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NCT07129252PHASE1, PHASE2Recruiting

A Study to Investigate Safety and Effectiveness of CRN09682 in Participants With SST2-Expressing NENs and Other Solid Tumors

Crinetics Pharmaceuticals Inc.

Start Date

11/26/2025

Completion Date

8/1/2029

Summary

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 Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

CRN09682

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Conditions

SST2-positive Neuroendocrine NeoplasmsNeuroendocrine TumorsNeuroendocrine Neoplasm

Locations

Crinetics Study Site

Phoenix, Arizona 85054

United States

Crinetics Study Site

Duarte, California 91010

United States

Crinetics Study Site

Newport Beach, California 92663

United States

Crinetics Study Site

Orange, California 92868

United States

Crinetics Study Site

San Francisco, California 60637

United States

Crinetics Study Site

Aurora, Colorado 80045

United States

Crinetics Study Site

Denver, Colorado 80218

United States

Crinetics Study Site

New Haven, Connecticut 48201

United States

Crinetics Study Site

Atlanta, Georgia 30322

United States

Crinetics Study Site

Lexington, Kentucky 40536

United States

Crinetics Study Site

Metairie, Louisiana 70006

United States

Crinetics Study Site

Detroit, Michigan 48201

United States

Crinetics Study Site

Grand Rapids, Michigan 49503

United States

Crinetics Study Site

Rochester, Minnesota 53905

United States

Crinetics Study Site

New York, New York 10016

United States

Crinetics Study Site

Philadelphia, Pennsylvania 19104

United States

Crinetics Study Site

Philadelphia, Pennsylvania 19111

United States

Crinetics Study Site

Austin, Texas 78758

United States

Crinetics Study Site

Houston, Texas 70030

United States

Crinetics Study Site

Irving, Texas 75039

United States

Crinetics Study Site

Salt Lake City, Utah 84112

United States

Crinetics Study Site

Charlottesville, Virginia 22908

United States

Crinetics Study Site

Fairfax, Virginia 22031

United States

Crinetics Study Site

Barcelona, 08023

Spain

Crinetics Study Site

Barcelona, 08035

Spain

Crinetics Study Site

Madrid, 28040

Spain

Crinetics Study Site

Madrid, 28041

Spain