--- title: "Advanced Solid Tumors RAINFOL-01 | Sutter Health" description: "Phase 1/2 Study of Rina-S in Patients With Locally Advanced and/or Metastatic Solid Tumors" url: "https://www.sutterhealth.org/research/clinical-trials/advanced-solid-tumors-rainfol-01-2023025237" --- 1. [Home](https://www.sutterhealth.org/) / 2. [Research](https://www.sutterhealth.org/research) / 3. [Clinical trials](https://www.sutterhealth.org/research/clinical-trials) / 4. Advanced Solid Tumors RAINFOL-01 # Advanced Solid Tumors RAINFOL-01 **Status:** Open to Enrollment [Email us to enroll](https://www.sutterhealth.org/research/clinical-trials/advanced-solid-tumors-rainfol-01-2023025237#enroll) #### Study details View study details on [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05579366). #### Locations - Santa Barbara #### Clinical trial FAQs Information for patients and study volunteers, including [frequently asked questions](https://www.sutterhealth.org/research/faqs). This is a Phase 1/2 study of Rina-S; also known as GEN1184, formerly known as PRO1184, a folate receptor alpha (FRα) targeted antibody-drug conjugate, to evaluate the safety, tolerability, pharmacokinetics (PK), and antitumor activity of Rina-S in participants with selected locally advanced and/or metastatic solid tumors, including epithelial ovarian cancer, endometrial cancer, breast cancer, non-small cell lung cancer, and mesothelioma. The study consists of multiple parts: Part A: monotherapy cohorts Part B: tumor-specific monotherapy dose-expansion cohorts Part C: platinum-resistant ovarian cancer (PROC) cohort Part D: combination therapy cohorts Part F: a monotherapy endometrial cancer cohort Participants will continue to receive study treatment until the first instance of disease progression, unacceptable toxicity, investigator decision, consent withdrawal, study termination by the Sponsor, pregnancy, or death. ![Ryan F Kendle, M.D.](https://dyn.mktgcdn.com/p/fInGQv_TRDB4JhwaTOxRwCB0VwzApOiq_OsGSzkVSPs/fit=crop,gravity=auto,dpr=2,width=188,height=250,quality=100) Ryan F Kendle, M.D. Principal investigator [View profile](https://www.sutterhealth.org/research/investigators/ryan-f-kendle-md-2022827482) ## Email us to enroll - [Email Santa Barbara](mailto:ClinicalResearch%40sutterhealth.org?subject=More%20information%20on%20Advanced%20Solid%20Tumors%20RAINFOL-01%20in%20Santa%20Barbara&body=Please%20be%20aware%20that%20if%20you%20reply%20with%20unencrypted%20email%2C%20this%20increases%20the%20risk%20that%20information%20could%20be%20read%20by%20an%20unauthorized%20third%20party.%20Please%20do%20not%20include%20any%20Protected%20Health%20Information%20in%20your%20email%20response.) ## Related clinical trials [View all clinical trials](https://www.sutterhealth.org/research-search-results?verticalKey=clinical_trial) - 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Clinical trial ### [Adjuvant Breast Cancer ER-pos/HER2-neg EA1242](https://www.sutterhealth.org/research/clinical-trials/adjuvant-breast-cancer-er-pos-her2-neg-ea1242-2072227055) A Phase III Trial of Rx Therapy Guided by Genomic Risk Assessment for High Anatomic Stage ER-pos/HER2-neg Breast Cancer With RS≤25 (RxFINE-Low) **Status:** Open to Enrollment - Clinical trial ### [Adjuvant Breast NRG-BR009](https://www.sutterhealth.org/research/clinical-trials/adjuvant-breast-nrg-br009-1049142000) A Phase III Adjuvant Trial Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression Plus Endocrine Therapy in Premenopausal Patients With pN0-1, ER-Positive/HER2-Negative Breast Cancer and an Oncotype Recurrence Score Less Than or Equal to 25 (OFSET) **Status:** Open to Enrollment [View all clinical trials](https://www.sutterhealth.org/research-search-results?verticalKey=clinical_trial) ```json {"@context":"https://schema.org","@type":"MedicalOrganization","name":"Sutter Health","@id":"https://www.sutterhealth.org/#medicalorganization","url":"https://www.sutterhealth.org","logo":"https://www.sutterhealth.org/static/images/sutter-health-logo.svg","address":{"@type":"PostalAddress","streetAddress":"2200 River Plaza Drive","addressLocality":"Sacramento","addressRegion":"CA","postalCode":"95833","addressCountry":"US"},"areaServed":{"@type":"AdministrativeArea","name":"California"},"sameAs":["https://www.facebook.com/SutterHealth","https://www.instagram.com/sutterhealth/","https://x.com/SutterHealth","https://www.youtube.com/sutterhealth","https://www.linkedin.com/company/sutter-health","https://en.wikipedia.org/wiki/Sutter_Health"]} ``` ```json {"@context":"https://schema.org","@type":"BreadcrumbList","@id":"https://www.sutterhealth.org/research/clinical-trials/advanced-solid-tumors-rainfol-01-2023025237#breadcrumblist","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https://www.sutterhealth.org/"},{"@type":"ListItem","position":2,"name":"Research","item":"https://www.sutterhealth.org/research"},{"@type":"ListItem","position":3,"name":"Clinical trials","item":"https://www.sutterhealth.org/research/clinical-trials"},{"@type":"ListItem","position":4,"name":"Advanced Solid Tumors RAINFOL-01"}]} ``` ```json {"@context":"https://schema.org","@type":"MedicalWebPage","@id":"https://www.sutterhealth.org/research/clinical-trials/advanced-solid-tumors-rainfol-01-2023025237#medicalwebpage","name":"Advanced Solid Tumors RAINFOL-01","description":"Phase 1/2 Study of Rina-S in Patients With Locally Advanced and/or Metastatic Solid Tumors","url":"https://www.sutterhealth.org/research/clinical-trials/advanced-solid-tumors-rainfol-01-2023025237","inLanguage":"en-US","dateModified":"2026-06-08","publisher":{"@type":"MedicalOrganization","name":"Sutter Health","@id":"https://www.sutterhealth.org/#medicalorganization","url":"https://www.sutterhealth.org"},"medicalAudience":{"@type":"MedicalAudience","audienceType":"Patient"},"mainEntity":{"@id":"https://www.sutterhealth.org/research/clinical-trials/advanced-solid-tumors-rainfol-01-2023025237#medicaltrial"},"breadcrumb":{"@id":"https://www.sutterhealth.org/research/clinical-trials/advanced-solid-tumors-rainfol-01-2023025237#breadcrumblist"},"mentions":[{"@type":"Person","name":"Ryan F Kendle, M.D.","url":"https://www.sutterhealth.org/research/investigators/ryan-f-kendle-md-2022827482","jobTitle":"Principal Investigator","affiliation":{"@type":"MedicalOrganization","name":"Sutter Health","@id":"https://www.sutterhealth.org/#medicalorganization","url":"https://www.sutterhealth.org"}}]} ``` ```json {"@context":"https://schema.org","@type":"MedicalTrial","@id":"https://www.sutterhealth.org/research/clinical-trials/advanced-solid-tumors-rainfol-01-2023025237#medicaltrial","name":"Advanced Solid Tumors RAINFOL-01","alternateName":"Phase 1/2 Study of Rina-S in Patients With Locally Advanced and/or Metastatic Solid Tumors","url":"https://www.sutterhealth.org/research/clinical-trials/advanced-solid-tumors-rainfol-01-2023025237","description":"This is a Phase 1/2 study of Rina-S; also known as GEN1184, formerly known as PRO1184, a folate receptor alpha (FRα) targeted antibody-drug conjugate, to evaluate the safety, tolerability, pharmacokinetics (PK), and antitumor activity of Rina-S in participants with selected locally advanced and/or metastatic solid tumors, including epithelial ovarian cancer, endometrial cancer, breast cancer, non-small cell lung cancer, and mesothelioma. 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