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PRO1184 für fortgeschrittene solide Tumore (RAINFOL-01)

2. November 2026 aktualisiert von: Genmab

Phase-1/2-Studie zu PRO1184 bei Patienten mit lokal fortgeschrittenen und/oder metastasierten soliden 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).

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

952

Phase

  • Phase 2
  • Phase 1

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Nicht randomisiert
  • Interventionsmodell: Sequenzielle Zuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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.
Arzneimittel: Rina-S

Intravenous infusion of Rina-S

Andere Namen:
  • PRO1184
  • GEN1184
  • Rinatabart Sesutecan
Experimental: Part D1

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

Intravenous infusion of Rina-S

Andere Namen:
  • PRO1184
  • GEN1184
  • Rinatabart Sesutecan
Arzneimittel: Carboplatin

Carboplatin intravenous infusion
Experimental: Part D2 and I

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

Intravenous infusion of Rina-S

Andere Namen:
  • PRO1184
  • GEN1184
  • Rinatabart Sesutecan
Arzneimittel: Bevacizumab

Bevacizumab intravenous infusion
Experimental: Part D3, D4 and D5

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

Intravenous infusion of Rina-S

Andere Namen:
  • PRO1184
  • GEN1184
  • Rinatabart Sesutecan
Arzneimittel: Pembrolizumab

Pembrolizumab intravenous infusion
Experimental: Part L

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

Intravenous infusion of Rina-S

Andere Namen:
  • PRO1184
  • GEN1184
  • Rinatabart Sesutecan
Arzneimittel: Erythromycin

Erythromycin oral administration

Arzneimittel: Itraconazole

Itraconazole oral administration

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Teile A, B und D - Inzidenz von Behandlungsbeteiligten unerwünschten Ereignissen (TEAEs) [Sicherheit und Verträglichkeit]
Zeitfenster: Bis zum Ende der Behandlung, bis zu ungefähr 1 Jahr.
Bis zum Ende der Behandlung, bis zu ungefähr 1 Jahr.
Teil K (nur US -Teilnehmer) - Anzahl der Teilnehmer mit klinisch signifikanten Veränderungen im Elektrokardiogramm (EKG) von Holter
Zeitfenster: Zyklen 1 bis 3 (jeder Zyklus beträgt 21 Tage)
Zyklen 1 bis 3 (jeder Zyklus beträgt 21 Tage)
Parts A, and D - Number of Participants with Dose Limiting Toxicity (DLT)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Parts A, B, D, and E -Time to Reach Cmax (Tmax) for Rina-S
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: At the end of Cycle 1 (each cycle is 21 days)
At the end of Cycle 1 (each cycle is 21 days)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Genmab

Ermittler

  • Studienleiter: Study Official, Genmab

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

7. Dezember 2022

Primärer Abschluss (Geschätzt)

1. Dezember 2028

Studienabschluss (Geschätzt)

1. März 2029

Studienanmeldedaten

Zuerst eingereicht

4. Oktober 2022

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

11. Oktober 2022

Zuerst gepostet (Tatsächlich)

13. Oktober 2022

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

4. November 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

2. November 2026

Zuletzt verifiziert

1. Oktober 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

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

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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