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Active, not recruiting Phase 1/2

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

NCT07129252 · tracked via the Priya Life Science USA tracker
Phase
Phase 1/2
Started
2025-11-26
Last updated
2026-10-13

Condition(s) studied

SST2-positive Neuroendocrine NeoplasmsNeuroendocrine TumorsNeuroendocrine Neoplasm

Investigational drug(s) / intervention(s)

CRN09682

CRN09682: Study drug CRN09682 intravenously

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • (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.

Trial sites (27)

FacilityCityRegionStatus
Crinetics Study Site Phoenix Arizona
Crinetics Study Site Duarte California
Crinetics Study Site Newport Beach California
Crinetics Study Site Orange California
Crinetics Study Site San Francisco California
Crinetics Study Site Aurora Colorado
Crinetics Study Site Denver Colorado
Crinetics Study Site New Haven Connecticut
Crinetics Study Site Atlanta Georgia
Crinetics Study Site Lexington Kentucky
Crinetics Study Site Metairie Louisiana
Crinetics Study Site Detroit Michigan
Crinetics Study Site Grand Rapids Michigan
Crinetics Study Site Rochester Minnesota
Crinetics Study Site New York New York
Crinetics Study Site Philadelphia Pennsylvania
Crinetics Study Site Philadelphia Pennsylvania
Crinetics Study Site Austin Texas
Crinetics Study Site Houston Texas
Crinetics Study Site Irving Texas
Crinetics Study Site Salt Lake City Utah
Crinetics Study Site Charlottesville Virginia
Crinetics Study Site Fairfax Virginia
Crinetics Study Site Barcelona Spain
Crinetics Study Site Barcelona Spain
Crinetics Study Site Madrid Spain
Crinetics Study Site Madrid Spain
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07129252 on ClinicalTrials.gov ↗ ← All trials in the USA