Phase 1/2 Trial Evaluating CRN09682 for the Treatment of Neuroendocrine Tumors and Other Somatostatin Receptor 2-Expressing Tumors

Crinetics Announces First Patient Dosed in Phase 1/2 Trial Evaluating CRN09682 for the Treatment of Neuroendocrine Tumours and Other Somatostatin Receptor 2-Expressing Tumours

Read the news – click here

Clinical Trial Document – click here

Limited to US (6 locations) (so far).

CRN09682, a first‑in‑class non‑peptide drug conjugate (NDC) developed by Crinetics Pharmaceuticals. The company recently announced that the first patient has been dosed in its Phase 1/2 clinical trial — a significant milestone for a therapy designed to deliver precision‑targeted cytotoxic activity without the use of radiation or standard chemotherapy.

What is CRN09682?

CRN09682 is engineered to target somatostatin receptor subtype 2 (SST2), which is highly expressed in most gastroenteropancreatic NETs and several other solid tumours. Unlike somatostatin analogues or paltusotine, CRN09682 is not intended to manage hormones or symptoms. Its purpose is tumour‑directed activity. Although some might argue that cytoreduction might decrease NET syndrome hormonal activity.

The drug uses a two‑component design:

A small‑molecule ligand that binds selectively to SST2
A potent cytotoxic payload (MMAE) that is released inside the tumour cell after internalisation

This approach is conceptually similar to antibody–drug conjugates (ADCs), but CRN09682 is much smaller, which may allow:

Better tumour penetration
Faster systemic clearance
More predictable pharmacokinetics

Importantly, while the payload is cytotoxic, the therapy itself is not “chemotherapy” in the traditional sense. It is a targeted drug conjugate, designed to deliver its payload selectively to tumour cells rather than exposing the whole body to cytotoxic agents.

About the Phase 1/2 Trial

The ongoing study is a first‑in‑human, dose‑escalation and dose‑expansion trial enrolling adults with advanced or metastatic SST2‑expressing tumours. (see link above)

Key features include:

Intravenous administration of CRN09682
Evaluation of safety, tolerability, and pharmacokinetics
Identification of the recommended dose for expansion
Early assessment of anti‑tumour activity

This is the foundational stage where researchers determine how the drug behaves in humans and what dose levels are appropriate for further study.

How does it compare to existing therapies?

CRN09682 is not a replacement for somatostatin analogues or paltusotine — it belongs to a different therapeutic class. Instead, it aims to join the growing family of tumour‑directed therapies, alongside existing NET therapies such as PRRT (approved and pipeline) (Lu‑177, Ac‑225, 212Pb agents) and other targeted small molecules (everolimus, sunitinib). This is the same company that is trialling an oral somatostatin analogue called Paltusotine for treatment of carcinoid syndrome. This trial here should not be confused with Paltusotine, it’s a totally different drug looking at anti-tumour effects but using the same target as most types of somatostatin analogue to access tumour cells.

What comes next?

As the trial progresses, we’ll learn more about:

Safety and tolerability
Optimal dosing
Early signs of tumour response
Suitability for broader NET populations

If results are encouraging, CRN09682 could advance into larger studies and potentially reshape the treatment landscape for SST2‑positive tumours.

About Crinetics Pharmaceuticals

Crinetics Pharmaceuticals is a global pharmaceutical company committed to transforming the treatment of endocrine diseases and endocrine-related tumours through science rooted in patient needs. Crinetics is focused on discovering, developing, and commercializing novel therapies, with a core expertise in targeting G-protein coupled receptors (GPCRs) with small molecules that have specifically tailored pharmacology and properties.

Crinetics’ lead product, PALSONIFY™ (paltusotine), is the first once-daily, oral treatment approved by the U.S. FDA for the treatment of adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option. Paltusotine is also in clinical development for carcinoid syndrome associated with neuroendocrine tumours. Crinetics’ deep pipeline of 10+ disclosed programs includes late-stage investigational candidate atumelnant, which is currently in late-stage development for congenital adrenal hyperplasia and ACTH-dependent Cushing’s syndrome. Additional discovery programs address a variety of endocrine conditions such as neuroendocrine tumours, Graves’ disease (including Graves’ hyperthyroidism and Graves’ orbitopathy, or thyroid eye disease), polycystic kidney disease, hyperparathyroidism, diabetes, obesity, and GPCR-targeted oncology indications.

Disclaimer

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Finally

Whenever I post about a trial or study, some people get excited without understanding that these new treatments and capabilities can very often take years to come to fruition and it’s also possible that clinical trials can be halted, or that national approval agencies will not approve the final product. Plus, not everyone will be eligible, so always check the exclusion and inclusion criteria in the relevant clinical trials document. Please bear that in mind when reading studies/clinical trials posted on RonnyAllan.NET