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 (BRAVESST2)

NCT07129252 Phase 1/Phase 2 RECRUITING

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.

Details

Lead sponsor	Crinetics Pharmaceuticals Inc.
Phase	Phase 1/Phase 2
Status	RECRUITING
Enrolment	150
Start date	2025-11-26
Completion	2029-08

Conditions

• SST2-positive Neuroendocrine Neoplasms
• Neuroendocrine Tumors
• Neuroendocrine Neoplasm

Interventions

• CRN09682

Primary outcomes

• (Dose Escalation) Incidence and severity of DLTs. — From first dose through Day 21.
• (Dose Escalation) Incidence and severity of AEs and SAEs at each dose level and incidence of AEs leading to discontinuation from study drug. — From first dose of study drug to 30 days after the last dose.
• (Dose Expansion) Nature, incidence, and severity of AEs and SAEs at the Expansion Dose. — From first dose of study drug to 30 days after the last dose.
• (Dose Expansion) Interruptions at the Expansion Dose. — At Day 1 of each cycle through study completion, approximately 2 years.

Countries

United States, Spain