A Phase 1/2 interventional study of CRN09682 in SST2-positive Neuroendocrine Neoplasms, Neuroendocrine Tumors and Neuroendocrine Neoplasm, sponsored by Crinetics Pharmaceuticals Inc.. Active, not recruiting at 27 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Crinetics Pharmaceuticals Inc. (part of Vertex Pharmaceuticals Incorporated) · Phase 1/2, Interventional, and Treatment
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.
542 studies on the registry are indexed under Neuroendocrine Tumors; 135 are open to participants now.
This study's planned enrollment of 150 is above the median of 41 across 387 interventional studies indexed under Neuroendocrine Tumors.
Browse Neuroendocrine Tumors studies →Crinetics Pharmaceuticals Inc. is the lead sponsor of 19 studies on the registry; 3 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 6 (50%) have results posted.
First submitted before Crinetics Pharmaceuticals Inc. became part of Vertex Pharmaceuticals Incorporated.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Multiple Dose Levels administered Q3W
Drug: CRN09682
Pancreatic Neuroendocrine Tumor (NET)
Drug: CRN09682
Non-Pancreatic NET
Drug: CRN09682
Neuroendocrine Carcinoma (NEC)
Drug: CRN09682
Other Solid Tumors
Drug: CRN09682
Study drug CRN09682 intravenously
(Dose Escalation) Incidence and severity of DLTs.
Time frame: 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.
Time frame: 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.
Time frame: From first dose of study drug to 30 days after the last dose.
(Dose Expansion) Interruptions at the Expansion Dose.
Time frame: At Day 1 of each cycle through study completion, approximately 2 years.
(Dose Escalation) Maximum Plasma Concentration (Cmax) of CRN09682 and MMAE .
Time frame: Day 1 of each cycle (each cycle is 21 days) for the duration of the study, from baseline to safety follow-up visit, up to 2 years.
(Dose Escalation) Time to Maximum Concentration (Tmax) of CRN09682 and MMAE.
Time frame: Day 1 of each cycle (each cycle is 21 days) for the duration of the study, from baseline to safety follow-up visit, up to 2 years.
(Dose Escalation) Measure of CRN09682 and MMAE exposure in the body from initial dose to the last measurable concentration (AUC0-last).
Time frame: Day 1 of each cycle (each cycle is 21 days) for the duration of the study, from baseline to safety follow-up visit, up to 2 years.
(Dose Escalation) Measure of total CRN09682 exposure in the body across time (AUC0-inf).
Time frame: Day 1 of each cycle (each cycle is 21 days) for the duration of the study, from baseline to safety follow-up visit, up to 2 years.
(Dose Escalation) The amount of time required for CRN09682 to be reduced to half of its initial concentration in the blood (t1/2).
Time frame: Day 1 of each cycle (each cycle is 21 days) for the duration of the study, from baseline to safety follow-up visit, up to 2 years.
(Dose Escalation & Expansion) Objective response rate (ORR): The percentage of patients with best overall response of complete response or partial response according to RECIST 1.1
Time frame: Throughout the study until disease progression or the last evaluable assessment in the absence of progression whichever occurs first, approximately 2 years.
(Dose Escalation & Expansion) Disease control rate (DCR): The percentage of patients with best overall response of complete response, partial response, or stable disease according to RECIST 1.1
Time frame: Throughout the study until disease progression or the last evaluable assessment in the absence of progression whichever occurs first , approximately 2 years.
(Dose Escalation & Expansion) Duration of response (DOR): The time from the date of first objective response until date of disease progression or death in the absence of disease progression, according to RECIST 1.1.
Time frame: From the first documented objective response to disease progression or death whichever occurs first, approximately 2 years.
(Dose Expansion) Changes in somatostatin receptor imaging: Evaluate changes in SSR tracer uptake over time, based on whether uptake is greater than or less than liver uptake.
Time frame: Throughout the study at predefined intervals, approximately 2 years.
(Dose Expansion) Radiographic PFS: The time from the start of study drug until RECIST 1.1 defined disease progression or death in the absence of disease progression.
Time frame: Throughout the study until disease progression or death whichever occurs first, approximately 2 years.
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2025 (actual). Primary completion is estimated for Aug 2027, 21 months after the start.
Of 29 phase 1/2 interventional studies under Neuroendocrine Tumors, half reached primary completion within 84 months of starting (the median), counting those still running; a quarter within 52 and three quarters within 122. This study's planned 21 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Crinetics Pharmaceuticals Inc. →