En studie av JNJ-95437446 hos deltagare med avancerade fasta tumörer
En fas 1-studie av JNJ-95437446 hos deltagare med avancerade fasta tumörer
The purpose of this study is to determine recommended phase 2 doses (RP2Ds) of JNJ-95437446 in Part 1, and to further evaluate the safety of the RP2Ds in participants with advanced solid tumors in Part 2.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 1
Kontakter och platser
Studiekontakt
- Namn: Study Contact
- Telefonnummer: 844-434-4210
- E-post: Participate-In-This-Study1@its.jnj.com
Studieorter
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Florida
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Sarasota, Florida, Förenta staterna, 34232
- Rekrytering
- Florida Cancer Specialists
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New York
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New York, New York, Förenta staterna, 10032
- Rekrytering
- Columbia University Medical Center Herbert Irving Pavilion
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Tennessee
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Nashville, Tennessee, Förenta staterna, 37203
- Rekrytering
- Tennessee Oncology
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Virginia
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Fairfax, Virginia, Förenta staterna, 22031
- Rekrytering
- NEXT Oncology
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Barcelona, Spanien, 8035
- Rekrytering
- Hosp Univ Vall D Hebron
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Madrid, Spanien, 28041
- Rekrytering
- Hosp. Univ. 12 de Octubre
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Madrid, Spanien, 28040
- Rekrytering
- Hosp Univ Fund Jimenez Diaz
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Madrid, Spanien, 28050
- Rekrytering
- Hosp Univ Hm Sanchinarro
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Seoul, Sydkorea, 06351
- Rekrytering
- Samsung Medical Center
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Seoul, Sydkorea, 03722
- Rekrytering
- Severance Hospital Yonsei University Health System
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Participants must have been previously diagnosed with histologically confirmed unresectable, locally advanced, or metastatic non-small cell lung cancer, colorectal carcinoma, or head and neck squamous cell carcinoma
- Participants with non-small cell lung cancer (NSCLC) adenocarcinoma and colorectal cancer (CRC) must have local molecular testing to determine epidermal growth factor receptor (EGFR) mutational status for NSCLC and Kirsten rat sarcoma/neuroblastoma ras viral oncogene/v-raf murine sarcoma oncogene B1 (KRAS/NRAS/BRAF) mutation status for CRC
- Have measurable or evaluable disease:
- Part 1: Either measurable or evaluable disease; Part 2: At least 1 measurable lesion per response evaluation criteria in solid tumors (RECIST) version (v) 1.1
- Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1 at screening
- Participants must have appropriate hematologic, renal, and hepatic function within the required limits
Exclusion Criteria:
- Any prior medical history of ILD/pneumonitis, including pneumonitis from anti-PD-1/ PD-L1 antibody or radiation that required systemic steroids
- Toxicity from prior anticancer therapy that has not resolved to Grade <=1
- Evidence of clinically significant active viral, bacterial, or fungal infection within 7 days before the first dose of study treatment requiring systemic or non-topical treatment
- History of clinically significant cardiovascular disease within 6 months prior to signing informed consent
- Participants with prior or concurrent second malignancy cannot be enrolled if prior/concurrent malignancy's natural history of treatment is likely to interfere with any safety or efficacy study endpoints
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Sekventiell tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: JNJ-95437446
Participants will receive JNJ-95437446 in Part 1 until at least two recommended phase 2 doses (RP2Ds) has been developed. In selected participants in Part 1, amivantamab may also be co-dosed with JNJ-95437446. Participants in Part 2 will receive JNJ-95437446 at the RP2Ds developed in Part 1. |
Amivantamab will be administered. JNJ-95437446 will be administered. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Number of Participants with Adverse Events (AEs) by Severity
Tidsram: Up to 2 years and 4 months
|
An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product and 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. |
Up to 2 years and 4 months
|
|
Part 1: Number of Participants with Dose-Limiting Toxicity (DLT)
Tidsram: Up to 21 days
|
The DLTs are specific adverse events that includes high grade hematologic or non-hematologic toxicities with exceptions and/or toxicities leading to treatment discontinuation. |
Up to 21 days
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Objective Response Rate
Tidsram: Up to 2 years and 4 months
|
Objective response rate (ORR) is defined as the percentage of participants who have best response of complete response (CR) or partial response (PR) according to response evaluation criteria in solid tumors (RECIST). |
Up to 2 years and 4 months
|
|
Duration of Response (DOR)
Tidsram: Up to 2 years and 4 months
|
DOR is defined for the responders from the date of initial documentation of a response to the date of first documented evidence of disease progression according to RECIST version (v.) 1.1, or death due to any cause, whichever occurs first. |
Up to 2 years and 4 months
|
|
Progression Free Survival (PFS)
Tidsram: Up to 2 years and 4 months
|
PFS is defined as the time from the first dose of JNJ-95437446 to either progressive disease (PD) or death due to any cause, whichever comes first. |
Up to 2 years and 4 months
|
|
Maximum Plasma Concentration (Cmax) for JNJ-95437446
Tidsram: Up to 2 years and 4 months
|
Serum samples will be analyzed to determine Cmax of JNJ-95437446 antibody-drug conjugate, total antibody, released payload and the payload's metabolite. |
Up to 2 years and 4 months
|
|
Time to Reach Cmax (Tmax) for JNJ-95437446
Tidsram: Up to 2 years and 4 months
|
Tmax defined as the the time to reach maximum observed plasma concentration of JNJ-95437446 antibody-drug conjugate, total antibody, released payload and the payload's metabolite will be reported. |
Up to 2 years and 4 months
|
|
Area Under the Plasma Concentration - Time (AUC [0-t]) Curve for JNJ-95437446 Antibody-Drug Conjugate, Total Antibody, Released Payload and the Payload's Metabolite
Tidsram: Up to 2 years and 4 months
|
AUC (0-t) defined as area under the plasma concentration-time curve during a dosing interval of JNJ-95437446 antibody-drug conjugate, total antibody, released payload and the payload's metabolite will be reported. |
Up to 2 years and 4 months
|
|
Number of Participants With Anti JNJ-95437446 Antibodies
Tidsram: Up to 2 years and 4 months
|
Serum samples will be analyzed for the detection of anti-JNJ-95437446 antibodies using a validated assay method. |
Up to 2 years and 4 months
|
Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 95437446LUC1001
- 2025-521535-36-00 (Registeridentifierare: EUCT number)
- 2025 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
The data sharing policy of Johnson & Johnson Innovative Medicine is available at 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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