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CRN09682

Phase 1

SST2-positive Neuroendocrine Neoplasms | Small molecule | Oncology |Crinetics Pharmaceuticals, Inc.|Last Updated: May 11, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment150
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07129252A Study to Investigate Safety and Effectiveness of CRN09682 in Participants With SST2-Expressing NENs and Other Solid TumorsPHASE1 RECRUITING 150 — — Nov 26, 2025Aug 1, 2029May 11, 202624 United States, Spain
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Study Endpoints
Primary Endpoints
(Dose Escalation) Incidence and severity of DLTs.
From first dose through Day 21.
(Dose Escalation) Incidence and severity of AEs and SAEs at each dose level and incidence of AEs leading to discontinuation from study drug.
From first dose of study drug to 30 days after the last dose.
(Dose Expansion) Nature, incidence, and severity of AEs and SAEs at the Expansion Dose.
From first dose of study drug to 30 days after the last dose.
(Dose Expansion) Interruptions at the Expansion Dose.
At Day 1 of each cycle through study completion, approximately 2 years.
Secondary Endpoints
(Dose Escalation) Maximum Plasma Concentration (Cmax) of CRN09682 and MMAE .
Day 1 of each cycle (each cycle is 21 days) for the duration of the study, from baseline to safety follow-up visit, up to 2 years.
(Dose Escalation) Time to Maximum Concentration (Tmax) of CRN09682 and MMAE.
Day 1 of each cycle (each cycle is 21 days) for the duration of the study, from baseline to safety follow-up visit, up to 2 years.
(Dose Escalation) Measure of CRN09682 and MMAE exposure in the body from initial dose to the last measurable concentration (AUC0-last).
Day 1 of each cycle (each cycle is 21 days) for the duration of the study, from baseline to safety follow-up visit, up to 2 years.
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Dose EscalationEXPERIMENTALMultiple Dose Levels administered Q3W
Dose Expansion: Cohort 1EXPERIMENTALPancreatic Neuroendocrine Tumor (NET)
Dose Expansion: Cohort 2EXPERIMENTALNon-Pancreatic NET
Dose Expansion: Cohort 3EXPERIMENTALNeuroendocrine Carcinoma (NEC)
Dose Expansion: Cohort 4EXPERIMENTALOther Solid Tumors
Interventions
NameTypeDescription
CRN09682DRUGStudy drug CRN09682 intravenously
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites24

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 im...

Countries:United StatesSpain
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07129252primaryCompletionDate: changed
LOWMay 24, 2026NCT07129252studyFirstPostDate: changed