Escalation & Expansion) Disease control rate (DCR): The percentage of patients with best overall response of complete response, partial response, or stable disease according to RECIST 1.1
Time frame: Throughout the study until disease progression or the last evaluable assessment in the absence of progression whichever occurs first , approximately 2 years.
(Dose Escalation & Expansion) Duration of response (DOR): The time from the date of first objective response until date of disease progression or death in the absence of disease progression, according to RECIST 1.1.
Time frame: From the first documented objective response to disease progression or death whichever occurs first, approximately 2 years.
(Dose Expansion) Changes in somatostatin receptor imaging: Evaluate changes in SSR tracer uptake over time, based on whether uptake is greater than or less than liver uptake.
Time frame: Throughout the study at predefined intervals, approximately 2 years.
(Dose Expansion) Radiographic PFS: The time from the start of study drug until RECIST 1.1 defined disease progression or death in the absence of disease progression.
Time frame: Throughout the study until disease progression or death whichever occurs first, approximately 2 years.
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