A Safety Study of the Pan-immunotherapy in Patients With Unresectable/Metastatic Solid Tumors or Lymphomas
27 augusti 2019 uppdaterad av: Han weidong, Chinese PLA General Hospital
A Phase I, Two-arm, Open-label, Single-center, Dose-escalation Study to Evaluate the Safety, Tolerability and Recommended Dose and Delivery Mode of the Pan-immunotherapy in Subjects With Unresectable/ Metastatic Solid Tumors or Lymphomas
Identification of T cell inhibitory signals, including PD-1/PD-L1, has prompted the development of a new class of cancer immunotherapy that could restore an adequate immunosurveillance against the neoplasm and enhance T-cell-mediated anticancer immune responses.
However, elimination of cancer by T cells is only one step in the Cancer-Immunity Cycle, which enable providing several therapeutic targets and tailoring of combinations of immune therapies.
Manganese has been confirmed to activate antigen-presenting cells and function as mucosal immunoadjuvants in pre-clinical studies.
This study is a first-in-man, Phase I, 3 + 3 dose escalation study of a combined regimen of Manganese and anti-PD-1 antibody with or without chemotherapies in subjects with unresectable/ metastatic solid tumors or lymphomas.
This study is designed to assess the safety, tolerability, pharmacokinetic profile (PK profile), mode of delivery and Recommended Phase 2 Dose (RP2D) of this regimen.
Studieöversikt
Status
Okänd
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Förväntat)
20
Fas
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
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Beijing
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Beijing, Beijing, Kina, 100853
- Rekrytering
- Biotherapeutic Department of Chinese PLA General Hospital
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Huvudutredare:
- Kaichao Feng, M.S
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Huvudutredare:
- Yan Zhang, M.S
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Huvudutredare:
- Meixia Chen, M.S
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Underutredare:
- Jiejie Liu, B.S
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Underutredare:
- Xiang Li, B.S
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Underutredare:
- Liang Dong, B.S
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 80 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Subjects must have histologically proven unresectable/ metastatic solid tumors or lymphomas.
- ≥ 18 years old.
- Life expectancy of at least 6 months.
- Eastern Cooperative Oncology Group performance status 0-2.
- Subjects must have at least one measurable lesion ≥ 1 cm as defined by response criteria.
- Subjects must have received at least two frontline therapies, except for patients initially diagnosed with local advanced or metastatic pancreatic cancer or cholangiocarcinoma.
- Subjects must be off prior therapy for at least 4 weeks prior to Day 1. Subjects with autologous hematopoietic stem-cell transplantation are eligible which must be more than 3 months. Subjects with Anti-PD-1 antibody are eligible which must be resistance.
- Adequate organ function.
- Participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study drug.
Exclusion Criteria:
- Subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications.
- Serious uncontrolled medical disorders or active infections, pulmonary infection especially.
- T cell lymphomas or leukemia.
- Prior organ allograft.
- Women who are pregnant or breastfeeding.
- Women with a positive pregnancy test on enrollment or prior to investigational product administration.
- Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: Dose-Escalation, intranasally
With a standard 3+3 dose escalation design, the enrollment will proceed until the maximum tolerated dose (MTD) has been defined or the highest dose level has been reached.
|
Administered intranasally in Arm 1 (0.05, 0.1 or 0.2 mg/kg/d) and by inhalation in Arm 2 (0.1, 0.2 or 0.4mg/kg/d) once daily in a 3-week cycle
Administered intravenously, at 2-4mg/kg on day 3 in a 3-week cycle
Andra namn:
Whether and which should be given depends on the treatment regimen before enrollment.
|
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Aktiv komparator: Dose-Escalation, inhalation
With a standard 3+3 dose escalation design, the enrollment will proceed until the MTD has been defined or the highest dose level has been reached.
|
Administered intranasally in Arm 1 (0.05, 0.1 or 0.2 mg/kg/d) and by inhalation in Arm 2 (0.1, 0.2 or 0.4mg/kg/d) once daily in a 3-week cycle
Administered intravenously, at 2-4mg/kg on day 3 in a 3-week cycle
Andra namn:
Whether and which should be given depends on the treatment regimen before enrollment.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Number of Subjects with treatment-related adverse events (AEs)
Tidsram: Approximately 6 months
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Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0.
AEs were considered to be treatment-related if they had started or worsened within the interval from first study drug administration until the follow-up visit.
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Approximately 6 months
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Number of subjects with specific Manganese-related adverse events
Tidsram: Approximately 6 months
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Manganese-related AEs were considered to be that start or worsen after administration Manganese administration，improve after withdrawal, and even occur again after re-administration.
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Approximately 6 months
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Preliminary efficacy evaluation
Tidsram: Approximately 6 months
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Objective response rate (ORR) and disease control rate (DCR) will be evaluated by investigators per the RECIST V1.1.
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Approximately 6 months
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The q3w pharmacokinetic profile of Manganese
Tidsram: Approximately 3 months
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PK parameters such as Maximum concentration (Cmax) are assessed.
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Approximately 3 months
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Number of participants with laboratory test abnormalities
Tidsram: Approximately 3 months
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The laboratory tests of serum cytokines and chemokines will be performed on day 1 and 3 of each cycle, and the abnormality will be determined by the investigator.
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Approximately 3 months
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 november 2018
Primärt slutförande (Förväntat)
31 december 2019
Avslutad studie (Förväntat)
31 maj 2020
Studieregistreringsdatum
Först inskickad
14 juni 2019
Först inskickad som uppfyllde QC-kriterierna
18 juni 2019
Första postat (Faktisk)
19 juni 2019
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
28 augusti 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
27 augusti 2019
Senast verifierad
1 augusti 2019
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Immunsystemets sjukdomar
- Neoplasmer efter histologisk typ
- Neoplasmer
- Lymfoproliferativa störningar
- Lymfatiska sjukdomar
- Immunproliferativa störningar
- Lymfom
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Antineoplastiska medel
- Immunologiska faktorer
- Spårelement
- Mikronäringsämnen
- Antikroppar
- Immunoglobuliner
- Immune Checkpoint-hämmare
- Mangan
Andra studie-ID-nummer
- CHN-PLAGH-BT-039
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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