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A Study to Investigate Safety and Effectiveness of CRN09682 in Participants With SST2-Expressing NENs and Other Solid Tumors | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

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

A Phase 1/2 Dose Escalation Study of CRN09682 With an Expansion Phase in Participants With Progressive Metastatic Somatostatin Receptor Type 2 (SST2)-Expressing Neuroendocrine Neoplasms (NENs) and Other SST2-Expressing Solid Tumors

NCT07129252•Crinetics Pharmaceuticals Inc.

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (21)

Crinetics Study Site

Duarte, California, United States

Crinetics Study Site

Newport Beach, California, United States

Crinetics Study Site

Orange, California, United States

Crinetics Study Site

San Francisco, California, United States

Crinetics Study Site

Denver, Colorado, United States

Crinetics Study Site

New Haven, Connecticut, United States

Crinetics Study Site

Atlanta, Georgia, United States

Crinetics Study Site

Lexington, Kentucky, United States

Crinetics Study Site

Metairie, Louisiana, United States

Crinetics Study Site

Grand Rapids, Michigan, United States

Key Dates

Start Date

November 26, 2025

Primary Completion Date

August 1, 2027

Completion Date

August 1, 2029

Last Updated

March 10, 2026

Enrollment

150

ESTIMATED participants

Conditions

SST2-positive Neuroendocrine NeoplasmsNeuroendocrine TumorsNeuroendocrine Neoplasm

Interventions

CRN09682

DRUG

Contacts

Crinetics Clinical Trials

CONTACT

833-276-4636 clinicaltrials@crinetics.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 10, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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