A Phase II Study of AK146D1 Mono or Combined With AK112 in Advanced Urothelial Carcinoma
ConditionUrothelial Carcinoma (UC)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAkeso
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Be able to understand and voluntarily sign the written informed consent form.
Age 18-75.
ECOG PS 0 or 1.
Expected lifespan ≥3 months.
Disqualifiers
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 .
Trial design
Design model
Parallel
Treatments tested in this trial
AK146D1 for injection
DrugAK146D1 for injection is an antiTrop2/Nectin4 bispecific antibody-drug conjugate
AK112 Injection
DrugAK112 Injection is a PD-1/VEGF bispecific antibody
Treatment groups
132 Participants
are divided into 2 treatment groupsGroup A: Arm AExperimental treatment 2 interventions
Group B: Arm BExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants with dose limiting toxicities(DLTs)
DLTs are defined as toxicities that meet predefined severity criteria, and assessed as having a suspected relationship to study drug
Time frame
During the first 3 weeks of treatment2
Objective Response Rate(ORR)
ORR is the proportion of participants with complete response(CR) or partial response(PR)
Time frame
Up to 2 years3
Number of participants with adverse events (AEs)
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.
Time frame
From the time of informed consent signed through 90 days after the last doseSecondary outcomes
1
Progression Free Survival(PFS)
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.
Time frame
Up to 2 years2
Disease Control Rate(DCR)
DCR is defined as the proportion of participants with CR, PR, or SD
Time frame
Up to 2 years3
Duration of response(DoR)
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.
Time frame
Up to 2 years4
Time to response(TTR)
TTR is defined as the time to objective response
Time frame
Up to 2 years Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: