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
Crinetics Pharmaceuticals Inc.
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
- Age range
- 18+ years
- Sex
- All
- 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…
Interventions
- DrugCRN09682
Study drug CRN09682 intravenously
Locations (21)
- Crinetics Study SiteDuarte, California
- Crinetics Study SiteNewport Beach, California
- Crinetics Study SiteOrange, California
- Crinetics Study SiteSan Francisco, California
- Crinetics Study SiteDenver, Colorado
- Crinetics Study SiteNew Haven, Connecticut