A Study To Investigate Safety And Effectiveness Of CRN09682 In Participants With SST2-Expressing NENs And Other Solid Tumors

Overview

About this 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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 12/22/2025. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Mohamad Bassam Sonbol

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Rochester, Minn.

Mayo Clinic principal investigator

Thorvardur Halfdanarson

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available
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CLS-20597509

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