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

NCT07129252 | Recruiting Phase 1 FDA Drug

• 1 other identifier: CRN09682-191
• Study Type: interventional
• Target: 150
• Locations: 2 countries
• Sites: 21

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

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

Outcome Measures

Primary Outcomes (4)

• (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.

Secondary Outcomes (10)

• (Dose Escalation) Maximum Plasma Concentration (Cmax) of CRN09682 and MMAE .

  Day 1 of each cycle (each cycle is 21 days) for the duration of the study, from baseline to safety follow-up visit, up to 2 years.

• (Dose Escalation) Time to Maximum Concentration (Tmax) of CRN09682 and MMAE.

  Day 1 of each cycle (each cycle is 21 days) for the duration of the study, from baseline to safety follow-up visit, up to 2 years.

• (Dose Escalation) Measure of CRN09682 and MMAE exposure in the body from initial dose to the last measurable concentration (AUC0-last).

  Day 1 of each cycle (each cycle is 21 days) for the duration of the study, from baseline to safety follow-up visit, up to 2 years.

• (Dose Escalation) Measure of total CRN09682 exposure in the body across time (AUC0-inf).

  Day 1 of each cycle (each cycle is 21 days) for the duration of the study, from baseline to safety follow-up visit, up to 2 years.

• (Dose Escalation) The amount of time required for CRN09682 to be reduced to half of its initial concentration in the blood (t1/2).

  Day 1 of each cycle (each cycle is 21 days) for the duration of the study, from baseline to safety follow-up visit, up to 2 years.

Study Arms (5)

Dose Escalation

EXPERIMENTAL

Multiple Dose Levels administered Q3W

Drug: CRN09682

Dose Expansion: Cohort 1

EXPERIMENTAL

Pancreatic Neuroendocrine Tumor (NET)

Drug: CRN09682

Dose Expansion: Cohort 2

EXPERIMENTAL

Non-Pancreatic NET

Drug: CRN09682

Dose Expansion: Cohort 3

EXPERIMENTAL

Neuroendocrine Carcinoma (NEC)

Drug: CRN09682

Dose Expansion: Cohort 4

EXPERIMENTAL

Other Solid Tumors

Drug: CRN09682

Interventions

CRN09682 DRUG

Study drug CRN09682 intravenously

Dose Escalation; Dose Expansion: Cohort 1; Dose Expansion: Cohort 2; Dose Expansion: Cohort 3; Dose Expansion: Cohort 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Crinetics Pharmaceuticals Inc.: lead

Study Sites (21)

Crinetics Study Site

Duarte, California, 91010, United States

RECRUITING

Crinetics Study Site

Newport Beach, California, 92663, United States

RECRUITING

Crinetics Study Site

Orange, California, 92868, United States

RECRUITING

Crinetics Study Site

San Francisco, California, 60637, United States

RECRUITING

Crinetics Study Site

Denver, Colorado, 80218, United States

RECRUITING

Crinetics Study Site

New Haven, Connecticut, 48201, United States

RECRUITING

Crinetics Study Site

Atlanta, Georgia, 30322, United States

RECRUITING

Crinetics Study Site

Lexington, Kentucky, 40536, United States

RECRUITING

Crinetics Study Site

Metairie, Louisiana, 70006, United States

RECRUITING

Crinetics Study Site

Grand Rapids, Michigan, 49503, United States

RECRUITING

Crinetics Study Site

Philadelphia, Pennsylvania, 19111, United States

RECRUITING

Crinetics Study Site

Austin, Texas, 78758, United States

RECRUITING

Crinetics Study Site

Houston, Texas, 70030, United States

RECRUITING

Crinetics Study Site

Irving, Texas, 75039, United States

RECRUITING

Crinetics Study Site

Salt Lake City, Utah, 84112, United States

RECRUITING

Crinetics Study Site

Charlottesville, Virginia, 22908, United States

RECRUITING

Crinetics Study Site

Fairfax, Virginia, 22031, United States

RECRUITING

Crinetics Study Site

Barcelona, 08023, Spain

RECRUITING

Crinetics Study Site

Barcelona, 08035, Spain

RECRUITING

Crinetics Study Site

Madrid, 28040, Spain

RECRUITING

Crinetics Study Site

Madrid, 28041, Spain

RECRUITING

MeSH Terms

Conditions

Neuroendocrine Tumors; Neoplasm Metastasis; Carcinoma, Neuroendocrine

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial

Central Study Contacts

Crinetics Clinical Trials

CONTACT

833-276-4636; clinicaltrials@crinetics.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 1, 2025
• First Posted: August 19, 2025
• Study Start: November 26, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2029
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (4); US (17)