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

Purpose

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.

Conditions

  • SST2-positive Neuroendocrine Neoplasms
  • Neuroendocrine Tumors
  • Neuroendocrine Neoplasm

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Intervention 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.
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Dose Escalation 		Multiple Dose Levels administered Q3W
  • Drug: CRN09682
    Study drug CRN09682 intravenously
Experimental
Dose Expansion: Cohort 1 		Pancreatic Neuroendocrine Tumor (NET)
  • Drug: CRN09682
    Study drug CRN09682 intravenously
Experimental
Dose Expansion: Cohort 2 		Non-Pancreatic NET
  • Drug: CRN09682
    Study drug CRN09682 intravenously
Experimental
Dose Expansion: Cohort 3 		Neuroendocrine Carcinoma (NEC)
  • Drug: CRN09682
    Study drug CRN09682 intravenously
Experimental
Dose Expansion: Cohort 4 		Other Solid Tumors
  • Drug: CRN09682
    Study drug CRN09682 intravenously

Recruiting Locations

Crinetics Study Site
Newport Beach 5376890, California 5332921 92663

Crinetics Study Site
Denver 5419384, Colorado 5417618 80218

Crinetics Study Site
Grand Rapids 4994358, Michigan 5001836 49503

Crinetics Study Site
Austin 4671654, Texas 4736286 78758

Crinetics Study Site
Irving 4700168, Texas 4736286 75039

Crinetics Study Site
Fairfax 4758023, Virginia 6254928 22031

More Details

Status
Recruiting
Sponsor
Crinetics Pharmaceuticals Inc.

Study Contact

Crinetics Clinical Trials
833-276-4636
clinicaltrials@crinetics.com