A Study to Investigate Safety and Effectiveness of CRN09682 in Participants With SST2-Expressing NENs and Other Solid Tumors (BRAVESST2)

Crinetics Pharmaceuticals

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Neuroendocrine Tumors; SST2-positive Neuroendocrine Neoplasms; Neuroendocrine Neoplasm

Treatments: Drug: CRN09682

Study type: Interventional

Funder types: Industry

Identifiers

NCT07129252

CRN09682-191

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.
• 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 design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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150 participants in 5 patient groups

Dose Escalation

Experimental group

Description:

Multiple Dose Levels administered Q3W

Treatment:

Drug: CRN09682

Dose Expansion: Cohort 1

Experimental group

Description:

Pancreatic Neuroendocrine Tumor (NET)

Treatment:

Drug: CRN09682

Dose Expansion: Cohort 2

Experimental group

Description:

Non-Pancreatic NET

Treatment:

Drug: CRN09682

Dose Expansion: Cohort 3

Experimental group

Description:

Neuroendocrine Carcinoma (NEC)

Treatment:

Drug: CRN09682

Dose Expansion: Cohort 4

Experimental group

Description:

Other Solid Tumors

Treatment:

Drug: CRN09682