NCT07129252 A Study to Investigate Safety and Effectiveness of CRN09682 in Participants With SST2-Expressing NENs and Other Solid Tumors
| NCT ID | NCT07129252 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Crinetics Pharmaceuticals Inc. |
| Condition | SST2-positive Neuroendocrine Neoplasms |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2025-11-26 |
| Primary Completion | 2027-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 150 participants in total. It began in 2025-11-26 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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 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. * Prior participation in any intervention clinical study within 30 days or 5 half-lives (whichever is longer) prior to the first dose of study drug. * Participants with carcinoid syndrome. * Secondary malignancy: participants who have any other malignancy known to be active or treated within 3 years of the start of screening, with the exception of treated cervical intraepithelial neoplasia, superficial (noninvasive) bladder cancer, and non-melanoma skin cancer. * Have prior treatment with MMAE. * Have hypersensitivity or history of anaphylactic reaction to octreotide, other SSAs, and/or MMAE.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07129252 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying SST2-positive Neuroendocrine Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07129252 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07129252 currently recruiting?
Yes, NCT07129252 is actively recruiting participants. Contact the research team at studyinfo@crinetics.com for enrollment information.
Where is the NCT07129252 trial being conducted?
This trial is being conducted at Phoenix, United States, Duarte, United States, Newport Beach, United States, Orange, United States and 11 additional locations.
Who is sponsoring the NCT07129252 clinical trial?
NCT07129252 is sponsored by Crinetics Pharmaceuticals Inc.. The trial plans to enroll 150 participants.