CRN09682 for SST2-expressing neuroendocrine and other solid tumors
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
PHASE1; PHASE2 · Crinetics Pharmaceuticals Inc. · NCT07129252
See if CRN09682 is safe and helps people with SST2-expressing neuroendocrine tumors and some other solid tumors.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Crinetics Pharmaceuticals Inc. (industry) |
| Locations | 24 sites (Phoenix, Arizona and 23 other locations) |
| Trial ID | NCT07129252 on ClinicalTrials.gov |
What this trial studies
This is a Phase 1/2, multicenter, open-label, first-in-human study testing CRN09682 in participants with SST2-expressing neuroendocrine neoplasms and certain other solid tumors. A dose-escalation phase will determine the maximum tolerated dose and dose-limiting toxicities, followed by an expansion phase at the selected dose to further characterize safety, tolerability, pharmacokinetics, and preliminary antitumor activity. Eligible participants must have histologically confirmed metastatic or unresectable NETs or other solid tumors with SST2 expression, measurable disease by RECIST 1.1, and an ECOG performance status of 0–2. Key exclusions include recent progression on peptide receptor radionuclide therapy, unstable brain metastases, or recent anticancer therapies or local tumor procedures.
Who should consider this trial
Good fit: Ideal candidates have metastatic or locally advanced inoperable neuroendocrine tumors or other solid tumors that express SST2, have measurable disease and radiologic progression, and an ECOG status of 0–2.
Not a fit: Patients without SST2 expression, those who progressed during or within six months after PRRT, those with unstable brain metastases, or those who recently received other anticancer treatments are unlikely to benefit or may be ineligible.
Why it matters
Potential benefit: If successful, CRN09682 could offer a new targeted treatment option for patients with SST2-expressing neuroendocrine tumors that may control tumor growth with an acceptable safety profile.
How similar studies have performed: SST2-targeted approaches such as somatostatin analogs and peptide receptor radionuclide therapy have demonstrated benefit in NETs, but CRN09682 is a first-in-human agent and its efficacy in humans is untested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Phoenix, Arizona and 23 other locations
- Crinetics Study Site — Phoenix, Arizona, United States (RECRUITING)
- Crinetics Study Site — Duarte, California, United States (RECRUITING)
- Crinetics Study Site — Newport Beach, California, United States (RECRUITING)
- Crinetics Study Site — Orange, California, United States (RECRUITING)
- Crinetics Study Site — San Francisco, California, United States (RECRUITING)
- Crinetics Study Site — Denver, Colorado, United States (RECRUITING)
- Crinetics Study Site — New Haven, Connecticut, United States (RECRUITING)
- Crinetics Study Site — Atlanta, Georgia, United States (RECRUITING)
- Crinetics Study Site — Lexington, Kentucky, United States (RECRUITING)
- Crinetics Study Site — Metairie, Louisiana, United States (RECRUITING)
- Crinetics Study Site — Detroit, Michigan, United States (RECRUITING)
- Crinetics Study Site — Grand Rapids, Michigan, United States (RECRUITING)
- Crinetics Study Site — Rochester, Minnesota, United States (RECRUITING)
- Crinetics Study Site — Philadelphia, Pennsylvania, United States (RECRUITING)
- Crinetics Study Site — Austin, Texas, United States (RECRUITING)
- Crinetics Study Site — Houston, Texas, United States (RECRUITING)
- Crinetics Study Site — Irving, Texas, United States (RECRUITING)
- Crinetics Study Site — Salt Lake City, Utah, United States (RECRUITING)
- Crinetics Study Site — Charlottesville, Virginia, United States (RECRUITING)
- Crinetics Study Site — Fairfax, Virginia, United States (RECRUITING)
- Crinetics Study Site — Barcelona, Spain (RECRUITING)
- Crinetics Study Site — Barcelona, Spain (RECRUITING)
- Crinetics Study Site — Madrid, Spain (RECRUITING)
- Crinetics Study Site — Madrid, Spain (RECRUITING)
Study contacts
- Study coordinator: Crinetics Clinical Trials
- Email: clinicaltrials@crinetics.com
- Phone: 833-827-9741
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: SST2-positive Neuroendocrine Neoplasms, Neuroendocrine Tumors, Neuroendocrine Neoplasm, CRN09682, Crinetics, NEN, Neuroendocrine Tumor, NET