Clinical trial • Phase I/II • Oncology
CRN09682 for Neuroendocrine neoplasm (metastatic or locally advanced) | SST2-expressing solid tumors
Phase I/II trial of CRN09682 for Neuroendocrine neoplasm (metastatic or locally advanced) | SST2-expressing solid tumors.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Neuroendocrine neoplasm (metastatic or locally advanced) | SST2-expressing solid tumors
- Trial Stage
- Phase I/II
- Drug Modality
- ADC
Key dates
- Initial CTIS Submission Date
- 31-07-2025
- First CTIS Authorization Date
- 21-11-2025
Trial design
open-label, none/not specified-controlled, adaptive Phase I/II trial across 14 sites in Spain, France, Germany and others.
- Open Label
- Yes
- Comparator
- None/Not specified
- Adaptive
- True, dose-escalation design with selection of expansion dose(s) based on exposure–response and exposure–toxicity relationships established during dose escalation; dose-escalation cohorts used to determine expansion dose.
- Biomarker Stratified
- True, biomarker: SST2/SSR expression confirmed by SSR imaging
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 81
Eligibility
Recruits 81 adults.
Inclusion criteria
- {"criterion_text":"- Have a histological diagnosis of metastatic or locally advanced inoperable NET, NEC, or other solid tumors that have confirmed radiological progression.\n- Have one or more measurable disease location per RECIST version 1.1.\n- Have a tumor that expresses SSR confirmed by SSR imaging."}
Exclusion criteria
- {"criterion_text":"- Have tumor progression while undergoing a course of PRRT or within 6 months of completing PRRT.\n- 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.\n- Use of anticancer agents within the following intervals prior to the first dose of study drug.\n- Had any surgery, chemoembolization, or radiofrequency ablation within 90 days prior to first dose of study drug.\n- Prior participation in any intervention clinical study within 30 days or 5 half-lives (whichever is longer) prior to first dose of study drug.\n- Participants with carcinoid syndrome.\n- 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.\n- Have prior treatment with MMAE.\n- Have hypersensitivity or history of anaphylactic reaction to octreotide, other SSAs, and/or MMAE."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Dose Escalation Phase: Incidence and severity of DLTs.","definition_or_measurement_approach":""}
- {"endpoint_text":"- Dose Escalation Phase: Incidence and severity of AEs and SAEs at each dose level.","definition_or_measurement_approach":""}
- {"endpoint_text":"- Dose Escalation Phase: Incidence of AEs leading to discontinuation from study drug.","definition_or_measurement_approach":""}
- {"endpoint_text":"- Dose Expansion Phase: Nature, incidence, and severity of AEs and SAEs at the Expansion Dose.","definition_or_measurement_approach":""}
- {"endpoint_text":"- Dose Expansion Phase: Interruptions at the Expansion Dose.","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- Dose Escalation Phase: Plasma PK parameters of CRN09682, including Cmax, tmax, AUC0-last, AUC0-inf, and t½.","definition_or_measurement_approach":"Plasma PK parameters (Cmax, tmax, AUC0-last, AUC0-inf, t½) measured from plasma samples."}
- {"endpoint_text":"- Dose Escalation Phase: Plasma PK parameters of MMAE, including Cmax, tmax, and AUC0-last.","definition_or_measurement_approach":"Plasma PK parameters (Cmax, tmax, AUC0-last) measured from plasma samples."}
- {"endpoint_text":"- Dose Escalation Phase: ORR=PR+CR by RECIST version 1.1 criteria.","definition_or_measurement_approach":"Objective response rate defined as complete response (CR) or partial response (PR) per RECIST v1.1."}
- {"endpoint_text":"- Dose Escalation Phase: DOR, defined as time from achieving at least a RECIST PR to disease progression.","definition_or_measurement_approach":"Duration of response defined as time from first documented RECIST partial response (PR) or better to documented disease progression."}
- {"endpoint_text":"- Dose Escalation Phase: DCR=PR+CR+SD by RECIST version 1.1 criteria.","definition_or_measurement_approach":"Disease control rate defined as CR, PR, or stable disease (SD) per RECIST v1.1."}
- {"endpoint_text":"- Dose Escalation Phase: Safety, tolerability, PK, and response by dose level.","definition_or_measurement_approach":""}
- {"endpoint_text":"- Dose Expansion Phase: ORR=PR+CR by RECIST version 1.1 criteria.","definition_or_measurement_approach":"Objective response rate defined as CR or PR per RECIST v1.1."}
- {"endpoint_text":"- Dose Expansion Phase: DOR, defined as time from achieving at least a RECIST version 1.1 PR to disease progression.","definition_or_measurement_approach":"Duration of response per RECIST v1.1: time from documented PR or better to progression."}
- {"endpoint_text":"- Dose Expansion Phase: DCR=PR+CR+SD by RECIST version 1.1 criteria.","definition_or_measurement_approach":"Disease control rate defined as CR, PR, or SD per RECIST v1.1."}
- {"endpoint_text":"- Dose Expansion Phase: Radiographic PFS (defined as time from enrollment to disease progression).","definition_or_measurement_approach":"Radiographic progression-free survival defined as time from enrollment to documented disease progression."}
- {"endpoint_text":"- Dose Expansion Phase: Changes in somatostatin receptor imaging.","definition_or_measurement_approach":""}
- {"endpoint_text":"- Dose Expansion Phase: Plasma concentrations of CRN09682 and MMAE at predose and EOI.","definition_or_measurement_approach":"Plasma concentrations measured at predose and end of infusion (EOI)."}
Recruitment
- Digital Remote Recruitment
- True, digital/remote methods referenced in document titles include 'Scout Email communication', 'Reloadable ScoutPass Mailer', 'Scout Form' and related Scout materials (country-specific).
- Planned Sample Size
- 81
- Recruitment Window Months
- 44
- Consent Approach
- Informed consent via subject information sheets and informed consent forms (country-specific L1/L2 documents). Country-language ICFs available for Spain, Germany, Italy, France (documents L1_* in each country). Consent provided by participants (adults); additional forms include 'Pregnant Partner' and 'Optional procedure' variants.
Methods
- Dr-to-Patient letter (country-specific: ES/DE/IT/FR) - clinician-initiated patient approach (document titles: K2_*_Dr-to-Patient text).
- Study flyer / Participant brochure (country-specific: ES/DE/IT/FR) - patient-facing printed materials (document titles: K2_*_Study Flyer, K2_*_Participant Brochure).
- Scout platform materials including Scout Brochure, Scout Email communication, Scout Form, Reloadable ScoutPass Mailer/FAQs (country-specific: DE/FR) - digital outreach and pre-screening communications.
- Patient-facing materials and site policies (country-specific subject information and consent forms available per country: L1_* and L2_* documents).
Geography
- Total Number Of Sites
- 14
- Total Number Of Participants
- 62
Spain
- Earliest CTIS Part Ii Submission Date
- 21-10-2025
- Latest Decision Or Authorization Date
- 21-11-2025
- Processing Time Days
- 31
- Number Of Sites
- 4
- Number Of Participants
- 15
Sites
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Oncology
- Contact Person Name
- Rocio Garcia Carbonero
- Contact Person Email
- rgcarbonero@gmail.com
- Site Name
- Hospital Hm Nou Delfos
- Department Name
- Oncology
- Contact Person Name
- Tatiana Hernandez Guerrero
- Contact Person Email
- Tatiana.hernandez@start-barcelona.com
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Oncology
- Contact Person Name
- Manuel Pedregal Trujillo
- Contact Person Email
- Manuel.pedregal@startmadrid.com
- Site Name
- Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
- Department Name
- Oncology
- Contact Person Name
- Jorge Hernando Cubero
- Contact Person Email
- jhernando@vhio.net
France
- Earliest CTIS Part Ii Submission Date
- 18-02-2026
- Latest Decision Or Authorization Date
- 25-03-2026
- Processing Time Days
- 35
- Number Of Sites
- 3
- Number Of Participants
- 8
Sites
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Pancratology and digestive oncology
- Contact Person Name
- Louis De Mestier
- Contact Person Email
- louis.demestier@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- Digestive oncology
- Contact Person Name
- Denis Smith
- Contact Person Email
- denis.smith@chu-bordeaux.fr
- Site Name
- Institut Paoli Calmettes
- Department Name
- Medical Oncology
- Contact Person Name
- Sandrine Oziel-Taieb
- Contact Person Email
- oziels@ipc.unicancer.fr
Germany
- Earliest CTIS Part Ii Submission Date
- 09-03-2026
- Latest Decision Or Authorization Date
- 19-03-2026
- Processing Time Days
- 10
- Number Of Sites
- 3
- Number Of Participants
- 14
Sites
- Site Name
- Universitaetsklinikum Wuerzburg AöR
- Department Name
- Gastroenterology
- Contact Person Name
- Alexander Weich
- Contact Person Email
- weich_a@ukw.de
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Gastroenterology
- Contact Person Name
- Peter Steinhagen
- Contact Person Email
- peter.steinhagen@charite.de
- Site Name
- Universitaetsklinikum Heidelberg AöR
- Department Name
- Gastroenterology
- Contact Person Name
- Leonidas Apostodilis
- Contact Person Email
- Leonidas.Apostolidis@med.uni-heidelberg.de
Italy
- Earliest CTIS Part Ii Submission Date
- 23-02-2026
- Latest Decision Or Authorization Date
- 23-03-2026
- Processing Time Days
- 28
- Number Of Sites
- 4
- Number Of Participants
- 25
Sites
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- UOC Medicina Interna, Endocrinologia e Diabetologia
- Contact Person Name
- Antioni Bianchi
- Contact Person Email
- antonio.bianchi@policlinicogemelli.it
- Site Name
- Azienda Ospedaliero Universitaria Di Modena
- Department Name
- SC Oncologia
- Contact Person Name
- Annalisa Fontana
- Contact Person Email
- fontana.annalisa@aou.mo.it
- Site Name
- Centro Ricerche Cliniche Di Verona S.r.l.
- Contact Person Name
- Sara Cingarlini
- Contact Person Email
- sara.cingarlini@aovr.veneto.it
- Site Name
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
- Department Name
- UOC Oncologia Medica
- Contact Person Name
- Davide Campana
- Contact Person Email
- davide.campana@unibo.it
Sponsor
Primary sponsor
- Full Name
- Crinetics Pharmaceuticals Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- CRN09682
- Active Substance
- CRN09682
- Modality
- ADC
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- First In Human
- Yes
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