Clinical Trial of DN022150 Combined With AG Chemotherapy as First-line Treatment for Locally Advanced or Metastatic Pancreatic Cancer With KRAS G12D Mutation
Studieoversigt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Undersøgelsestype
Undersøgelsestype
Tilmelding (Anslået)
Tilmelding
Fase
Fase
- Fase 2
- Fase 3
Kontakter og lokationer
Studiekontakt
Studiekontakt
- Navn: Man Xu
- Telefonnummer: +86 19979703650
- E-mail: xuman@kvvit.com
Deltagelseskriterier
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Voluntarily signed informed consent form
- Age 18-75 years (inclusive), male or female, at the time of signing informed consent
- Life expectancy ≥ 12 weeks
- Subjects with confirmed KRAS G12D who have not received prior systemic antineoplastic therapy for advanced or metastatic pancreatic cancer
- ECOG score of performance status 0 ~ 1
- At least one measurable lesion by RECIST v1.1 criteria
- Adequate organ function
- Effective methods of contraception during the study
Exclusion Criteria:
- Progression or other malignancy requiring treatment within 5 years prior to enrollment
- Prior targeted therapy for KRAS G12D
- With central nervous system metastasis
- Uncontrolled fluid accumulation
- Other anticancer therapy within 4 or 5 half-lives (whichever is shorter) before treatment
- Concomitant clinically significant cardiovascular disease
- Concurrent major acute or chronic infectious disease
- 4. Subjects who have undergone other major surgery other than diagnostic or biopsy, or are expected to undergo major surgery during the study;
- History of severe mental or psychological illness or drug abuse or a history of severe alcohol abuse
- Other situations not suitable for the study judged by the investigator
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Antal våben
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
Eksperimentel: DN022150+AG( Stage I )
Stage I,To evaluate the safety and tolerability of two different doses of DN022150 for Injection combined with AG regimen preset, and to determine the recommended dose of DN022150 for Injection combined with AG regimen for efficacy expansion based on the PK and preliminary efficacy data.
After the completion of efficacy expansion, the safety, tolerability, PK and preliminary efficacy data of the first phase will be synthesized to confirm the RP3D of DN022150 combined with AG regimen
|
28-day /cycle
Andre navne:
|
|
Eksperimentel: DN022150+AG( Stage II)
Stage II DN022150( RP3D)+AG
|
28-day /cycle
Andre navne:
|
|
Placebo komparator: DN022150 placebo+AG( Stage II)
Stage II DN022150 placebo+AG
|
28-day /cycle
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
DLT
Tidsramme: up to 2 years
|
stage I :To evaluate the safety and tolerability of different doses of DN022150 for Injection combined with AG regimen in participants with locally advanced or metastatic pancreatic cancer, including the incidence of dose limiting toxicity (DLT), explore the MTD, and determine the RP3D of DN022150 for Injection combined with AG regimen in combination with PK and efficacy data
|
up to 2 years
|
|
PFS as assessed by BICR per RECIST 1.1
Tidsramme: up to 2 years
|
stage II
|
up to 2 years
|
|
OS
Tidsramme: up to 2 years
|
stage II
|
up to 2 years
|
|
ORR
Tidsramme: up to 2 years
|
stage I
|
up to 2 years
|
Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence and severity of adverse events (AEs) graded by NCI-CTCAE v6.0
Tidsramme: up to 2 years
|
stage I&II
|
up to 2 years
|
|
DOR as assessed by the investigator per RECIST v1.1
Tidsramme: up to 2 years
|
stage I
|
up to 2 years
|
|
Cmin, ss
Tidsramme: up to 2 year
|
stage I&II: Steady State Trough Concentration
|
up to 2 year
|
|
Pancreatic cancer quality of life specific scale
Tidsramme: up to 2 years
|
stage II
|
up to 2 years
|
|
DCR as assessed by the investigator per RECIST v1.1
Tidsramme: up to 2 years
|
stage I
|
up to 2 years
|
|
PFS assessed by the investigator per RECIST v1.1
Tidsramme: up to 2 years
|
stage I
|
up to 2 years
|
|
OS
Tidsramme: up to 2 years
|
stage I
|
up to 2 years
|
|
PFS as assessed by the investigator per RECIST v1.1
Tidsramme: up to 2 years
|
stage II
|
up to 2 years
|
|
ORR as assessed by the investigator or BICR per RECIST v1.1
Tidsramme: up to 2 years
|
stage II
|
up to 2 years
|
|
DOR as assessed by the investigator or BICR per RECIST v1.1
Tidsramme: up to 2 years
|
stage II
|
up to 2 years
|
|
DCR as assessed by the investigator or BICR per RECIST v1.1
Tidsramme: up to 2 years
|
stage II
|
up to 2 years
|
|
Cmax,ss
Tidsramme: up to 2years
|
Maximum Steady-State Plasma Concentration
|
up to 2years
|
|
AUC0-t
Tidsramme: up to 2years
|
stage I&II AUC from time 0 to last measurable time
|
up to 2years
|
|
t1/2
Tidsramme: up to 2years
|
stageI&II Half-life
|
up to 2years
|
Samarbejdspartnere og efterforskere
Sponsor
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Studiestart
Primær færdiggørelse (Anslået)
Primær færdiggørelse
Studieafslutning (Anslået)
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Først opslået
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Sygdomme i det endokrine system
- Neoplasmer efter sted
- Neoplasmer
- Neoplasmer i fordøjelsessystemet
- Sygdomme i fordøjelsessystemet
- Neoplasmer i endokrine kirtler
- Pancreassygdomme
- Bugspytkirtel neoplasmer
- Undersøgelsesteknikker
- Epidemiologisk forskningsdesign
- Epidemiologiske metoder
- Forskningsdesign
- Metoder
- Kontrolgrupper
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- DN022150-301
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
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