Undersøgelse af DS-7300a hos deltagere med avancerede solide maligne tumorer
Fase I/II, todelt, multicenter første-i-menneske-undersøgelse af DS-7300a i forsøgspersoner med avancerede solide maligne tumorer
This is a single group study of participants with advanced solid tumors who have not been cured by other treatments. It is the first time the drug will be used in humans, and will be in two parts.
The primary purpose of the parts are:
- Dose Escalation Part: To evaluate the safety and tolerability and to determine the maximum tolerated dose and the recommended dose for expansion of ifinatamab deruxtecan (I-DXd).
- Dose Expansion Part: To investigate the safety, tolerability and antitumor activity of I-DXd when administered as a single agent.
This study is expected to last approximately 5 years from the time the first participant is enrolled to the time the last participant is off the study.
The number of treatment cycles is not fixed in this study. Participants who continue to benefit from the study treatment may continue, unless:
- they withdraw
- their disease gets worse
- they experience unacceptable side effects.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
- Fase 1
Kontakter og lokationer
Studiesteder
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Colorado
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Denver, Colorado, Forenede Stater, 80218
- Sarah Cannon Research Institute at HealthONE
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Florida
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Sarasota, Florida, Forenede Stater, 34232
- Florida Cancer Specialists
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02115
- Dana Farber Cancer Institute
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Michigan
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Detroit, Michigan, Forenede Stater, 48202
- Henry Ford Hospital
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Missouri
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St Louis, Missouri, Forenede Stater, 63110
- Washington University
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New Jersey
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Hackensack, New Jersey, Forenede Stater, 07601
- John Theurer Cancer Center at Hackensack University Medical Center
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New York
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New York, New York, Forenede Stater, 10065
- Memorial Sloan-Kettering Cancer Center
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Tennessee
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Nashville, Tennessee, Forenede Stater, 37203
- Tennessee Oncology
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Nashville, Tennessee, Forenede Stater, 37203
- SCRI Oncology Partners
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Texas
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Houston, Texas, Forenede Stater, 77030
- MDACC (MD Anderson Cancer Center)
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Aichi, Japan, 464-8681
- Aichi Cancer Center Hospital
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Chiba, Japan, 277-8577
- National Cancer Center Hospital East
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Hokkaido, Japan, 060-8648
- Hokkaido University Hospital
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Hyōgo, Japan, 650-0047
- Kobe City Medical Center General Hospital
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Kagawa, Japan, 761-0793
- Kagawa University Hospital
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Osaka, Japan, 565-0871
- The University of Osaka Hospital
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Saitama, Japan, 362-0806
- Saitama Cancer Center
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Shizuoka, Japan, 411-8777
- Shizuoka Cancer Center
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Tokyo, Japan, 104-0045
- National Cancer Center Hospital
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Tokyo, Japan, 160-8582
- Keio University Hospital
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Tokyo, Japan, 135-8550
- Cancer Institute Hospital of JFCR
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Tokyo, Japan, 142-8666
- Showa Medical University Hospital
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Ōsaka-sayama, Japan, 589-8511
- Kindai University Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
- Has at least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 on computed tomography (CT) or magnetic resonance imaging (MRI) as assessed by Investigator. Measurable lesions should not be from a previously irradiated site. If the lesion at a previously irradiated site is the only selectable target lesion, a radiological assessment showing significant progression of the irradiated lesion should be provided by the Investigator
- Has adequate cardiac, hematopoietic, renal and hepatic functions
- Has an adequate treatment washout period prior to start of study treatment
- Has a pathologically documented advanced/unresectable or metastatic head and neck squamous cell carcinoma, esophageal squamous cell carcinoma, squamous and adenocarcinoma non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), bladder cancer, sarcoma, endometrial cancer, melanoma, adenocarcinoma CRPC (primary neuroendocrine or histologically confirmed neuroendocrine differentiated prostate cancer is not allowed), breast cancer that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.
For Expansion Cohort 4 2L ESCC participants only:
- Has disease progression a post platinum-based and an immune checkpoint inhibitor (ICI) treatment per global or local guidelines, with a maximum of one prior line of systemic therapy for unresectable advanced or metastatic ESCC.
Exclusion Criteria:
- Has prior treatment with B7-H3 targeted agent, including I-DXd.
- Has had prior discontinuation of an antibody drug conjugate (ADC) that consists of an exatecan derivative (e.g., trastuzumab deruxtecan) due to treatment-related toxicities.
- Has multiple primary malignancies within 3 years, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, superficial GI tract tumors and non-muscle invasive bladder cancer curatively resected by endoscopic surgery.
- Uncontrolled significant cardiovascular disease
- Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder, or any autoimmune, connective tissue or inflammatory disorders with potential pulmonary involvement, prior pneumonectomy, or requirement for supplemental oxygen
- Has an uncontrolled infection requiring systemic therapy.
- Has substance abuse or any other medical conditions that would increase the safety risk to the subject or interfere with participation of the subject or evaluation of the clinical study in the opinion of the Investigator.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Sekventiel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Dose escalation
Participants with advanced solid tumors who received I-DXd IV Q3W monotherapy during dose escalation phase. Enrollment to this phase is currently closed. |
A total anti-B7H3 antibody and MAAA-1181a |
|
Eksperimentel: Dose expansion
Currently enrolling participants with advanced solid tumors who will receive I-DXd IV Q3W monotherapy at the recommended dose for expansion. |
A total anti-B7H3 antibody and MAAA-1181a |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Evaluer forekomsten af dosisbegrænsende toksiciteter (DLT'er)
Tidsramme: Dag 1 til dag 21 i cyklus 1 i dosiseskaleringsdelen
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Dag 1 til dag 21 i cyklus 1 i dosiseskaleringsdelen
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Evaluer forekomsten af bivirkninger (AE'er)
Tidsramme: Cyklus 1 Dag 1 gennem sygdomsprogression inden for 8 cyklusser (hver cyklus er 21 dage)
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Cyklus 1 Dag 1 gennem sygdomsprogression inden for 8 cyklusser (hver cyklus er 21 dage)
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Undersøg antitumoraktiviteten af ifinatamab deruxtecan (I-DXd)
Tidsramme: Cyklus 1 Dag 1 gennem sygdomsprogression inden for 8 cyklusser (hver cyklus er 21 dage)
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Cyklus 1 Dag 1 gennem sygdomsprogression inden for 8 cyklusser (hver cyklus er 21 dage)
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Karakteriser PK-parameteren AUClast
Tidsramme: Cyklus 1 Dag 1 gennem sygdomsprogression inden for 8 cyklusser (hver cyklus er 21 dage)
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Cyklus 1 Dag 1 gennem sygdomsprogression inden for 8 cyklusser (hver cyklus er 21 dage)
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Karakteriser PK-parameteren AUCtau
Tidsramme: Cyklus 1 Dag 1 gennem sygdomsprogression inden for 8 cyklusser (hver cyklus er 21 dage)
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Cyklus 1 Dag 1 gennem sygdomsprogression inden for 8 cyklusser (hver cyklus er 21 dage)
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Karakteriser PK-parameteren Cmax
Tidsramme: Cyklus 1 Dag 1 gennem sygdomsprogression inden for 8 cyklusser (hver cyklus er 21 dage)
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Cyklus 1 Dag 1 gennem sygdomsprogression inden for 8 cyklusser (hver cyklus er 21 dage)
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Karakteriser PK-parameteren Tmax
Tidsramme: Cyklus 1 Dag 1 gennem sygdomsprogression inden for 8 cyklusser (hver cyklus er 21 dage)
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Cyklus 1 Dag 1 gennem sygdomsprogression inden for 8 cyklusser (hver cyklus er 21 dage)
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Karakteriser PK-parameteren Ctrough
Tidsramme: Cyklus 1 Dag 1 gennem sygdomsprogression inden for 8 cyklusser (hver cyklus er 21 dage)
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Cyklus 1 Dag 1 gennem sygdomsprogression inden for 8 cyklusser (hver cyklus er 21 dage)
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Vurder forekomsten af anti-lægemiddel-antistoffer (ADA)
Tidsramme: Cyklus 1 Dag 1 gennem sygdomsprogression inden for 8 cyklusser (hver cyklus er 21 dage)
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Cyklus 1 Dag 1 gennem sygdomsprogression inden for 8 cyklusser (hver cyklus er 21 dage)
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Studieleder: Global Clinical Leader, Daiichi Sankyo
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- DS7300-A-J101
- 194992 (Anden identifikator: JapicCTI)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
De-identified individual participant data (IPD) on completed studies and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
IPD-delingstidsramme
Completed studies that has reached a global end or completion with all data set collected and analyzed, and for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
IPD-delingsadgangskriterier
Formal request from qualified scientific and medical researchers on IPD and clinical study documents on completed clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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