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PRO1184 voor gevorderde vaste tumoren (RAINFOL-01)

2 november 2026 bijgewerkt door: Genmab

Fase 1/2 studie van PRO1184 bij patiënten met lokaal gevorderde en/of gemetastaseerde vaste tumoren

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).

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

952

Fase

  • Fase 2
  • Fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Sequentiële toewijzing
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Geneesmiddel: Rina-S

Intravenous infusion of Rina-S

Andere namen:
  • PRO1184
  • GEN1184
  • Rinatabart sesutecan
Experimenteel: Part D1

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

Intravenous infusion of Rina-S

Andere namen:
  • PRO1184
  • GEN1184
  • Rinatabart sesutecan
Geneesmiddel: Carboplatin

Carboplatin intravenous infusion
Experimenteel: Part D2 and I

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

Intravenous infusion of Rina-S

Andere namen:
  • PRO1184
  • GEN1184
  • Rinatabart sesutecan
Geneesmiddel: Bevacizumab

Bevacizumab intravenous infusion
Experimenteel: Part D3, D4 and D5

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

Intravenous infusion of Rina-S

Andere namen:
  • PRO1184
  • GEN1184
  • Rinatabart sesutecan
Geneesmiddel: Pembrolizumab

Pembrolizumab intravenous infusion
Experimenteel: Part L

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

Intravenous infusion of Rina-S

Andere namen:
  • PRO1184
  • GEN1184
  • Rinatabart sesutecan
Geneesmiddel: Erythromycin

Erythromycin oral administration

Geneesmiddel: Itraconazole

Itraconazole oral administration

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Onderdelen A, B en D - Incidentie van bijwerkingen voor behandelingsopkomst (TEEAS) [Veiligheid en verdraagbaarheid]
Tijdsspanne: Door het einde van de behandeling, tot ongeveer 1 jaar.
Door het einde van de behandeling, tot ongeveer 1 jaar.
Deel K (alleen Amerikaanse deelnemers) - Aantal deelnemers met klinisch significante veranderingen in bevindingen van elektrocardiogram (ECG) door Holter
Tijdsspanne: Cycli 1 tot 3 (elke cyclus is 21 dagen)
Cycli 1 tot 3 (elke cyclus is 21 dagen)
Parts A, and D - Number of Participants with Dose Limiting Toxicity (DLT)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Parts A, B, D, and E -Time to Reach Cmax (Tmax) for Rina-S
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: At the end of Cycle 1 (each cycle is 21 days)
At the end of Cycle 1 (each cycle is 21 days)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Genmab

Onderzoekers

  • Studie directeur: Study Official, Genmab

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

7 december 2022

Primaire voltooiing (Geschat)

1 december 2028

Studie voltooiing (Geschat)

1 maart 2029

Studieregistratiedata

Eerst ingediend

4 oktober 2022

Eerst ingediend dat voldeed aan de QC-criteria

11 oktober 2022

Eerst geplaatst (Werkelijk)

13 oktober 2022

Updates van studierecords

Laatste update geplaatst (Werkelijk)

4 november 2026

Laatste update ingediend die voldeed aan QC-criteria

2 november 2026

Laatst geverifieerd

1 oktober 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • GCT1184-01
  • PRO1184-001 (Andere identificatie: Other Sponsor Identifier)
  • CTR20230813 (Register-ID: Chinadrugtrials.org.cn)
  • jRCT2051250094 (Register-ID: Japan Registry for Clinical Trials (jRCT))

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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