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PRO1184 kehittyneille kiinteille kasvaimille (RAINFOL-01)

maanantai 2. marraskuuta 2026 päivittänyt: Genmab

Vaiheen 1/2 tutkimus PRO1184:stä potilailla, joilla on paikallisesti edenneitä ja/tai metastaattisia kiinteitä kasvaimia

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).

Tutkimuksen yleiskatsaus

Tila

Rekrytointi

Ehdot

Interventio / Hoito

Yksityiskohtainen kuvaus

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.

Opintotyyppi

Interventio

Ilmoittautuminen (Arvioitu)

952

Vaihe

  • Vaihe 2
  • Vaihe 1

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskeluyhteys

Opiskelupaikat

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

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

18 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)

Hyväksyy terveitä vapaaehtoisia

Ei

Sukupuolet, jotka voivat opiskella

Kaikki

Kuvaus

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.

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Hoito
  • Jako: Ei satunnaistettu
  • Inventiomalli: Peräkkäinen tehtävä
  • Naamiointi: Ei mitään (avoin tarra)

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: 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.
Lääke: Rina-S

Intravenous infusion of Rina-S

Muut nimet:
  • PRO1184
  • GEN1184
  • Rinatabart sesutecan
Kokeellinen: Part D1

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

Intravenous infusion of Rina-S

Muut nimet:
  • PRO1184
  • GEN1184
  • Rinatabart sesutecan
Lääke: Carboplatin

Carboplatin intravenous infusion
Kokeellinen: Part D2 and I

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

Intravenous infusion of Rina-S

Muut nimet:
  • PRO1184
  • GEN1184
  • Rinatabart sesutecan
Lääke: Bevacizumab

Bevacizumab intravenous infusion
Kokeellinen: Part D3, D4 and D5

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

Intravenous infusion of Rina-S

Muut nimet:
  • PRO1184
  • GEN1184
  • Rinatabart sesutecan
Lääke: Pembrolizumab

Pembrolizumab intravenous infusion
Kokeellinen: Part L

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

Intravenous infusion of Rina-S

Muut nimet:
  • PRO1184
  • GEN1184
  • Rinatabart sesutecan
Lääke: Erythromycin

Erythromycin oral administration

Lääke: Itraconazole

Itraconazole oral administration

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Osat A, B ja D - Hoitoon liittyvien haittavaikutusten esiintyvyys (TEAES) [Turvallisuus ja siedettävyys]
Aikaikkuna: Hoidon päättymisen kautta, noin vuosi.
Hoidon päättymisen kautta, noin vuosi.
Osa K (vain Yhdysvaltain osallistujat) - Osallistujien lukumäärä, joilla on kliinisesti merkittäviä muutoksia elektrokardiogrammissa (EKG) Holterilla
Aikaikkuna: Syklit 1 - 3 (jokainen sykli on 21 päivää)
Syklit 1 - 3 (jokainen sykli on 21 päivää)
Parts A, and D - Number of Participants with Dose Limiting Toxicity (DLT)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Parts A, B, D, and E -Time to Reach Cmax (Tmax) for Rina-S
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: At the end of Cycle 1 (each cycle is 21 days)
At the end of Cycle 1 (each cycle is 21 days)

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

Genmab

Tutkijat

  • Opintojohtaja: Study Official, Genmab

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus (Todellinen)

Keskiviikko 7. joulukuuta 2022

Ensisijainen valmistuminen (Arvioitu)

Perjantai 1. joulukuuta 2028

Opintojen valmistuminen (Arvioitu)

Torstai 1. maaliskuuta 2029

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Tiistai 4. lokakuuta 2022

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Tiistai 11. lokakuuta 2022

Ensimmäinen Lähetetty (Todellinen)

Torstai 13. lokakuuta 2022

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Keskiviikko 4. marraskuuta 2026

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Maanantai 2. marraskuuta 2026

Viimeksi vahvistettu

Torstai 1. lokakuuta 2026

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Avainsanat

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

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

Yksittäisten osallistujien tietojen suunnitelma (IPD)

Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?

EI

Lääke- ja laitetiedot, tutkimusasiakirjat

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