SST2-positive Neuroendocrine NeoplasmsPhase 1/2BRAVESST2NCT07129252
A Study to Investigate Safety and Effectiveness of CRN09682 in Participants With SST2-Expressing NENs and Other Solid Tumors
A Phase 1/2 study testing CRN09682 in people with SST2-positive Neuroendocrine Neoplasms and Neuroendocrine Tumors, run by Crinetics Pharmaceuticals Inc. at 27 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SST2-positive Neuroendocrine Neoplasms, Neuroendocrine Tumors, Neuroendocrine Neoplasm
- What is being tested?
- CRN09682
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 27 sitesin 2 countries
- Study dates
- 26 Nov 2025to Aug 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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 locations and contacts
27 sites in 2 countries.
27 sites in 2 countries
United States23 sites
Crinetics Study Site
Atlanta, Georgia, 30322
Crinetics Study Site
Aurora, Colorado, 80045
Crinetics Study Site
Austin, Texas, 78758
Crinetics Study Site
Charlottesville, Virginia, 22908
Crinetics Study Site
Denver, Colorado, 80218
Crinetics Study Site
Detroit, Michigan, 48201
Crinetics Study Site
Duarte, California, 91010
Crinetics Study Site
Fairfax, Virginia, 22031
Crinetics Study Site
Grand Rapids, Michigan, 49503
Crinetics Study Site
Houston, Texas, 70030
Crinetics Study Site
Irving, Texas, 75039
Crinetics Study Site
Lexington, Kentucky, 40536
Crinetics Study Site
Metairie, Louisiana, 70006
Crinetics Study Site
New Haven, Connecticut, 48201
Crinetics Study Site
New York, New York, 10016
Crinetics Study Site
Newport Beach, California, 92663
Crinetics Study Site
Orange, California, 92868
Crinetics Study Site
Philadelphia, Pennsylvania, 19104
Crinetics Study Site
Philadelphia, Pennsylvania, 19111
Crinetics Study Site
Phoenix, Arizona, 85054
Crinetics Study Site
Rochester, Minnesota, 53905
Crinetics Study Site
Salt Lake City, Utah, 84112
Crinetics Study Site
San Francisco, California, 60637
Spain4 sites
Crinetics Study Site
Barcelona, 08023
Crinetics Study Site
Barcelona, 08035
Crinetics Study Site
Madrid, 28040
Crinetics Study Site
Madrid, 28041
About this study
Official title: 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
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.
- Being tested
- CRN09682
- Keywords
- CRN09682, Crinetics, Neuroendocrine Neoplasm, NEN, Neuroendocrine Tumor, NET, MMAE, SST2, Somatostatin, Metastatic, Solid Tumor, Dose Escalation, Dose Expansion, Phase 1, SSTR+, Phase 2, Phase 1/2, Neuroendocrine Carcinoma, NEC
- Medical subject headings
- Neuroendocrine Tumors, Neoplasm Metastasis, Carcinoma, Neuroendocrine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRN09682Drug
Study drug CRN09682 intravenously
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation | Experimental | Multiple Dose Levels administered Q3W Receives: Drug: CRN09682 |
| Dose Expansion: Cohort 1 | Experimental | Pancreatic Neuroendocrine Tumor (NET) Receives: Drug: CRN09682 |
| Dose Expansion: Cohort 2 | Experimental | Non-Pancreatic NET Receives: Drug: CRN09682 |
| Dose Expansion: Cohort 3 | Experimental | Neuroendocrine Carcinoma (NEC) Receives: Drug: CRN09682 |
| Dose Expansion: Cohort 4 | Experimental | Other Solid Tumors Receives: Drug: CRN09682 |
What is being measured
The primary outcome is the main question the study is designed to answer.
(Dose Escalation) Incidence and severity of DLTs.
Measured: 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.
Measured: 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.
Measured: From first dose of study drug to 30 days after the last dose.
(Dose Expansion) Interruptions at the Expansion Dose.
Measured: At Day 1 of each cycle through study completion, approximately 2 years.
Secondary outcomes (10)
(Dose Escalation) Maximum Plasma Concentration (Cmax) of CRN09682 and MMAE .
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Throughout the study until disease progression or death whichever occurs first, approximately 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start26 Nov 2025
- Primary completionAug 2027 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SST2-positive Neuroendocrine NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- This is a Phase 1/2, 2-part, multicenter, open-label, nonrandomized, multiple-dose, first-in-human study (with dose escalation and expansion phase) of CRN09682 in participants with NENs and other solid tumors.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Crinetics Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07129252
- Sponsor's protocol ID
- CRN09682-191
- Acronym
- BRAVESST2
- Status last verified
- Oct 2026
- First submitted
- 1 Jul 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07129252
- Acronym / sponsor ID
- BRAVESST2 / CRN09682-191
- Keywords
- CRN09682, Crinetics, Neuroendocrine Neoplasm, NEN, Neuroendocrine Tumor, NET, MMAE, SST2
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Crinetics Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Nov 2025 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 19 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- This is a Phase 1/2, 2-part, multicenter, open-label, nonrandomized, multiple-dose, first-in-human study (with dose escalation and expansion phase) of CRN09682 in participants with NENs and other solid tumors.
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation | Experimental | Drug: CRN09682Multiple Dose Levels administered Q3W |
| Dose Expansion: Cohort 1 | Experimental | Drug: CRN09682Pancreatic Neuroendocrine Tumor (NET) |
| Dose Expansion: Cohort 2 | Experimental | Drug: CRN09682Non-Pancreatic NET |
| Dose Expansion: Cohort 3 | Experimental | Drug: CRN09682Neuroendocrine Carcinoma (NEC) |
| Dose Expansion: Cohort 4 | Experimental | Drug: CRN09682Other Solid Tumors |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CRN09682Study drug CRN09682 intravenously | Drug | Dose Escalation, Dose Expansion: Cohort 1, Dose Expansion: Cohort 2, Dose Expansion: Cohort 3, Dose Expansion: Cohort 4 |
Primary outcome
(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.
10 secondary outcomes
(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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
27 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CRN09682 in people with SST2-positive Neuroendocrine Neoplasms and Neuroendocrine Tumors, run by Crinetics Pharmaceuticals Inc. at 27 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
(Dose Escalation) Incidence and severity of DLTs. (time frame: From first dose through Day 21.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.