Sponsor:
Johnson & Johnson Enterprise Innovation Inc.
Collaborator:
-
Studienleiter
Johnson & Johnson Enterprise Innovation, Inc Clinical Trial Study Director Johnson & Johnson Enterprise Innovation Inc.
Kontakt
Study Contact Kontakt: Phone: 844-434-4210 E-Mail: Participate-In-This-Study@its.jnj.com» Kontaktdaten anzeigen
Studienlocations (3 von 9)
Charite Research Organisation GmbH 12203 Berlin (Berlin) GermanyRekrutierend» Google-MapsUniversitaetsklinikum Giessen und Marburg GmbH 35392 Giessen (Hessen) GermanyRekrutierend» Google-MapsRoswell Park Comprehensive Cancer Center 14203 Buffalo United StatesRekrutierend» Google-Maps
Herbert Irving Comprehensive Cancer Center, Columbia University Medical Center 10032 New York United StatesRekrutierend» Google-MapsNext Virginia 22031 Fairfax United StatesRekrutierend» Google-MapsSeverance Hospital Yonsei University Health System 03722 Seoul Korea, Republic ofRekrutierend» Google-MapsSamsung Medical Center 06351 Seoul Korea, Republic ofRekrutierend» Google-MapsHosp. Univ. Quiron Dexeus 08028 Barcelona SpainRekrutierend» Google-MapsHosp. Univ. Vall D Hebron 8035 Barcelona SpainRekrutierend» Google-Maps
1. Number of Participants with Adverse Events (AEs) by Severity (Time Frame - Up to 2 years 5 months): An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for adverse events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.
2. Number of Participants with Dose Limiting Toxicities (DLTs) (Time Frame - Up to 2 years 5 months): The DLTs are specific adverse events and are defined as any of the following: non-hematologic toxicity and hematological toxicity.
Secondary outcome:
1. Maximum Observed Plasma Concentration (Cmax) of JNJ-86974680 (Time Frame - Up to 2 years 5 months): Cmax is defined as maximum observed plasma concentration of JNJ-86974680.
2. Minimum Concentration (Cmin) of JNJ-86974680 (Time Frame - Up to 2 years 5 months): Cmin is defined as the minimum observed plasma concentration of JNJ-86974680.
3. Time to Reach the Maximum Observed Plasma Concentration (Tmax) of JNJ-86974680 (Time Frame - Up to 2 years 5 months): Tmax is defined the time to reach the maximum observed plasma concentration of JNJ-86974680.
4. Terminal Elimination Half-life (t1/2) of JNJ-86974680 (Time Frame - Up to 2 years 5 months): T1/2 is defined as terminal elimination half-life of JNJ-86974680.
5. Area Under the Plasma Concentration-time Curve From Time Zero to Time t (AUC0-t) of JNJ-86974680 (Time Frame - Up to 2 years 5 months): (AUC0-t) is defined as area under the plasma concentration of JNJ-86974680 versus time curve from the time of dose administration to time of last quantifiable concentration (0-t).
6. Area Under the Plasma Concentration-time Curve of JNJ-8697468 over the Dosing Interval (tau) (Time Frame - Up to 2 years 5 months): AUCtau is defined as the area under the plasma concentration-time curve of JNJ-8697468 over the dosing interval (tau).
7. Apparent Clearance (CL/F) of JNJ-86974680 (Time Frame - Up to 2 years 5 months): Apparent clearance of JNJ-86974680 was defined as a measure of the rate at which a drug got metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.
8. Apparent Volume of Distribution (V/F) of JNJ-86974680 (Time Frame - Up to 2 years 5 months): V/F was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of JNJ-86974680.
9. Part 2: Overall Response Rate (ORR) (Time Frame - Up to 2 years 5 months): ORR is defined as the percentage of participants who have a best response of complete response (CR) or partial response (PR) according to response evaluation criteria in solid tumors (RECIST) version (v)1.1, maintained for at least 4 weeks.
10. Part 2: Complete Response Rate (CRR) (Time Frame - Up to 2 years 5 months): CRR is defined as the proportion of participants with a best response of CR.
11. Part 2: Duration of Response (DOR) (Time Frame - Up to 2 years 5 months): DoR is defined as the time from the date of first initial documentation of a response to the date of first documented evidence of progression of disease according to immunotherapy response evaluation criteria in solid tumors (iRECIST) or death due to any cause, whichever occurs first.
12. Part 2: Disease Control Rate (DCR) (Time Frame - Up to 2 years 5 months): DCR is defined as the percentage of participants who achieve a best of response of PR, CR, or stable disease using RECIST v1.1.
Experimental: Part 1: JNJ-86974680+Cetrelimab Participants will receive JNJ-86974680 alone (dose 1, dose 2, dose 3, and dose 4) daily in 4 cohorts and then along with a set dose of cetrelimab.
Experimental: Part 2: JNJ-86974680+Cetrelimab+Radiation Therapy (RT) Participants will receive treatment with the identified safe dose of JNJ-86974680 in combination with cetrelimab from part 1, in conjunction with radiation.