A Phase II Study of AK146D1 Mono or Combined With AK112 in Advanced Urothelial Carcinoma
4. juni 2026 opdateret af: Akeso
A Phase II Clinical Study to Evaluate the Safety，Tolerability，Pharmacokinetics and Anti-tumor Efficacy of AK146D1 Monotherapy or Combined With AK112 in Patients With Advanced Urothelial Carcinoma
This is a Phase II clinical study aimed at evaluating the safety, tolerability, antitumor efficacy, PK and immunogenicity of AK146D1 monotherapy or combined with AK112 in advanced Urothelial carcinoma.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
132
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Ting Liu
- Telefonnummer: +86 (0760) 8987 3999
- E-mail: clinicaltrials@akesobio.com
Studiesteder
-
-
-
Shanghai, Kina
- Fudan University Shanghai Cancer Center
-
Kontakt:
- Dingwei Ye
- Telefonnummer: 021-64175590
- E-mail: dwyeli@163.com
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- Be able to understand and voluntarily sign the written informed consent form.
- Age 18-75.
- ECOG PS 0 or 1.
- Expected lifespan ≥3 months.
- Histologically or cytologically documented Urothelial carcinoma.
- At least one measurable lesion according to RECIST v1.1.
- Sufficient organ function.
Exclusion Criteria:
- Having other active malignancies within 3 years.
- Currently participating in another interventional clinical study.
- Presence of active metastases to the central nervous system.
- Prior chemotherapy agent targeting topoisomerase I .
- Receipt of systemic anti-tumor therapy within 4 weeks prior to the first dose.
- Patients with clinically significant cardiovascular or cerebrovascular diseases or risks.
- Patients with active autoimmune diseases requiring systemic treatment within 2 years.
- Receipt of systemic anti-infective therapy within 2 weeks prior to the first dose.
- Previous history of severe hypersensitivity reactions.
- Patients with a history of mental illness and incapacitated or limited capacity.
- Any disease or condition that, in the opinion of the investigator, would compromise patient safety or interfere with study assessments.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Arm A
AK146D1 combined with AK112
|
AK146D1 for injection is an antiTrop2/Nectin4 bispecific antibody-drug conjugate
AK112 Injection is a PD-1/VEGF bispecific antibody
|
|
Eksperimentel: Arm B
AK146D1 mono
|
AK146D1 for injection is an antiTrop2/Nectin4 bispecific antibody-drug conjugate
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of participants with dose limiting toxicities(DLTs)
Tidsramme: During the first 3 weeks of treatment
|
DLTs are defined as toxicities that meet predefined severity criteria, and assessed as having a suspected relationship to study drug
|
During the first 3 weeks of treatment
|
|
Objective Response Rate(ORR)
Tidsramme: Up to 2 years
|
ORR is the proportion of participants with complete response(CR) or partial response(PR)
|
Up to 2 years
|
|
Number of participants with adverse events (AEs)
Tidsramme: From the time of informed consent signed through 90 days after the last dose
|
AEs refer to any untoward medical occurrence or deterioration of existing medical events after the participants sign the ICFs, whether or not considered related to the study treatment.
|
From the time of informed consent signed through 90 days after the last dose
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Progression Free Survival(PFS)
Tidsramme: Up to 2 years
|
PFS is defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause,whichever occurs first.
|
Up to 2 years
|
|
Disease Control Rate(DCR)
Tidsramme: Up to 2 years
|
DCR is defined as the proportion of participants with CR, PR, or SD
|
Up to 2 years
|
|
Duration of response(DoR)
Tidsramme: Up to 2 years
|
DoR is defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first.
|
Up to 2 years
|
|
Time to response(TTR)
Tidsramme: Up to 2 years
|
TTR is defined as the time to objective response
|
Up to 2 years
|
|
Overall survival(OS)
Tidsramme: Up to 2 years
|
OS is defined as the time from the first dose to death from any cause.
|
Up to 2 years
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
22. juni 2026
Primær færdiggørelse (Anslået)
24. august 2028
Studieafslutning (Anslået)
24. august 2028
Datoer for studieregistrering
Først indsendt
4. juni 2026
Først indsendt, der opfyldte QC-kriterier
4. juni 2026
Først opslået (Faktiske)
9. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
9. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. juni 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- AK146D1-203
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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