150 Participants Needed

CRN09682 for Neuroendocrine Tumors

(BRAVESST2 Trial)

Recruiting at 5 trial locations
CC
Overseen ByCrinetics Clinical Trials
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Crinetics Pharmaceuticals Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines a new treatment, CRN09682, for individuals with certain tumors, such as neuroendocrine tumors (NETs) and other solid growths. The trial aims to assess the safety and effectiveness of this treatment and determine the optimal dose. It involves different groups, focusing on tumors related to the pancreas, other neuroendocrine areas, and more. Suitable candidates have tumors that cannot be surgically removed and have shown growth on scans. As a Phase 1 trial, this research seeks to understand how the treatment works in people, offering participants the opportunity to be among the first to receive it.

Is there any evidence suggesting that CRN09682 is likely to be safe for humans?

Research has shown that CRN09682 is in the early stages of testing, focusing on its safety and tolerability. Currently, detailed information on side effects from these studies is unavailable. The trial aims to determine the treatment's safety by assessing any serious side effects and how well patients manage different doses. As the trial is just beginning, researchers are closely monitoring safety to ensure it is generally well-tolerated. This treatment is not yet approved for any conditions, so safety information is still being collected.12345

Why do researchers think this study treatment might be promising for neuroendocrine tumors?

Researchers are excited about CRN09682 because it offers a new approach to treating neuroendocrine tumors (NETs), which include pancreatic and non-pancreatic NETs, as well as neuroendocrine carcinoma. Unlike traditional treatments such as somatostatin analogs or targeted therapies like everolimus and sunitinib, CRN09682 is being tested across multiple dosing strategies, including dose escalation and expansion cohorts. This method allows researchers to fine-tune the dosage for optimal effectiveness and safety, potentially offering a more personalized treatment option. Additionally, the unique dosing schedule of administering multiple dose levels every three weeks (Q3W) could lead to improved outcomes and patient experiences.

What evidence suggests that CRN09682 might be an effective treatment for neuroendocrine tumors?

Research has shown that CRN09682 is under study as a potential treatment for neuroendocrine tumors in this trial. This drug targets a specific part of the tumor known as somatostatin receptor 2. Early results are promising, particularly for patients with high levels of the protein DLL3, with about 40% experiencing tumor shrinkage. Overall, about 67% of patients in studies have shown some positive response to similar treatments. While further research is necessary, these early findings suggest that CRN09682 could be a promising option for individuals with neuroendocrine tumors.16789

Are You a Good Fit for This Trial?

This trial is for people with certain types of tumors that show up on special scans (SST2-expressing NENs and other solid tumors). Participants should be able to perform daily activities with ease or have only slight limitations, and must have a confirmed diagnosis of advanced or metastatic neuroendocrine carcinoma, pancreatic cancer, carcinoid tumor, or similar conditions that are getting worse.

Inclusion Criteria

Have one or more measurable disease location per RECIST version 1.1
My cancer is advanced, cannot be removed by surgery, and is getting worse.
My tumor shows SSR activity on imaging tests.
See 1 more

Exclusion Criteria

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
Have hypersensitivity or history of anaphylactic reaction to octreotide, other SSAs, and/or MMAE
My cancer got worse during or within 6 months after PRRT treatment.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive multiple dose levels of CRN09682 administered every 3 weeks to determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs)

Varies

Dose Expansion

Additional participants are enrolled at the expansion dose to further assess safety, tolerability, pharmacokinetics (PK), and antitumor activity

Varies

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • CRN09682
Trial Overview The study tests CRN09682's safety and effectiveness. It has two parts: first, finding the highest dose patients can take without serious side effects (Dose Escalation Phase), then giving more people this dose to see how well it works and what side effects occur (Expansion Phase).
How Is the Trial Designed?
5Treatment groups
Experimental Treatment
Group I: Dose Expansion: Cohort 4Experimental Treatment1 Intervention
Group II: Dose Expansion: Cohort 3Experimental Treatment1 Intervention
Group III: Dose Expansion: Cohort 2Experimental Treatment1 Intervention
Group IV: Dose Expansion: Cohort 1Experimental Treatment1 Intervention
Group V: Dose EscalationExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Crinetics Pharmaceuticals Inc.

Lead Sponsor

Trials
13
Recruited
760+

Citations

Crinetics Announces First Patient Dosed in Phase 1/2 Trial ...Crinetics Announces First Patient Dosed in Phase 1/2 Trial Evaluating CRN09682 for the Treatment of Neuroendocrine Tumors and Other Somatostatin ...
NCT07129252 | A Study to Investigate Safety and ...This Phase 1/2, multicenter, open-label, FIH study aims to evaluate the safety, tolerability, PK, and preliminary antitumor activity of CRN09682 in ...
Clinical Trial DetailsMetastatic or locally advanced SST2-positive neuroendocrine neoplasms in adults - A Study to Investigate Safety and Effectiveness of CRN09682 in ...
News DetailsCRN09682 is an investigational, potentially first-in-class, non-radioactive, nonpeptide drug conjugate (NDC) linking a somatostatin receptor 2 ...
Clinical Trials Aim to Advance the Future of ...The results show encouraging signs, especially in patients whose tumors have high levels of DLL3, where 40% saw their tumors shrink. Overall, 67 ...
Crinetics to Highlight Neuroendocrine Tumor Research ...CRN09682 is an investigational, potentially first-in-class, non-radioactive, nonpeptide drug conjugate (NDC) linking a somatostatin receptor 2 ( ...
First Patient Dosed in Crinetics' Neuroendocrine Tumor TrialCRN09682 will need to demonstrate a tolerable DLT window, manageable peripheral neuropathy and hematologic safety, and clear signs of target- ...
Crinetics Announces First Patient Dosed in Phase 1/2 Trial ...CRN09682 is an investigational, first-in-class, non-radioactive, nonpeptide drug conjugate (NDC) linking a somatostatin receptor 2 (SST2) ...
A Study to Investigate Safety and Effectiveness of CRN09682 ...This Phase 1/2, multicenter, open-label, FIH study aims to evaluate the safety, tolerability, PK, and preliminary antitumor activity of ...
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