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PRO1184 para tumores sólidos avanzados (RAINFOL-01)

2 de noviembre de 2026 actualizado por: Genmab

Estudio de fase 1/2 de PRO1184 en pacientes con tumores sólidos localmente avanzados y/o metastásicos

This study will test the safety, including side effects, and determine the characteristics of a drug called Rina-S in participants with solid tumors.

Participants will have solid tumor cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable).

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

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) monotherapy cohort

Part D: combination therapy cohorts

Part E: a monotherapy PROC cohort

Parts F and G: a monotherapy endometrial cancer (EC) cohort

Part H: a monotherapy PROC cohort

Part I: platinum-sensitive ovarian cancer (PSOC) cohort

Part J: a monotherapy PROC cohort

Part K: a monotherapy high-grade ovarian cancer cohort

Part L: a drug-drug interaction substudy

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

952

Fase

  • Fase 2
  • Fase 1

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

  • Corea del Sur
      • Seoul, Corea del Sur
        • Reclutamiento
        • Korea Institute of Radiological and Medical Sciences
  • Estados Unidos
    • Arizona
      • Phoenix, Arizona, Estados Unidos, 85016
        • Reclutamiento
        • USOR HonorHealth
      • Tucson, Arizona, Estados Unidos, 85711
        • Reclutamiento
        • USOR Arizona Oncology Associates
    • California
      • Los Angeles, California, Estados Unidos, 90095
        • Reclutamiento
        • University of California Los Angeles Medical Center
      • San Diego, California, Estados Unidos, 92093
        • Reclutamiento
        • University of California, San Diego; Moores Cancer Center
      • Santa Barbara, California, Estados Unidos, 93105
        • Reclutamiento
        • USOR Sansum Clinic
      • Santa Rosa, California, Estados Unidos, 95403
        • Reclutamiento
        • Providence Medical Foundation
    • Florida
      • Fort Myers, Florida, Estados Unidos, 33908
        • Reclutamiento
        • USOR Florida Cancer Specialists South
      • St. Petersburg, Florida, Estados Unidos, 33709
        • Reclutamiento
        • USOR Florida Cancer Specialists North
      • West Palm Beach, Florida, Estados Unidos, 33401
        • Reclutamiento
        • USOR Florida Cancer Specialists East
    • Georgia
      • Augusta, Georgia, Estados Unidos, 30912
        • Reclutamiento
        • Augusta University Georgia Cancer Center
    • Kansas
      • Westwood, Kansas, Estados Unidos, 66205
        • Reclutamiento
        • University of Kansas Medical Center (KUMC)
    • Maryland
      • Rockville, Maryland, Estados Unidos, 20850
        • Reclutamiento
        • USOR Maryland Oncology Hematology
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02114
        • Reclutamiento
        • Massachusetts General Hospital
      • Boston, Massachusetts, Estados Unidos, 02215
        • Reclutamiento
        • Dana Farber Cancer Institute
    • Michigan
      • Detroit, Michigan, Estados Unidos, 48085
        • Reclutamiento
        • Karmanos Cancer Institute
      • Grand Rapids, Michigan, Estados Unidos, 49503
        • Reclutamiento
        • START Midwest
    • Minnesota
      • Maplewood, Minnesota, Estados Unidos, 55109
        • Reclutamiento
        • USOR Minnesota Oncology Hematology
    • New Jersey
      • Camden, New Jersey, Estados Unidos, 08103
        • Reclutamiento
        • MD Anderson Cancer Center at Cooper- Two Cooper Plaza
    • Ohio
      • Columbus, Ohio, Estados Unidos, 43210
        • Reclutamiento
        • Ohio State University Comprehensive Cancer Center (OSUCCC)- The James Cancer Hospital and Solove Research Institute
    • Oklahoma
      • Oklahoma City, Oklahoma, Estados Unidos, 73104
        • Reclutamiento
        • University of Oklahoma - Health Sciences Center
    • Oregon
      • Eugene, Oregon, Estados Unidos, 97401
        • Reclutamiento
        • USOR Oncology Associates of Oregon, P.C.
      • Portland, Oregon, Estados Unidos, 97227
        • Reclutamiento
        • Compass Oncology - Rose Quarter
    • Pennsylvania
      • Doylestown, Pennsylvania, Estados Unidos, 18901
        • Reclutamiento
        • USOR Alliance Cancer Specialist
      • Pittsburgh, Pennsylvania, Estados Unidos, 15224
        • Reclutamiento
        • Allegheny Health Network
    • Rhode Island
      • Providence, Rhode Island, Estados Unidos, 02905
        • Reclutamiento
        • Women and Infants Hospital of Rhode Island
    • Tennessee
      • Nashville, Tennessee, Estados Unidos, 37203
        • Reclutamiento
        • Tennessee Oncology
      • Nashville, Tennessee, Estados Unidos, 37203
        • Reclutamiento
        • Sarah Cannon Research Institute at Tennessee Oncology
    • Texas
      • Abilene, Texas, Estados Unidos, 79606
        • Reclutamiento
        • USOR Texas Oncology
      • Austin, Texas, Estados Unidos, 78758
        • Reclutamiento
        • Texas Oncology - Central / South Texas
      • Dallas, Texas, Estados Unidos, 75521
        • Reclutamiento
        • Mary Crowley Cancer Research
      • Fort Worth, Texas, Estados Unidos, 76104
        • Reclutamiento
        • USOR Texas Oncology
      • Tyler, Texas, Estados Unidos, 75702
        • Reclutamiento
        • Texas Oncology - Northeast TX
      • Woodland, Texas, Estados Unidos, 77380
        • Reclutamiento
        • USOR Texas Oncology Gulf Coast
    • Utah
      • West Valley City, Utah, Estados Unidos, 84119
        • Reclutamiento
        • START Mountain Region
    • Virginia
      • Fairfax, Virginia, Estados Unidos, 22031
        • Reclutamiento
        • USOR Virginia Cancer Specialists
      • Norfolk, Virginia, Estados Unidos, 23502
        • Reclutamiento
        • USOR Virginia Oncology Associates
    • Washington
      • Everett, Washington, Estados Unidos, 98104
        • Reclutamiento
        • Swedish Cancer Institute
  • Japón
    • Fukushima
      • Fukushima, Fukushima, Japón
        • Reclutamiento
        • Fukushima Medical University Hospital
    • Gunma
      • Ōta, Gunma, Japón
        • Reclutamiento
        • Gunma Prefectural Cancer Center
    • Hokkaido
      • Sapporo, Hokkaido, Japón
        • Reclutamiento
        • Sapporo Medical University Hospital
    • Hyōgo
      • Akashi, Hyōgo, Japón
        • Reclutamiento
        • Hyogo Cancer Center
    • Saitama
      • Hidaka, Saitama, Japón
        • Reclutamiento
        • Saitama Medical University-International Medical Center
    • Shizuoka
      • Nagaizumi-chō, Shizuoka, Japón
        • Reclutamiento
        • Shizuoka Cancer Center
    • Tokyo
      • Koto, Tokyo, Japón
        • Reclutamiento
        • Cancer Institute Hospital of JFCR
      • Shinjuku-ku, Tokyo, Japón
        • Reclutamiento
        • Keio University Hospital
    • Yamagata
      • Yamagata, Yamagata, Japón
        • Reclutamiento
        • Yamagata University Hospital
  • Porcelana
    • Beijing Municipality
      • Beijing, Beijing Municipality, Porcelana
        • Reclutamiento
        • Cancer hospital, Chinese Academy of Medical Sciences
    • China
      • Fujian, China, Porcelana
        • Reclutamiento
        • Fujian Cancer Hospital
      • Guangdong, China, Porcelana
        • Reclutamiento
        • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
      • Henan, China, Porcelana
        • Reclutamiento
        • Second Affiliated Hospital of Zhengzhou University
      • Hubei, China, Porcelana
        • Reclutamiento
        • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
      • Shanxi, China, Porcelana
        • Reclutamiento
        • Second Hospital of Shanxi Medical University
      • Shanxi, China, Porcelana
        • Reclutamiento
        • Shanxi Cancer Hospital
      • Shengyang, China, Porcelana
        • Reclutamiento
        • Liaoning Cancer Hospital & Institute
      • Tianjin, China, Porcelana
        • Reclutamiento
        • Tianjin Cancer Hospital
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, Porcelana
        • Reclutamiento
        • Chongqing University Cancer Hospital
    • Hunan
      • Changsha, Hunan, Porcelana
        • Reclutamiento
        • Hunan Cancer Hospital - Phase 1
      • Changsha, Hunan, Porcelana
        • Reclutamiento
        • Hunan Cancer Hospital - Thoracic Medicine Dept II
    • Jiangxi
      • Nanchang, Jiangxi, Porcelana
        • Reclutamiento
        • Jiangxi Maternal and Child Health Hospital
    • Jilin
      • Changchun, Jilin, Porcelana
        • Reclutamiento
        • Jilin Cancer Hospital
    • Shanghai Municipality
      • Chengdu, Shanghai Municipality, Porcelana
        • Reclutamiento
        • Obstetrics & Gynecology Hospital of Fudan University
      • Shanghai, Shanghai Municipality, Porcelana
        • Reclutamiento
        • Fudan University Shanghai Cancer Center - Gynecologic Oncology
      • Shanghai, Shanghai Municipality, Porcelana
        • Reclutamiento
        • Fudan University Shanghai Cancer Center- Phase 1
      • Shanghai, Shanghai Municipality, Porcelana
        • Reclutamiento
        • Shanghai East Hospital
    • Sichuan
      • Shanghai, Sichuan, Porcelana
        • Reclutamiento
        • Sichuan Cancer Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, Porcelana
        • Reclutamiento
        • Zhejiang Cancer Hospital

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

Part A and B:

  • Histologically or cytologically confirmed metastatic or unresectable solid malignancy including ovarian cancer (must have epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer), endometrial cancer, non-small cell lung cancer (Part A), EGFR-mutated NSCLC (Part B), breast cancer (hormone receptor positive, HER2-negative and triple-negative) (Part A), mesothelioma or cervical cancer (Part B).
  • Previously received therapies known to confer clinical benefit.
  • Measurable disease per RECIST v1.1 for all tumor types other than pleural mesothelioma which will use mRECIST v1.1 at baseline.

Part C, E, and H:

Participants must have histologically or cytologically confirmed metastatic or unresectable epithelial ovarian cancer as specified below.

  • High grade serous ovarian cancer, primary peritoneal cancer, or fallopian tube cancer (excluding endometrioid, clear cell carcinomas, mucinous, low grade, and those with a sarcomatous or neuroendocrine element)
  • Participants must have received up to 3 prior lines of therapy. Participants may have had up to to 4 prior lines of therapy are allowed if MIRV is locally approved and was used as the last line of therapy. Participants must have progressed radiographically on or after their most recent line of therapy.
  • Participants must have platinum-resistant ovarian cancer.
  • Participants must have received prior bevacizumab or approved biosimilar.
  • Participants with known or suspected deleterious germline or somatic BRCA mutations (as determined by Food and Drug Administration [FDA]-approved test in a Clinical Laboratory Improvement Amendments [CLIA]-certified laboratory; or locally approved equivalent) and who achieved a complete or partial response to platinum-based chemotherapy must have been treated with a poly ADP-ribose polymerase (PARP) inhibitor as maintenance treatment.
  • Measurable disease per the RECIST v1.1 at baseline.

Part D:

Cohort D1:

  • Participants must have platinum-sensitive ovarian cancer.
  • Participants must have received 1 to 3 prior lines of therapy.

Cohort D2:

  • Participants must have primary platinum-refractory, platinum-resistant, or platinum-sensitive ovarian cancer.

  • Participants with primary platinum-refractory ovarian cancer must have received ≤2 prior lines of therapy. Primary platinum-refractory ovarian cancer is defined as a lack of response or by progression within 91 days after completing front-line platinum containing therapy.

  • Participants must have received 1 to 3 prior lines of therapy for platinum-resistant ovarian cancer (PROC), and up to 4 prior lines of therapy for platinum-sensitive ovarian cancer (PSOC). Prior treatments may have included bevacizumab, PARP inhibitor, and MIRV.

    • Participants with PSOC must have disease progression on or after maintenance treatment, or at least 6 months (>183 days) or more from the last dose of platinum-based therapy.

Cohort D3:

• Endometrial cancer (any subtype excluding sarcoma).

Cohort D4:

• Primary advanced or recurrent endometrial cancer (any subtype excluding sarcoma and neuroendocrine tumors).

Cohort D5

• Primary advanced or recurrent endometrial cancer (any subtype excluding sarcoma and neuroendocrine tumors).

Part F and G:

  • Participants must have histologically or cytologically confirmed EC.
  • Recurrent progressive EC (any subtype excluding neuroendocrine tumors, carcinosarcoma, or endometrial sarcoma) following prior therapy.
  • Participants must have received 1 to 3 prior lines of therapy, and must have progressed radiographically on or after their most recent line of therapy:
  • Participants must have received prior platinum-based chemotherapy and a programmed death-ligand 1 (PD-[L])1 inhibitor.
  • Participants who progress >12 months after completion of prior adjuvant or neoadjuvant platinum-based chemotherapy must receive 1 additional cytotoxic systemic treatment prior to enrollment in this study.
  • Hormonal therapy alone (i.e., without chemotherapy) will not be counted as a separate line of therapy.
  • Measurable disease per the RECIST Version 1.1 at baseline.

Part I:

  • Participants must have histologically or cytologically confirmed high grade serous or endometrioid epithelial ovarian cancer, fallopian tube cancer and primary peritoneal cancer (excluding clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies or low grade/borderline ovarian tumors).
  • Participants must have platinum sensitive ovarian cancer.
  • Measurable disease per the RECIST Version 1.1 at baseline.

Part J:

  • Participants must have high grade epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer including serous, endometrioid, and clear cell carcinomas, and excluding mucinous, low grade, and those with a sarcomatous or neuroendocrine element.
  • Measurable disease per the RECIST Version 1.1 at baseline.

Part K:

  • Participants must have histologically or cytologically confirmed metastatic or unresectable ovarian cancer (must have high grade epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer including serous, endometrioid, and clear cell carcinomas, and excluding mucinous, low grade, and those with a sarcomatous or neuroendocrine element).
  • Participants must have primary platinum-refractory, platinum-resistant, or platinum-sensitive ovarian cancer.
  • Measurable disease per the RECIST Version 1.1 at baseline.

Part L:

  • Participants must have a histologically or cytologically confirmed metastatic or unresectable solid malignancy. Participants must have previously received all therapies known to confer clinical benefit (unless ineligible to receive or refused to receive or therapy is unavailable in the region). If a standard-of-care therapy is available that has not been administered, the reason that the therapy is not appropriate must be documented.
  • Participants must either have ovarian cancer (must have high grade epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer including serous, endometrioid, and clear cell carcinomas, and excluding mucinous, low grade, and those with a sarcomatous or neuroendocrine element), or
  • NSCLC.
  • Age 18 to 65 years (inclusive).
  • An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
  • Measurable disease per the RECIST version 1.1 at baseline.

Exclusion Criteria:

  • History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids within the past 2 years, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
  • Prior therapy with a topoisomerase 1 inhibitor-based antibody drug conjugate.

Note: Other protocol-defined inclusion/exclusion may apply.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación Secuencial
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Part A, B, C, E, F, G, H, I, J and K

Rina-S monotherapy in Part A and at the recommended dose in Parts B, C, E, F, G, H, I, J and K.
Droga: Rina-S

Intravenous infusion of Rina-S

Otros nombres:
  • PRO1184
  • GEN1184
  • Rinatabart sesutecan
Experimental: Part D1

Rina-S in combination with carboplatin
Droga: Rina-S

Intravenous infusion of Rina-S

Otros nombres:
  • PRO1184
  • GEN1184
  • Rinatabart sesutecan
Droga: Carboplatin

Carboplatin intravenous infusion
Experimental: Part D2 and I

Rina-S in combination with bevacizumab
Droga: Rina-S

Intravenous infusion of Rina-S

Otros nombres:
  • PRO1184
  • GEN1184
  • Rinatabart sesutecan
Droga: Bevacizumab

Bevacizumab intravenous infusion
Experimental: Part D3, D4 and D5

Rina-S in combination with pembrolizumab
Droga: Rina-S

Intravenous infusion of Rina-S

Otros nombres:
  • PRO1184
  • GEN1184
  • Rinatabart sesutecan
Droga: Pembrolizumab

Pembrolizumab intravenous infusion
Experimental: Part L

Rina-S in combination with CYP3A4 inhibitors erythromycin or itraconazole.
Droga: Rina-S

Intravenous infusion of Rina-S

Otros nombres:
  • PRO1184
  • GEN1184
  • Rinatabart sesutecan
Droga: Erythromycin

Erythromycin oral administration

Droga: Itraconazole

Itraconazole oral administration

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Partes A, B y D - Incidencia de eventos adversos emergentes de tratamiento (TEAES) [Seguridad y tolerabilidad]
Periodo de tiempo: Hasta el final del tratamiento, hasta aproximadamente 1 año.
Hasta el final del tratamiento, hasta aproximadamente 1 año.
Parte K (solo participantes estadounidenses): número de participantes con cambios clínicamente significativos en los hallazgos de electrocardiograma (ECG) por Holter
Periodo de tiempo: Ciclos 1 a 3 (cada ciclo es de 21 días)
Ciclos 1 a 3 (cada ciclo es de 21 días)
Parts A, and D - Number of Participants with Dose Limiting Toxicity (DLT)
Periodo de tiempo: At the end of Cycle 1 (each cycle is 21 days)
At the end of Cycle 1 (each cycle is 21 days)
Parts C, E, F, G, H, I, and J- Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review (BICR, Parts C and F) or Investigator (Part E, G, I, and J) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Periodo de tiempo: Through end of treatment, up to approximately 1 year.

Participants who achieve partial response (PR) or complete response (CR) per RECIST v1.1 criteria.
Through end of treatment, up to approximately 1 year.
Part L - Peak Plasma Concentration (Cmax) of Rina-S
Periodo de tiempo: Cycles 1 and 2 (each cycle is 21 days)

Measurement of maximum plasma concentration after the administration of Rina-S.[
Cycles 1 and 2 (each cycle is 21 days)
Part L - Area Under the Plasma Concentration Versus Time Curve (AUC) of Rina-S
Periodo de tiempo: Cycles 1 and 2 (each cycle is 21 days)

Measurement of AUC after the administration of Rina-S.
Cycles 1 and 2 (each cycle is 21 days)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Parts A, B, D, and E -Time to Reach Cmax (Tmax) for Rina-S
Periodo de tiempo: Through end of treatment, up to approximately 1 year
Through end of treatment, up to approximately 1 year
Parts A, B, D, and E - Trough Concentrations (Ctrough) for Rina-S
Periodo de tiempo: Through end of treatment, up to approximately 1 year
Through end of treatment, up to approximately 1 year
Parts A, B, D, and E- Apparent Terminal Half-life (t1/2) for Rina-S
Periodo de tiempo: Through end of treatment, up to approximately 1 year
Through end of treatment, up to approximately 1 year
Parts C, D, E, H and J - CA-125 Response Determined Using the Gynecologic Cancer Intergroup (GCIG) Criteria
Periodo de tiempo: Through end of treatment, up to approximately 1 year
Through end of treatment, up to approximately 1 year
Part E - Number of Participants With Antidrug Antibodies (ADA)
Periodo de tiempo: Through end of treatment, up to approximately 1 year
Through end of treatment, up to approximately 1 year
Parts A, B, and D - Best Overall Response (BOR)
Periodo de tiempo: Up to approximately 1 year.

Participants who achieve CR or PR. Best response as assessed by the investigator per RECIST v1.1 criteria for all tumor types other than pleural mesothelioma which will use modified RECIST (mRECIST) v1.1.
Up to approximately 1 year.
Parts A, B, D, and E - ORR
Periodo de tiempo: Up to approximately 1 year.

Participants who achieve PR or CR per RECIST v1.1 criteria.
Up to approximately 1 year.
Parts A, B, and D - Disease Control Rate (DCR)
Periodo de tiempo: Up to approximately 1 year.

Participants who achieve stable disease, PR or CR per RECIST v1.1 criteria.
Up to approximately 1 year.
Parts A, B, C, D, E, F, G, H, I, and J - Progression-Free Survival (PFS)
Periodo de tiempo: Through end of treatment, up to approximately 1 year.

Time from start of treatment to first documented disease progression or death
Through end of treatment, up to approximately 1 year.
Parts C, E, F, G, H, I and J - Overall survival (OS)
Periodo de tiempo: Up to approximately 2 years.

Time from the start of study treatment to the date of death from any cause
Up to approximately 2 years.
Parts A, B, C, D, E, F, G, H, I and J - Duration of Objective Response (DOR)
Periodo de tiempo: From date of enrollment until the date of first documented disease progression or date of study withdrawal, whichever came first, assessed up to 12 months.

Time from the first documentation of an objective tumor response (CR or PR) to the first documented tumor progression or death
From date of enrollment until the date of first documented disease progression or date of study withdrawal, whichever came first, assessed up to 12 months.
Parts A, B, D, and E - Cmax for Rina-S
Periodo de tiempo: Through end of treatment, up to approximately 1 year.

Measurement of maximum plasma concentration after the administration of Rina-S.
Through end of treatment, up to approximately 1 year.
Parts A, B, D, and E - AUC for Rina-S
Periodo de tiempo: Through end of treatment, up to approximately 1 year.

Measurement of AUC after the administration of Rina-S.
Through end of treatment, up to approximately 1 year.
Parts C, E, F, G, H, I, J, K and L - Number of Participants with Type, Incidence, Severity, Seriousness as per Common Terminology Criteria for Adverse Events (CTCAE) v5.0, and Relatedness of Adverse Events (AEs)
Periodo de tiempo: Through end of treatment, up to approximately 1 year
Through end of treatment, up to approximately 1 year
Part L - Number of Participants with DLT
Periodo de tiempo: At the end of Cycle 1 (each cycle is 21 days)
At the end of Cycle 1 (each cycle is 21 days)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Genmab

Investigadores

  • Director de estudio: Study Official, Genmab

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

7 de diciembre de 2022

Finalización primaria (Estimado)

1 de diciembre de 2028

Finalización del estudio (Estimado)

1 de marzo de 2029

Fechas de registro del estudio

Enviado por primera vez

4 de octubre de 2022

Primero enviado que cumplió con los criterios de control de calidad

11 de octubre de 2022

Publicado por primera vez (Actual)

13 de octubre de 2022

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

4 de noviembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

2 de noviembre de 2026

Última verificación

1 de octubre de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • GCT1184-01
  • PRO1184-001 (Otro identificador: Other Sponsor Identifier)
  • CTR20230813 (Identificador de registro: Chinadrugtrials.org.cn)
  • jRCT2051250094 (Identificador de registro: Japan Registry for Clinical Trials (jRCT))

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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