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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT07129252
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1/Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Crinetics Pharmaceuticals Inc.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	SST2-positive Neuroendocrine Neoplasms, Neuroendocrine Tumors, Neuroendocrine Neoplasm

Arms & Interventions

Arms

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

Interventions

Drug: - CRN09682

Study drug CRN09682 intravenously

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Crinetics Clinical Trials

[email protected]

833-827-9741

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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