CRN-09682 / Crinetics - LARVOL DELTA

BRAVESST2: A Study to Investigate Safety and Effectiveness of CRN09682 in Participants With SST2-Expressing NENs and Other Solid Tumors (clinicaltrials.gov) - P1/2 | N=150 | Recruiting | Sponsor: Crinetics Pharmaceuticals Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Endocrine Cancer • Neuroendocrine Carcinoma • Neuroendocrine Tumor • Oncology • Solid Tumor

Crinetics Announces First Patient Dosed in Phase 1/2 Trial Evaluating CRN09682 for the Treatment of Neuroendocrine Tumors and Other Somatostatin Receptor 2-Expressing Tumors (GlobeNewswire) - "The Phase 1/2 BRAVESST2 trial is a first-in-human, open-label, dose-escalation study with a dose expansion phase designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of CRN09682. The Phase 1 portion will enroll patients in escalating dose cohorts to determine the maximum tolerated dose and recommended dose for the expansion phase. Phase 2 will further evaluate and characterize CRN09682 in selected SST2-expressing tumor types."

Trial status • Neuroendocrine Neoplasm • Neuroendocrine Tumor

Key Upcoming Milestones (Crinetics Press Release) - "Crinetics expects the first patient to receive CRN09682 in the dose escalation phase of a Phase 1/2 study in the fourth quarter of 2025. This is the first candidate from the NDC platform and the study will include an expansion phase for the treatment of metastatic or locally advanced SST2-positive neuroendocrine tumors (NETs) and other SST2-expressing solid tumors."

Trial status • Neuroendocrine Neoplasm • Solid Tumor

Crinetics to Highlight Neuroendocrine Tumor Research Progress at the 2025 North American Neuroendocrine Tumor Society Annual Meeting (Crinetics Press Release) - "A preliminary analysis of Phase 2 data from the open-label trial of paltusotine in the treatment of patients with carcinoid syndrome due to NETs will be featured in a poster presentation, showing an overall investigator-assessed progression free survival rate of 74% following one year of treatment....Two additional poster presentations will feature study details from the randomized, Phase 3 trial of paltusotine in carcinoid syndrome due to NETs and the first-in-human study of NDC candidate CRN09682 in patients with somatostatin receptor 2-expressing tumors."

Clinical data • Carcinoid Syndrome • Neuroendocrine Tumor

First-in-Human Study of a Novel Nonpeptide Drug Conjugate (CRN09682) in Patients With Somatostatin Receptor 2-Expressing Tumors (NANETS 2025) - "Secondary endpoints include assessments of antitumor activity (eg, objective response rate, duration of response, and disease control rate, based on RECIST 1.1 criteria; progression-free survival, overall survival) and pharmacokinetic assessments. RESULTS N/A CONCLUSIONS Results of this study will be used to inform subsequent clinical trials to investigate the efficacy and safety of CRN09682 for patients with metastatic or locally advanced/unresectable neuroendocrine neoplasms or other SSTR2-expressing tumors."

Clinical • First-in-human • P1 data • Brain Cancer • Breast Cancer • Endocrine Cancer • Lung Cancer • Melanoma • Meningioma • Merkel Cell Carcinoma • Neuroendocrine Carcinoma • Neuroendocrine Tumor • Non-melanoma Skin Cancer • Oncology • Skin Cancer • Small Cell Lung Cancer • Solid Tumor • SSTR • SSTR2

Key Upcoming Milestones: (Yahoo Finance) - "Crinetics expects to initiate a Phase 1/2 dose escalation study for CRN09682, the first candidate from the nonpeptide drug conjugate (NDC) platform with an expansion phase for the treatment of metastatic or locally advanced SST2-positive neuroendocrine tumors (NETs) and other SST2-expressing solid tumors."

New P1/2 trial • Neuroendocrine Tumor • Solid Tumor

BRAVESST2: A Study to Investigate Safety and Effectiveness of CRN09682 in Participants With SST2-Expressing NENs and Other Solid Tumors (clinicaltrials.gov) - P1/2 | N=150 | Not yet recruiting | Sponsor: Crinetics Pharmaceuticals Inc.

New P1/2 trial • Endocrine Cancer • Neuroendocrine Carcinoma • Neuroendocrine Tumor • Oncology • Solid Tumor

A novel nonpeptide drug conjugate (NDC) for the treatment of somatostatin receptor 2-expressing tumours (ENETS 2025) - "CONCLUSION These data demonstrate the potent anti-tumour activity of CRN09682, a first-in-class NDC targeting SST2-expressing solid tumours. CRN09682 could provide a novel treatment alternative and is expected to enter a Phase I clinical trial in 2025."

Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • SSTR • SSTR2

A Novel Nonpeptide Drug Conjugate (NDC) for the Treatment of Somatostatin Receptor 2-Expressing Tumors (NANETS 2024) - "CRN09682 could provide a novel alternative for the treatment of NETs and other SST2-expressing tumors. CRN09682 is expected to enter a Phase I clinical trial in 2025."

Brain Cancer • Breast Cancer • CNS Tumor • Endocrine Cancer • Lung Cancer • Melanoma • Meningioma • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor • Thyroid Gland Carcinoma • SSTR • SSTR2

"Paltusotine and CRN09682: Novel NonPeptide Approaches to Treating Carcinoid Syndrome and Neuroendocrine Tumors" (NANETS 2024) - "sponsored by Crinetics."

Carcinoid Syndrome • Endocrine Cancer • Neuroendocrine Tumor • Oncology • Solid Tumor

UPDATE: Crinetics Pharmaceuticals to Showcase Pipeline Advancements with Neuroendocrine Tumor Candidates at The North American Neuroendocrine Tumor Society (NANETS) Annual Meeting (GlobeNewswire) - "...'We are excited to present preclinical data from our groundbreaking nonpeptide drug conjugate platform for our lead candidate CRN09682, an investigational anti-tumor therapy targeting SST2-expressing tumors, including NETs'....Preclinical data to be presented at NANETS 2024 demonstrate the potent and selective anti-tumor activity of CRN09682, potentially providing a novel alternative for the treatment of NETs and other SST2-expressing tumors."

Preclinical • Neuroendocrine Tumor

Crinetics Pharmaceuticals to Showcase Pipeline Advancements with Neuroendocrine Tumor Candidates at The North American Neuroendocrine Tumor Society (NANETS) Annual Meeting (GlobeNewswire) - "Novel Nonpeptide Drug Conjugate Platform to be Debuted, Featuring Preclinical Profile of Lead Candidate CRN09682 Targeting SST2-Expressing Tumors, which is on Track for IND Submission Early 2025."

IND • Carcinoid Syndrome • Carcinoid Tumor • Neuroendocrine Tumor • Oncology • Solid Tumor

Crinetics Pharmaceuticals to Showcase Pipeline Advancements with Neuroendocrine Tumor Candidates at The North American Neuroendocrine Tumor Society (NANETS) Annual Meeting (GlobeNewswire) - "Preclinical data to be presented at NANETS 2024 demonstrate the potent and selective anti-tumor activity of CRN09682, potentially providing a novel alternative for the treatment of NETs and other SST2-expressing tumors. Another abstract will be featured as both an oral and poster presentation, which includes follow-up from an open-label Phase 2 carcinoid syndrome study of investigational candidate paltusotine, a once-daily, oral, nonpeptide, selective SST2 agonist being developed for the treatment of acromegaly and carcinoid syndrome. The NANETS presentation includes findings from all 36 trial participants, with new analyses that show paltusotine reduced the frequency and severity of carcinoid syndrome symptoms and was well tolerated, justifying further clinical development."

P2 data • Preclinical • Carcinoid Syndrome • Neuroendocrine Tumor • Oncology • Solid Tumor