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

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
Crinetics Study Site
RECRUITING
Newport Beach
Colorado
Crinetics Study Site
RECRUITING
Denver
Michigan
Crinetics Study Site
RECRUITING
Grand Rapids
Texas
Crinetics Study Site
RECRUITING
Austin
Crinetics Study Site
RECRUITING
Irving
Virginia
Crinetics Study Site
RECRUITING
Fairfax
Contact Information
Primary
Crinetics Clinical Trials
clinicaltrials@crinetics.com
833-276-4636
Time Frame
Start Date: 2025-11-26
Estimated Completion Date: 2029-08
Participants
Target number of participants: 150
Treatments
Experimental: Dose Escalation
Multiple Dose Levels administered Q3W
Experimental: Dose Expansion: Cohort 1
Pancreatic Neuroendocrine Tumor (NET)
Experimental: Dose Expansion: Cohort 2
Non-Pancreatic NET
Experimental: Dose Expansion: Cohort 3
Neuroendocrine Carcinoma (NEC)
Experimental: Dose Expansion: Cohort 4
Other Solid Tumors
Related Therapeutic Areas
Sponsors
Leads: Crinetics Pharmaceuticals Inc.

This content was sourced from clinicaltrials.gov

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