A Study to Investigate Safety and Effectiveness of CRN09682 in Participants With SST2-Expressing NENs and Other Solid Tumors

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCrinetics Pharmaceuticals Inc.

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

Sponsors and collaborators