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

NCT ID: NCT07129252

Last Updated: 2026-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-26

Study Completion Date

2029-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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SST2-positive Neuroendocrine Neoplasms Neuroendocrine Tumors Neuroendocrine Neoplasm

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dose Escalation

Multiple Dose Levels administered Q3W

Group Type EXPERIMENTAL

CRN09682

Intervention Type DRUG

Study drug CRN09682 intravenously

Dose Expansion: Cohort 1

Pancreatic Neuroendocrine Tumor (NET)

Group Type EXPERIMENTAL

CRN09682

Intervention Type DRUG

Study drug CRN09682 intravenously

Dose Expansion: Cohort 2

Non-Pancreatic NET

Group Type EXPERIMENTAL

CRN09682

Intervention Type DRUG

Study drug CRN09682 intravenously

Dose Expansion: Cohort 3

Neuroendocrine Carcinoma (NEC)

Group Type EXPERIMENTAL

CRN09682

Intervention Type DRUG

Study drug CRN09682 intravenously

Dose Expansion: Cohort 4

Other Solid Tumors

Group Type EXPERIMENTAL

CRN09682

Intervention Type DRUG

Study drug CRN09682 intravenously

Interventions

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CRN09682

Study drug CRN09682 intravenously

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Crinetics Pharmaceuticals Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Crinetics Study Site

Denver, Colorado, United States

Site Status RECRUITING

Crinetics Study Site

Duarte, California, United States

Site Status RECRUITING

Crinetics Study Site

Newport Beach, California, United States

Site Status RECRUITING

Crinetics Study Site

New Haven, Connecticut, United States

Site Status RECRUITING

Crinetics Study Site

Atlanta, Georgia, United States

Site Status RECRUITING

Crinetics Study Site

Lexington, Kentucky, United States

Site Status RECRUITING

Crinetics Study Site

Metairie, Louisiana, United States

Site Status RECRUITING

Crinetics Study Site

Grand Rapids, Michigan, United States

Site Status RECRUITING

Crinetics Study Site

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Crinetics Study Site

Austin, Texas, United States

Site Status RECRUITING

Crinetics Study Site

Houston, Texas, United States

Site Status RECRUITING

Crinetics Study Site

Irving, Texas, United States

Site Status RECRUITING

Crinetics Study Site

Salt Lake City, Utah, United States

Site Status RECRUITING

Crinetics Study Site

Charlottesville, Virginia, United States

Site Status RECRUITING

Crinetics Study Site

Fairfax, Virginia, United States

Site Status RECRUITING

Crinetics Study Site

Barcelona, , Spain

Site Status RECRUITING

Crinetics Study Site

Madrid, , Spain

Site Status RECRUITING

Countries

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United States Spain

Central Contacts

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Crinetics Clinical Trials

Role: CONTACT

833-276-4636

Other Identifiers

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CRN09682-191

Identifier Type: -

Identifier Source: org_study_id

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