Recruiting
Phase 1
Phase 2

CRN09682

Sponsor:

Crinetics Pharmaceuticals Inc.

Code:

NCT07129252

Conditions

SST2-positive Neuroendocrine Neoplasms

Neuroendocrine Tumors

Neuroendocrine Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CRN09682

Study Details

Brief 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.

Conditions

SST2-positive Neuroendocrine Neoplasms

Neuroendocrine Tumors

Neuroendocrine Neoplasm

Study ID

NCT07129252

Start date

Nov 26, 2025

Status verified date

Mar, 2026

Completion date

Aug, 2029

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

150 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose Escalation

Multiple Dose Levels administered Q3W

experimental: Dose Expansion: Cohort 1

Pancreatic Neuroendocrine Tumor (NET)

experimental: Dose Expansion: Cohort 2

Non-Pancreatic NET

experimental: Dose Expansion: Cohort 3

Neuroendocrine Carcinoma (NEC)

experimental: Dose Expansion: Cohort 4

Other Solid Tumors

Interventions

CRN09682

Study drug CRN09682 intravenously

Primary outcome measure

  • (Dose Escalation) Incidence and severity of DLTs. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: From first dose of study drug to 30 days after the last dose. ]
  • (Dose Expansion) Interruptions at the Expansion Dose. [ Time Frame: At Day 1 of each cycle through study completion, approximately 2 years. ]

Central Contacts and Locations

Central contacts

Contact if you are a potential participant or caregiver

833-827-9741studyinfo@crinetics.com

Contact if you are an HCP/clinical site staff/other

833-827-9741clinicalsites@crinetics.com

Locations

Crinetics Study Site

Recruiting

Phoenix, Arizona, United States, 85054

Crinetics Study Site

Recruiting

Duarte, California, United States, 91010

Crinetics Study Site

Recruiting

Newport Beach, California, United States, 92663

Crinetics Study Site

Recruiting

Orange, California, United States, 92868

Crinetics Study Site

Recruiting

San Francisco, California, United States, 60637

Crinetics Study Site

Recruiting

Aurora, Colorado, United States, 80045

Crinetics Study Site

Recruiting

Denver, Colorado, United States, 80218

Crinetics Study Site

Recruiting

New Haven, Connecticut, United States, 48201

Crinetics Study Site

Recruiting

Atlanta, Georgia, United States, 30322

Crinetics Study Site

Recruiting

Lexington, Kentucky, United States, 40536

Crinetics Study Site

Recruiting

Metairie, Louisiana, United States, 70006

Crinetics Study Site

Recruiting

Detroit, Michigan, United States, 48201

Crinetics Study Site

Recruiting

Grand Rapids, Michigan, United States, 49503

Crinetics Study Site

Recruiting

Rochester, Minnesota, United States, 53905

Crinetics Study Site

Recruiting

New York, New York, United States, 10016

Crinetics Study Site

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Crinetics Study Site

Recruiting

Philadelphia, Pennsylvania, United States, 19111

Crinetics Study Site

Recruiting

Austin, Texas, United States, 78758

Crinetics Study Site

Recruiting

Houston, Texas, United States, 70030

Crinetics Study Site

Recruiting

Irving, Texas, United States, 75039

Crinetics Study Site

Recruiting

Salt Lake City, Utah, United States, 84112

Crinetics Study Site

Recruiting

Charlottesville, Virginia, United States, 22908

Crinetics Study Site

Recruiting

Fairfax, Virginia, United States, 22031

More Information

Sponsor

Crinetics Pharmaceuticals Inc.

Last update posted

Jul 31, 2026

Last verified

Mar, 2026

Keywords

  • CRN09682
  • Crinetics
  • Neuroendocrine Neoplasm
  • NEN
  • Neuroendocrine Tumor
  • NET
  • MMAE
  • SST2
  • Somatostatin
  • Metastatic
  • Solid Tumor
  • Dose Escalation
  • Dose Expansion
  • Phase 1
  • SSTR+
  • Phase 2
  • Phase 1/2
  • Neuroendocrine Carcinoma
  • NEC

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Crinetics Pharmaceuticals Inc. on 2026-07-31.