Uno studio su JNJ-89402638 per il cancro del colon-retto metastatico
Uno studio di fase I su JNJ-89402638 per il cancro del colon-retto metastatico non resecabile
The purpose of this study is to determine the putative recommended phase 2 dose(s) (RP2Ds) and best way to take (optimal route of administration) JNJ-89402638 and to determine the safety of JNJ-89402638 at the RP2D(s) in participants with metastatic colorectal cancer (mCRC) and metastatic gastric cancer (mGAC) and to determine the safety and tolerability of JNJ-89402638 in combination with bevacizumab or biosimilar with or without chemotherapy in participants with mCRC.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 1
Contatti e Sedi
Contatto studio
- Nome: Study Contact
- Numero di telefono: 844-434-4210
- Email: Participate-In-This-Study1@its.jnj.com
Luoghi di studio
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Seoul, Corea del Sud, 05505
- Reclutamento
- Asan Medical Center
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Seoul, Corea del Sud, 03722
- Reclutamento
- Severance Hospital Yonsei University Health System
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Barcelona, Spagna, 08035
- Reclutamento
- Hosp Univ Vall D Hebron
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Madrid, Spagna, 28041
- Reclutamento
- Hosp. Univ. 12 de Octubre
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Madrid, Spagna, 28040
- Reclutamento
- Hosp Univ Fund Jimenez Diaz
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Madrid, Spagna, 28050
- Reclutamento
- Hosp Univ Hm Sanchinarro
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Arizona
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Tucson, Arizona, Stati Uniti, 85719
- Reclutamento
- University of Arizona Cancer Center
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Colorado
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Aurora, Colorado, Stati Uniti, 80045
- Reclutamento
- University of Colorado Denver Anschultz Medical Campus
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Florida
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Sarasota, Florida, Stati Uniti, 34232
- Reclutamento
- Florida Cancer Specialists
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Indiana
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Indianapolis, Indiana, Stati Uniti, 46256
- Reclutamento
- Community Health Network
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Michigan
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Grand Rapids, Michigan, Stati Uniti, 49546
- Reclutamento
- Start Midwest
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Washington
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Seattle, Washington, Stati Uniti, 98104
- Reclutamento
- Swedish Cancer Institute
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
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For Part 1 (dose escalation), Part 2 (Arm A [JNJ-89402638 monotherapy]): Have histologically or cytologically confirmed diagnosis of colorectal adenocarcinoma (CRC) progressing after 2 or more prior lines of standard therapy in the metastatic/unresectable setting; For Part 2 Arm B (JNJ-89402638 + bevacizumab or biosimilar): Have histologically or cytologically confirmed diagnosis of CRC progressing after 2 or more prior lines of standard therapy in the metastatic/unresectable setting; For Part 2 Arm C (JNJ-89402638 + FOLFOX/bevacizumab or biosimilar): Have histologically or cytologically confirmed diagnosis of microsatellite stable (MSS) or proficient mismatch repair (pMMR) CRC progressing after 1 or more prior lines of standard therapy in the metastatic/unresectable setting. Participants must have previously received a fluoropyrimidine and irinotecan doublet (such as FOLFIRI); For Part 2 Arm D (JNJ-89402638 + FOLFIRI/bevacizumab or biosimilar): Have histologically or cytologically confirmed diagnosis of MSS or pMMR CRC progressing after 1 prior line of standard therapy in the metastatic/unresectable setting. Must not have received irinotecan previously for metastatic disease; For Part 2 Arm E (JNJ-89402638 monotherapy in mGAC): Have histologically or cytologically confirmed diagnosis of gastric adenocarcinoma or gastroesophageal junction adenocarcinoma progressing after 1 or more prior lines of standard therapy in the metastatic/unresectable setting
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Have evaluable or measurable disease per response evaluation criteria in solid tumors (RECIST) version 1.1
- Part 1: Must have either measurable or evaluable disease
- Part 2: Must have at least 1 measurable lesion
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Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
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Have an estimated or measured glomerular filtration rate (GFR) greater than or equal to (>=) 30 milliliter per minute (mL/min) based on modification of diet in renal disease (MDRD) 4-variable formula
Exclusion Criteria:
- Active (new or progressive) brain metastases, leptomeningeal disease, or untreated spinal cord compression
- Toxicity from prior anticancer therapy that has not resolved to Grade less than or equal to (<=)1 (except alopecia, vitiligo, Grade <= 2 peripheral neuropathy, or endocrinopathies that are stable on hormone replacement). For Part 2 Arm C: Grade 2 or higher peripheral neuropathy is considered exclusionary
- Has a prior or concurrent second malignancy (other than the disease under study) unless natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment
- Received glucocorticoids (doses >10 mg/day prednisone or equivalent) within 7 days prior to the first dose of study drug
- Received or plans to receive any live, attenuated vaccine within 4 weeks before the first dose of study treatment or within 4 weeks after the last dose of study treatment
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione sequenziale
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Part 1 (Dose Expansion)
Participants with unresectable metastatic colorectal adenocarcinoma (mCRC) will receive JNJ-89402638 in Part 1 (Dose escalation) of the study and the dose levels will be escalated sequentially until the recommended Phase 2 Dose(s) (RP2D) and optimal route(s) of administration for JNJ-89402638 monotherapy have been identified. |
JNJ-89402638 will be administered. |
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Sperimentale: Part 2 (Dose Expansion): Arm A
Participants with mCRC will receive JNJ-89402638 at the RP2D(s) and route as determined in Part 1 as a monotherapy. |
JNJ-89402638 will be administered. |
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Sperimentale: Part 2 (Dose Expansion): Arm B
Participants with mCRC will receive JNJ-89402638 at the RP2D(s) determined in Part 1 along with bevacizumab or biosimilar. |
JNJ-89402638 will be administered. Bevacizumab or biosimilar will be administered. |
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Sperimentale: Part 2 (Dose Expansion): Arm C
Participants with mCRC will receive JNJ-89402638 at the RP2D(s) determined in Part 1 along with bevacizumab or biosimilar and FOLFOX. |
JNJ-89402638 will be administered. Bevacizumab or biosimilar will be administered. Chemotherapy agent FOLFOX will be administered. |
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Sperimentale: Part 2 (Dose Expansion): Arm D
Participants with mCRC will receive JNJ-89402638 at the RP2D(s) determined in Part 1 in combination with bevacizumab or biosimilar and FOLFIRI. |
JNJ-89402638 will be administered. Bevacizumab or biosimilar will be administered. Chemotherapy agent FOLFIRI will be administered. |
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Sperimentale: Part 2 (Dose Expansion): Arm E
Participants with metastatic gastric adenocarcinoma (mGAC) will receive JNJ-89402638 at the RP2D(s) and route as determined in Part 1. |
JNJ-89402638 will be administered. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Part 1 and Part 2: Number of Participants with Adverse Events (AEs) by Severity
Lasso di tempo: From Baseline up to approximately 24 months
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An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Severity of AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) will be graded per American Society for Transplantation and Cellular Therapy (ASTCT) consensus. |
From Baseline up to approximately 24 months
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Part 1: Number of Participants with Dose-Limiting Toxicity (DLT)
Lasso di tempo: From Baseline up to 28 days
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The DLTs are specific adverse events including high grade hematologic or non-hematologic toxicities. |
From Baseline up to 28 days
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Part 1 and Part 2: Serum Concentration for JNJ-89402638
Lasso di tempo: Up to approximately 24 months
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Serum Concentration for JNJ-89402638 will be reported. |
Up to approximately 24 months
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Part 1 and Part 2: Maximum Serum Concentration (Cmax) of JNJ-89402638
Lasso di tempo: Up to approximately 24 months
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Cmax of JNJ-89402638 will be reported. |
Up to approximately 24 months
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Part 1 and Part 2: Minimum Serum Concentration (Cmin) of JNJ-89402638
Lasso di tempo: Up to approximately 24 months
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Cmin of JNJ-89402638 will be reported. |
Up to approximately 24 months
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Part 1 and Part 2: Time to Reach Maximum Observed Serum Concentration (Tmax) of JNJ-89402638
Lasso di tempo: Up to approximately 24 months
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Tmax of JNJ-89402638 will be reported. |
Up to approximately 24 months
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Part 1 and Part 2: Area Under the Serum Concentration-time Curve (AUC) of JNJ-89402638
Lasso di tempo: Up to approximately 24 months
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AUC of JNJ-89402638 will be reported. |
Up to approximately 24 months
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Part 1 and Part 2: Number of Participants with Presence of Anti-JNJ-89402638 Antibodies
Lasso di tempo: Up to approximately 24 months
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Participants with anti-JNJ-89402638 antibodies will be reported. |
Up to approximately 24 months
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Part 1 and Part 2: Overall Response (OR)
Lasso di tempo: Up to approximately 24 months
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Overall response is best response of complete response (CR) or partial response (PR), assessed according to response evaluation criteria in solid tumors (RECIST) version 1.1. |
Up to approximately 24 months
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Part 1 and Part 2: Complete Response (CR)
Lasso di tempo: Up to approximately 24 months
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Complete response is defined as a best response of CR assessed according to RECIST version 1.1. |
Up to approximately 24 months
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Part 1 and Part 2: Time to Response (TTR)
Lasso di tempo: Up to approximately 24 months
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TTR is defined for participants who achieved an OR from the time of the first dose of study treatment to the first response of PR or better as assessed according to RECIST version 1.1. |
Up to approximately 24 months
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Part 1 and Part 2: Duration of Response (DOR)
Lasso di tempo: Up to approximately 24 months
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DOR is defined for participants who achieved an OR in the time between the date of initial documentation of first response of PR or better to the date of first documented evidence of progressive disease or death due to any cause, whichever occurs first, as assessed according to RECIST version 1.1 |
Up to approximately 24 months
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Collaboratori e investigatori
Investigatori
- Direttore dello studio: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Neoplasie per sede
- Neoplasie
- Malattie intestinali
- Neoplasie dell'apparato digerente
- Malattie dell'apparato digerente
- Malattie gastrointestinali
- Neoplasie intestinali
- Malattie del retto
- Malattie del colon
- Neoplasie colorettali
- Neoplasie gastrointestinali
- Aminoacidi, peptidi e proteine
- Proteine
- Anticorpi, monoclonali, umanizzati
- Anticorpi, monoclonali
- Anticorpi
- Immunoglobuline
- Immunoproteine
- Proteine del sangue
- Globuline sieriche
- Globuline
- Bevacizumab
- Protocollo Folfox
- Protocollo IFL
Altri numeri di identificazione dello studio
- 89402638GIC1001
- 2024-516526-66-00 (Identificatore di registro: EUCT number)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.
Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .