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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Have a histological diagnosis of metastatic or locally advanced inoperable NET, NEC, or other solid tumors that have confirmed radiological progression.
* Have one or more measurable disease location per RECIST version 1.1.
* Have a tumor that expresses SSR confirmed by SSR imaging.
* Have an ECOG performance status of 0, 1, or 2.
Exclusion Criteria:
* Have tumor progression while undergoing a course of PRRT or within 6 months of completing PRRT.
* Have brain metastases unless asymptomatic and stable for at least one month for participants with SCLC or LCLC or at least 3 months for participants with other non-NET solid tumors.
* Use of anticancer agents within specified intervals prior to the first dose of study drug.
* Had surgery, chemoembolization, or radiofrequency ablation within 90 days prior to first dose of study drug.
* Prior participation in any intervention clinical study within 30 days or 5 half-lives (whichever is longer) prior to the first dose of study drug.
* Participants with carcinoid syndrome.
* Secondary malignancy: participants who have any other malignancy known to be active or treated within 3 years of the start of screening, with the exception of treated cervical intraepithelial neoplasia, superficial (noninvasive) bladder cancer, and non-melanoma skin cancer.
* Have prior treatment with MMAE.
* Have hypersensitivity or history of anaphylactic reaction to octreotide, other SSAs, and/or MMAE.
Primary outcome measure(s)
(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.
Trial sites (27)
Facility
City
Region
Status
Crinetics Study Site
Phoenix
Arizona
Recruiting
Crinetics Study Site
Duarte
California
Recruiting
Crinetics Study Site
Newport Beach
California
Recruiting
Crinetics Study Site
Orange
California
Recruiting
Crinetics Study Site
San Francisco
California
Recruiting
Crinetics Study Site
Aurora
Colorado
Recruiting
Crinetics Study Site
Denver
Colorado
Recruiting
Crinetics Study Site
New Haven
Connecticut
Recruiting
Crinetics Study Site
Atlanta
Georgia
Recruiting
Crinetics Study Site
Lexington
Kentucky
Recruiting
Crinetics Study Site
Metairie
Louisiana
Recruiting
Crinetics Study Site
Detroit
Michigan
Recruiting
Crinetics Study Site
Grand Rapids
Michigan
Recruiting
Crinetics Study Site
Rochester
Minnesota
Recruiting
Crinetics Study Site
New York
New York
Recruiting
Crinetics Study Site
Philadelphia
Pennsylvania
Recruiting
Crinetics Study Site
Philadelphia
Pennsylvania
Recruiting
Crinetics Study Site
Austin
Texas
Recruiting
Crinetics Study Site
Houston
Texas
Recruiting
Crinetics Study Site
Irving
Texas
Recruiting
Crinetics Study Site
Salt Lake City
Utah
Recruiting
Crinetics Study Site
Charlottesville
Virginia
Recruiting
Crinetics Study Site
Fairfax
Virginia
Recruiting
Crinetics Study Site
Barcelona
Spain
Recruiting
Crinetics Study Site
Barcelona
Spain
Recruiting
Crinetics Study Site
Madrid
Spain
Recruiting
Crinetics Study Site
Madrid
Spain
Recruiting
More Crinetics Pharmaceuticals Inc. trials in the USA
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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