En studie av JNJ-89402638 for metastatisk tykktarmskreft
En fase I-studie av JNJ-89402638 for ikke-opererbar metastatisk tykktarmskreft
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.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Fase 1
Kontakter og plasseringer
Studiekontakt
- Navn: Study Contact
- Telefonnummer: 844-434-4210
- E-post: Participate-In-This-Study1@its.jnj.com
Studiesteder
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Arizona
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Tucson, Arizona, Forente stater, 85719
- Rekruttering
- University of Arizona Cancer Center
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Colorado
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Aurora, Colorado, Forente stater, 80045
- Rekruttering
- University of Colorado Denver Anschultz Medical Campus
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Florida
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Sarasota, Florida, Forente stater, 34232
- Rekruttering
- Florida Cancer Specialists
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Indiana
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Indianapolis, Indiana, Forente stater, 46256
- Rekruttering
- Community Health Network
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Michigan
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Grand Rapids, Michigan, Forente stater, 49546
- Rekruttering
- Start Midwest
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Washington
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Seattle, Washington, Forente stater, 98104
- Rekruttering
- Swedish Cancer Institute
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Barcelona, Spania, 08035
- Rekruttering
- Hosp Univ Vall D Hebron
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Madrid, Spania, 28041
- Rekruttering
- Hosp. Univ. 12 de Octubre
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Madrid, Spania, 28040
- Rekruttering
- Hosp Univ Fund Jimenez Diaz
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Madrid, Spania, 28050
- Rekruttering
- Hosp Univ Hm Sanchinarro
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Seoul, Sør -Korea, 05505
- Rekruttering
- Asan Medical Center
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Seoul, Sør -Korea, 03722
- Rekruttering
- Severance Hospital Yonsei University Health System
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Sekvensiell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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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Eksperimentell: 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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Eksperimentell: 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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Eksperimentell: 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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Eksperimentell: 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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Eksperimentell: 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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Part 1 and Part 2: Number of Participants with Adverse Events (AEs) by Severity
Tidsramme: 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)
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Part 1 and Part 2: Serum Concentration for JNJ-89402638
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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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Samarbeidspartnere og etterforskere
Etterforskere
- Studieleder: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Neoplasmer etter nettsted
- Neoplasmer
- Tarmsykdommer
- Neoplasmer i fordøyelsessystemet
- Sykdommer i fordøyelsessystemet
- Gastrointestinale sykdommer
- Intestinale neoplasmer
- Rektale sykdommer
- Kolonsykdommer
- Kolorektale neoplasmer
- Gastrointestinale neoplasmer
- Aminosyrer, peptider og proteiner
- Proteiner
- Antistoffer, monoklonalt, humanisert
- Antistoffer, monoklonalt
- Antistoffer
- Immunoglobuliner
- Immunoproteiner
- Blodproteiner
- Serumglobuliner
- Globuliner
- Bevacizumab
- FOLFOX -protokoll
- IFL -protokoll
Andre studie-ID-numre
- 89402638GIC1001
- 2024-516526-66-00 (Registeridentifikator: EUCT number)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
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.
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