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PRO1184 dla zaawansowanych guzów litych (RAINFOL-01)

2 listopada 2026 zaktualizowane przez: Genmab

Badanie fazy 1/2 PRO1184 u pacjentów z miejscowo zaawansowanymi i/lub przerzutowymi guzami litymi

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).

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

952

Faza

  • Faza 2
  • Faza 1

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Nielosowe
  • Model interwencyjny: Zadanie sekwencyjne
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Lek: Rina-S

Intravenous infusion of Rina-S

Inne nazwy:
  • PRO1184
  • GEN1184
  • Rinatabart sesutecan
Eksperymentalny: Part D1

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

Intravenous infusion of Rina-S

Inne nazwy:
  • PRO1184
  • GEN1184
  • Rinatabart sesutecan
Lek: Carboplatin

Carboplatin intravenous infusion
Eksperymentalny: Part D2 and I

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

Intravenous infusion of Rina-S

Inne nazwy:
  • PRO1184
  • GEN1184
  • Rinatabart sesutecan
Lek: Bevacizumab

Bevacizumab intravenous infusion
Eksperymentalny: Part D3, D4 and D5

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

Intravenous infusion of Rina-S

Inne nazwy:
  • PRO1184
  • GEN1184
  • Rinatabart sesutecan
Lek: Pembrolizumab

Pembrolizumab intravenous infusion
Eksperymentalny: Part L

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

Intravenous infusion of Rina-S

Inne nazwy:
  • PRO1184
  • GEN1184
  • Rinatabart sesutecan
Lek: Erythromycin

Erythromycin oral administration

Lek: Itraconazole

Itraconazole oral administration

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Części A, B i D - Występowanie zdarzeń niepożądanych z leczeniem (TEAES) [Bezpieczeństwo i tolerancja]
Ramy czasowe: Przez koniec leczenia, do około 1 rok.
Przez koniec leczenia, do około 1 rok.
Część K (tylko uczestnicy USA) - Liczba uczestników z klinicznie istotnymi zmianami w wynikach elektrokardiogramu (EKG) według Holtera
Ramy czasowe: Cykle od 1 do 3 (każdy cykl to 21 dni)
Cykle od 1 do 3 (każdy cykl to 21 dni)
Parts A, and D - Number of Participants with Dose Limiting Toxicity (DLT)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Parts A, B, D, and E -Time to Reach Cmax (Tmax) for Rina-S
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: At the end of Cycle 1 (each cycle is 21 days)
At the end of Cycle 1 (each cycle is 21 days)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Genmab

Śledczy

  • Dyrektor Studium: Study Official, Genmab

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

7 grudnia 2022

Zakończenie podstawowe (Szacowany)

1 grudnia 2028

Ukończenie studiów (Szacowany)

1 marca 2029

Daty rejestracji na studia

Pierwszy przesłany

4 października 2022

Pierwszy przesłany, który spełnia kryteria kontroli jakości

11 października 2022

Pierwszy wysłany (Rzeczywisty)

13 października 2022

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

4 listopada 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

2 listopada 2026

Ostatnia weryfikacja

1 października 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • GCT1184-01
  • PRO1184-001 (Inny identyfikator: Other Sponsor Identifier)
  • CTR20230813 (Identyfikator rejestru: Chinadrugtrials.org.cn)
  • jRCT2051250094 (Identyfikator rejestru: Japan Registry for Clinical Trials (jRCT))

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Tak

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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