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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
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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.
About the study
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.
What is being tested
- CRN09682 (drug)
Sponsor: Crinetics Pharmaceuticals Inc. · Participants: 150 · Started: Nov 26, 2025
Contact the study team
- Contact if you are a potential participant or caregiver · Phone: 833-827-9741
- Contact if you are an HCP/clinical site staff/other · Phone: 833-827-9741
Official record on ClinicalTrials.gov — NCT07129252
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.