About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • CRN09682

Treatment groups

150 Participants
are divided into 5 treatment groups

Locations

26
Spain
Crinetics Study Site08023, Barcelona Spain
Crinetics Study Site08035, Barcelona Spain
Crinetics Study Site28040, Madrid Spain
Crinetics Study Site28041, Madrid Spain

Sponsors and collaborators

Crinetics Pharmaceuticals Inc.

Lead sponsor