En studie av Amivantamab subkutan (SC) administrasjon for behandling av avanserte solide maligniteter (PALOMA)
En åpen, multisenter, doseeskaleringsfase 1b-studie for å vurdere sikkerheten og farmakokinetikken ved subkutan tilførsel av Amivantamab, et humant bispesifikt EGFR- og cMet-antistoff for behandling av avanserte solide maligniteter
The purpose of this study is to assess the feasibility of subcutaneous (SC) administration of amivantamab based on safety and pharmacokinetics and determine a dose, dose regimen and formulation for amivantamab SC delivery.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
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Ontario
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Toronto, Ontario, Canada, M5G 2M9
- University Health Network
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California
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West Hollywood, California, Forente stater, 90048
- Cedars Sinai Medical Center
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Indiana
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Indianapolis, Indiana, Forente stater, 46256
- Community Health Network
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New York
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New York, New York, Forente stater, 10016
- Langone Health at NYC University, NYU School of Medicine
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Oregon
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Portland, Oregon, Forente stater, 97213
- Providence Portland Medical Center
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Tennessee
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Nashville, Tennessee, Forente stater, 37203
- Sarah Cannon Research Institute
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Manchester, Storbritannia, M20 4BX
- The Christie Nhs Foundation Trust
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Sutton, Storbritannia, SM2 5PT
- Royal Marsden Hospital
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Cheongju-si, Sør -Korea, 28644
- Chungbuk National University Hospital
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Seongnam-si, Sør -Korea, 13620
- Seoul National University Bundang Hospital
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Seoul, Sør -Korea, 03722
- Severance Hospital Yonsei University Health System
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Seoul, Sør -Korea, 06351
- Samsung Medical Center
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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:
- Part 1 and Part 2: Participant must have histologically or cytologically confirmed solid malignancy that is metastatic or unresectable and which may derive benefit from epidermal growth factor receptor (EGFR) or mesenchymal-epidermal transition tyrosine kinase receptor/hepatocyte growth factor receptor (cMet) directed therapy. Eligible tumor types include non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN), hepatocellular cancer (HCC), colorectal cancer (CRC), renal cell cancer (RCC), medullary thyroid cancer (MTC), gastroesophageal cancer (GEC), mesothelioma, breast cancer (BC) and ovarian cancer (OC). Participants must have either progressed after prior standard of care therapy for metastatic disease, be ineligible for, or have refused all other currently available therapeutic options. In cases where participants refuse currently available therapeutic options, this must be documented in the study records.
- Participant must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- A woman of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [beta-hCG]) at Screening and a negative urine or serum pregnancy test within 24 hours before the first dose of study drug
- A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 6 months after receiving the last dose of study drug
- A man who is sexually active with a woman of childbearing potential must agree to use a condom and his partner must also be practicing a highly effective method of contraception (that is, established use of oral, injected or implanted hormonal methods of contraception; placement of an Intrauterine device [IUD] or Intrauterine system [IUS])
Exclusion criteria:
- Participant has uncontrolled inter-current illness, including but not limited to poorly controlled hypertension or diabetes, ongoing or active systemic infection (that is, has discontinued all antibiotics for at least one week prior to first dose of study drug), diagnosed or suspected viral infection (except Human immunodeficiency virus [HIV] positive participants with 1 or more of the following: a) not receiving highly active antiretroviral therapy; b) a change in antiretroviral therapy within 6 months of the start of screening; c) cluster of differentiation 4 (CD4)+ T-cell count less than [<]350 per cubic millimeters [mm^3] at screening; d) an acquired immunodeficiency syndrome-defining opportunistic infection within 6 months of the start of screening), or psychiatric illness/social situation that would limit compliance with study requirements, including ability to self-care for anticipated toxicities [that is. rash or paronychia]. Participants with medical conditions requiring chronic continuous oxygen therapy are excluded
- Participant has had prior chemotherapy, targeted cancer therapy, or treatment with an investigational anti-cancer agent within 2 weeks or 4 half-lives, whichever is longer, before the first administration of study drug; or participant has received prior immunotherapy within 6 weeks before the first administration of study drug. For agents with long half-lives, the maximum required time since last dose is 4 weeks. Toxicities from previous anticancer therapies should have resolved to baseline levels or to Grade 1 or less, (except for alopecia [any grade], Grade less than or equal to [<=] 2 peripheral neuropathy, and Grade less than [<] 2 hypothyroidism stable on hormone replacement). Autoimmune toxicities from previous immunotherapy must be fully resolved to baseline levels
- Participants with untreated brain metastases. Participants with locally treated metastases that are clinically stable and asymptomatic for at least 2 weeks and who are off or receiving low-dose corticosteroid treatment (<=10 milligrams [mg] prednisone or equivalent) for at least 2 weeks prior to study treatment are eligible
- Participant has an active malignancy other than the disease under study requiring treatment
- Participant has leptomeningeal disease
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Part 1: Ami-LC-MD and Ami-LC
Participants in cohort 1a will receive amivantamab admixed with rHuPH20 (Ami-LC-MD) subcutaneous (SC) infusion and participants in cohort 1b will receive amivantamab (Ami-LC) SC infusion. |
Participants will receive amivantamab admixed with rHuPH20 SC infusion. Participants will receive amivantamab SC infusion. |
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Eksperimentell: Part 2: Ami-HC and Ami-HC-CF
Participants will receive SC infusion of newly developed high concentration amivantamab (Ami-HC) or SC injection of amivantamab co-formulated with rHuPH20 (Ami-HC-CF). |
Participants will receive amivantamab SC infusion. Participants will receive amivantamab co-formulated with rHuPH20 as SC injection. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Observed Amivantamab Serum Concentration Immediately Prior to the Next Dose Administration (Ctrough)
Tidsramme: Up to Day 29
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Ctrough is the observed amivantamab serum concentration immediately prior to the next drug administration. |
Up to Day 29
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Number of Participants with Adverse Event (AE)
Tidsramme: Up to 4 years 1 month
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An adverse event is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the drug. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. |
Up to 4 years 1 month
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Number of Participants with Dose Limiting Toxicity (DLT)
Tidsramme: Up to Day 28
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Number of participants with DLT will be assessed. |
Up to Day 28
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Number of Participants with Clinical Laboratory Abnormalities
Tidsramme: Up to 4 years 1 month
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Number of participants with clinical laboratory (hematology, clinical chemistry, and urinalysis) abnormalities will be assessed. |
Up to 4 years 1 month
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Number of Participants with Anti-amivantamab and Anti-rHuPH20 antibodies
Tidsramme: Up to 4 years 1 month
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Number of participants with anti-amivantamab and anti-rHuPH20 antibodies will be assessed. |
Up to 4 years 1 month
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Epidermal Growth Factor Receptor (EGFR) Concentrations
Tidsramme: Up to 4 years 1 month
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EGRF concentrations markers will be assessed. |
Up to 4 years 1 month
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Mesenchymal-Epidermal Transition Tyrosine Kinase Receptor/Hepatocyte Growth Factor Receptor (cMET) Markers
Tidsramme: Up to 4 years 1 month
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cMET markers will be analyzed. |
Up to 4 years 1 month
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Overall Response Rate (ORR)
Tidsramme: Up to 4 years 1 month
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ORR defined as the proportion of participants with partial response (PR) or better according to Response Criteria in Solid Tumors (RECIST) v1.1. |
Up to 4 years 1 month
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Part 2: Maximum Amivantamab Dosing Interval Between Time Zero to Steady State
Tidsramme: Up to 4 years 1 month
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Maximum amivantamab dosing interval Between time zero to steady state will be assessed. |
Up to 4 years 1 month
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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 (Faktiske)
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
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CR108891
- 2020-003225-36 (EudraCT-nummer)
- 61186372NSC1003 (Annen identifikator: Janssen Research & Development, LLC)
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 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
Legemiddel- og utstyrsinformasjon, studiedokumenter
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