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An Extension Study to Assess the Efficacy of Rina-S Compared to Treatment of Investigator's Choice in Participants With Platinum Resistant Ovarian Cancer in China (RAINFOL-02)

1. Juni 2026 aktualisiert von: Genmab

A Phase 3 Randomized, Open-label Study of Rinatabart Sesutecan (Rina-S) Versus Treatment of Investigator's Choice (IC) in Patients With Platinum Resistant Ovarian Cancer

The purpose of this Chinese extension study is to compare how well Rina-S works against platinum-resistant ovarian cancer compared to chemotherapy drugs that are already approved and used for platinum-resistant ovarian cancer.

Treatment in this study could be Rina-S or it could be 1 of 4 indicated chemotherapy agents that are considered standard medical care. There is an equal (50:50) chance of getting Rina-S or an approved chemotherapy agent as treatment in this study. No one will know what treatment they are assigned to until the first dose.

All participants will receive active drug; no one will be given placebo.

This study is an extension study of the protocol GCT1184-02 (NCT06619236).

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

82

Phase

  • Phase 3

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, China
        • Beijing Cancer hospital
      • Beijing, China
        • Peking Union Medical College Hospital
      • Chongqing, China
        • Chongqing University Cancer Hospital - Chongqing Cancer Hospital
      • Fujian, China
        • Fujian Provincial Cancer Hospital
      • Guangdong, China
        • Sun Yat-sen University Cancer Center
      • Guangdong, China
        • Sun Yat-sen Memorial Hospital
      • Heilongjiang, China
        • Harbin Medical University Cancer Hospital
      • Henan, China
        • Henan Cancer Hospital
      • Hunan, China
        • Hunan Cancer Hospital
      • Jiangsu, China
        • Nanjing Drum Tower Hospital (The Affiliated Hospital of Nanjing University Medical School)
      • Jilin, China
        • The First Hospital of Jilin University
      • Liaoning, China
        • Liaoning Cancer Hospital
      • Shandong, China
        • Shandong Cancer Hospital
      • Shanghai, China
        • Fudan University Shanghai Cancer Hospital
      • Shanghai, China
        • Obstetrics & Gynecology Hospital of Fudan University
      • Shanxi, China
        • Shanxi Cancer Hospital
      • Shanxi, China
        • The First Affiliated Hospital of Xi'an Jiaotong University
      • Sichuan, China
        • West China Second University Hospital, Sichuan University
      • Tianjin, China
        • Tianjin Medical University Cancer Institute & Hospital
      • Zhejiang, China
        • Zhejiang Cancer Hospital

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

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Key Inclusion Criteria:

  • Participants must have histologically or cytologically confirmed high grade serous or endometrioid epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
  • Participants may be enrolled regardless of FRα expression level.
  • Participants must have received 1 to 4 prior lines of therapy. Participants must have progressed radiographically on or after their most recent line of therapy.

  • Participants must have received prior treatment with the following therapies:

    • Platinum chemotherapy
    • Prior bevacizumab (or biosimilar) treatment is required, if labeled and available as standard of care per institutional guidelines, unless the participant has a documented contraindication or unless the participant is not eligible for treatment with bevacizumab (or biosimilar) due to precautions/intolerance
    • Participants with known or suspected deleterious germline or somatic breast cancer gene (BRCA) mutations 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 unless the participant is not eligible for treatment with PARP inhibitor

  • Mirvetuximab soravtansine, if:

    • Mirvetuximab soravtansine is available in the enrollment region, and
    • The participant is eligible, and
    • The participant does not have a documented medical exception, including chronic corneal disorders, history of corneal transplantation, or active ocular conditions requiring ongoing treatment/monitoring, such as uncontrolled glaucoma, wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, macular degeneration, presence of papilledema, and /or monocular vision.

  • Participants must have platinum-resistant disease:

    • Participants who have only had 1 line of platinum-based therapy must have received at least 4 cycles of platinum therapy, and must have either had a response (CR or PR) or had non-measurable disease at the start of adjuvant platinum-based therapy, and then progressed between > 91 days and ≤ 183 days after the date of the last dose of platinum.
    • Participants who have received a protocol defined number of lines of platinum-based therapy must have progressed on or within 183 days after the date of the last dose of platinum.

Key Exclusion Criteria:

  • Prior therapy with an antibody-drug conjugate containing a topoisomerase 1 inhibitor.
  • Have primary platinum-refractory disease, defined as ovarian cancer that did not respond (CR or PR) to or progressed ≤ 91 days after the last dose of a first-line platinum-containing regimen.
  • History of another malignancy within 3 years before the first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death (e.g., 5-year OS ≥90%), including, but not limited to, adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, ductal carcinoma in situ, or Stage I uterine cancer.
  • Known active central nervous system metastases or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are clinically stable for at least 4 weeks prior to study entry after brain metastasis treatment, they have no new or enlarging brain metastases, and are off corticosteroids and anticonvulsants prescribed for symptoms associated with brain metastases for at least 7 days prior to the first dose of study drug. Participants with suspected brain metastases at screening should undergo a computed tomography (CT)/magnetic resonance imaging (MRI) of the brain prior to study entry.
  • Hospitalization or clinical symptoms due to gastrointestinal obstruction within the past 91 days or radiographic evidence of gastrointestinal obstruction at the time of screening. Enrollment of participants who currently require parenteral nutrition must be discussed with the study medical monitor to determine eligibility.
  • Participant has clinically significant ascites/pleural effusion. Enrollment of participants with an indwelling catheter flush/drain is not allowed. Note: Clinically significant is defined as (1) symptomatic, or (2) requires therapeutic paracentesis/thoracentesis within 8 weeks of the first dose, or (3) recurrent ascites/pleural effusion that necessitates multiple paracentesis/thoracocentesis procedures more often than approximately every 4 weeks.

NOTE: Other protocol-defined Inclusion/Exclusion criteria 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: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: Wahl des Ermittlers
Arzneimittel: Paclitaxel
IV-Infusion
Arzneimittel: Gemcitabin
IV-Infusion
Arzneimittel: Pegyliertes liposomales Doxorubicin (PLD)
IV-Infusion
Arzneimittel: Topotecan
IV-Infusion
Experimental: Rina-S
Arzneimittel: Rina-S
Intravenöse (IV) Infusion
Andere Namen:
  • PRO1184
  • Rinatabart Sesutecan
  • GEN1184

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Progression-Free Survival (PFS)
Zeitfenster: Up to approximately 16 months
PFS is defined as the time from the date of randomization to the date of the first documented progression or death (PD) due to any cause, whichever occurs first based on response evaluation criteria in solid tumors (RECIST) version 1.1 as assessed by the investigator.
Up to approximately 16 months

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Overall Survival (OS)
Zeitfenster: Up to approximately 25 months
OS is defined as the time from date of randomization to date of death due to any cause.
Up to approximately 25 months
Objective Response Rate (ORR)
Zeitfenster: Up to approximately 25 months
ORR is defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) based on RECIST v1.1 as assessed by the investigator.
Up to approximately 25 months
PFS as Determined by BICR
Zeitfenster: Up to approximately 16 months
PFS is defined as the time from the date of randomization to the date of the first documented progression or death (PD) due to any cause, whichever occurs first based on RECIST version 1.1 as determined by BICR.
Up to approximately 16 months
ORR as Determined by BICR
Zeitfenster: Up to approximately 25 months
ORR is defined as the percentage of participants with BOR of CR or PR based on RECIST v1.1 as determined by BICR.
Up to approximately 25 months
Duration of Response (DOR)
Zeitfenster: Up to approximately 25 months
DOR is defined as the time from the onset date of response to the date of the first documented progression or death due to any cause based on RECIST v1.1 as assessed by the investigator and by blinded independent central review (BICR).
Up to approximately 25 months
Percentage of Participants Who Achieved Cancer Antigen-125 (CA-125) Response per Gynecologic Cancer Intergroup (GCIG) Criteria
Zeitfenster: Up to approximately 25 months
A CA-125 response per the GCIG criteria is defined as a ≥ 50% reduction in CA-125 levels from baseline.
Up to approximately 25 months
Time to Second Disease Progression or Death From any Cause (PFS2)
Zeitfenster: Up to approximately 25 months
PFS2 is defined as the time from randomization to the date of the second PD (i.e., the first PD reported in subsequent anti-cancer therapies, or long-term follow up) or death.
Up to approximately 25 months
Overall Change From Baseline in Global Health Status/Quality of Life (GHS/Qol)
Zeitfenster: Baseline, up to approximately 25 months
Overall change from baseline in GHS/Qol score (items 29 and 30) will be calculated using the European Organization for Research and Treatment of Cancer Quality of Life Core 30 (EORTC-QLQ-C30) questionnaire. The score ranges from 0 to 100. A high scale score represents a higher response level.
Baseline, up to approximately 25 months
Time to Deterioration (TTD) in the GHS/Qol Score
Zeitfenster: Up to approximately 25 months
TTD in the GHS/Qol score is defined as the time from baseline to the first onset of a ≥10-point negative change (decrease) in GHS/QoL score. A longer TTD indicates a better outcome.
Up to approximately 25 months
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Zeitfenster: Up to approximately 25 months
Up to approximately 25 months

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 (Geschätzt)

1. Juni 2026

Primärer Abschluss (Geschätzt)

1. September 2027

Studienabschluss (Geschätzt)

1. Dezember 2028

Studienanmeldedaten

Zuerst eingereicht

18. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

18. Mai 2026

Zuerst gepostet (Tatsächlich)

22. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

2. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

1. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • GCT1184-02 Extension Study
  • CTR20253987 (Registrierungskennung: ChinaDrugTrials.org.cn)

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

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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