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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation | Experimental | Multiple Dose Levels administered Q3W |
|
| Dose Expansion: Cohort 1 | Experimental | Pancreatic Neuroendocrine Tumor (NET) |
|
| Dose Expansion: Cohort 2 | Experimental | Non-Pancreatic NET |
|
| Dose Expansion: Cohort 3 | Experimental | Neuroendocrine Carcinoma (NEC) |
|
| Dose Expansion: Cohort 4 | Experimental | Other Solid Tumors |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CRN09682 | Drug | Study drug CRN09682 intravenously |
|
| Measure | Description | Time Frame |
|---|---|---|
| (Dose Escalation) Incidence and severity of DLTs. | 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. | 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. | From first dose of study drug to 30 days after the last dose. | |
| (Dose Expansion) Interruptions at the Expansion Dose. | At Day 1 of each cycle through study completion, approximately 2 years. |
| Measure | Description | Time Frame |
|---|---|---|
| (Dose Escalation) Maximum Plasma Concentration (Cmax) of CRN09682 and MMAE . | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Contact if you are a potential participant or caregiver | Contact | 833-827-9741 | studyinfo@crinetics.com | |
| Contact if you are an HCP/clinical site staff/other | Contact | 833-827-9741 | clinicalsites@crinetics.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Crinetics Study Site | Recruiting | Phoenix | Arizona | 85054 | United States | |
| Crinetics Study Site |
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This is a Phase 1/2, 2-part, multicenter, open-label, nonrandomized, multiple-dose, first-in-human study (with dose escalation and expansion phase) of CRN09682 in participants with NENs and other solid tumors.
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| 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). | 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). | 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). | 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 | 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 | 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. | 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. | 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. | Throughout the study until disease progression or death whichever occurs first, approximately 2 years. |
| Recruiting |
| Duarte |
| California |
| 91010 |
| United States |
| Crinetics Study Site | Recruiting | Newport Beach | California | 92663 | United States |
| Crinetics Study Site | Recruiting | Orange | California | 92868 | United States |
| Crinetics Study Site | Recruiting | San Francisco | California | 60637 | United States |
| Crinetics Study Site | Recruiting | Denver | Colorado | 80218 | United States |
| Crinetics Study Site | Recruiting | New Haven | Connecticut | 48201 | United States |
| Crinetics Study Site | Recruiting | Atlanta | Georgia | 30322 | United States |
| Crinetics Study Site | Recruiting | Lexington | Kentucky | 40536 | United States |
| Crinetics Study Site | Recruiting | Metairie | Louisiana | 70006 | United States |
| Crinetics Study Site | Recruiting | Detroit | Michigan | 48201 | United States |
| Crinetics Study Site | Recruiting | Grand Rapids | Michigan | 49503 | United States |
| Crinetics Study Site | Recruiting | Rochester | Minnesota | 53905 | United States |
| Crinetics Study Site | Recruiting | New York | New York | 10016 | United States |
| Crinetics Study Site | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
| Crinetics Study Site | Recruiting | Philadelphia | Pennsylvania | 19111 | United States |
| Crinetics Study Site | Recruiting | Austin | Texas | 78758 | United States |
| Crinetics Study Site | Recruiting | Houston | Texas | 70030 | United States |
| Crinetics Study Site | Recruiting | Irving | Texas | 75039 | United States |
| Crinetics Study Site | Recruiting | Salt Lake City | Utah | 84112 | United States |
| Crinetics Study Site | Recruiting | Charlottesville | Virginia | 22908 | United States |
| Crinetics Study Site | Recruiting | Fairfax | Virginia | 22031 | United States |
| Crinetics Study Site | Recruiting | Barcelona | 08023 | Spain |
| Crinetics Study Site | Recruiting | Barcelona | 08035 | Spain |
| Crinetics Study Site | Recruiting | Madrid | 28040 | Spain |
| Crinetics Study Site | Recruiting | Madrid | 28041 | Spain |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D009362 | Neoplasm Metastasis |
| D018278 | Carcinoma, Neuroendocrine |
| ID | Term |
|---|---|
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
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