A Phase II Study of AK146D1 Combined With AK112 in Advanced Breast Cancer
ConditionAdvanced Breast Cancer
Trial statusRecruiting
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 combined with AK112 in advanced breast cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Be able to understand and voluntarily sign the written informed consent form.
Aged of ≥ 18 years and ≤75 years.
ECOG PS 0 or 1.
The expected lifespan is ≥3 months.
Disqualifiers
Patients had breast cancer amenable to curative treatment at study enrollment.
Concurrent other histopathological types confirmed by tumor histology or cytology.
Having other active malignancies within 3 years.
Currently participating in another interventional clinical study.
Trial design
Design model
Sequential
Treatments tested in this trial
AK146D1 for injection
DrugAK146D1 for injection is an anti-Trop2/Nectin4 bispecific antibody-drug conjugate.
AK112 Injection
DrugAK112 Injection is a PD-1/VEGF bispecific antibody.
Treatment groups
200 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 pre-defined severity criteria, and assessed as having a suspected relationship to study drug.
Time frame
During the first 3 weeks of treatment in Safety Run-in Phase.2
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 signing informed consent form through 30 days(for AEs) or 90 days(for SAEs) after the last dose of study drug.3
Objective Response Rate (ORR) assessed by investigator per RECIST v1.1
ORR is the proportion of participants with complete response(CR) or partial response(PR) , assessed based on RECIST v1.1.
Time frame
Up to approximately 2 years.Secondary outcomes
1
Progression Free Survival (PFS) assessed by investigator per RECIST v1.1
PFS is defined as the time from the start of treatment until the first documentation of disease progression (based on RECIST Version 1.1) or death due to any cause, whichever occurs first.
Time frame
Up to approximately 2 years.2
Disease Control Rate (DCR) assessed per RECIST v1.1
DCR is defined as the proportion of participants with CR, PR, or SD, assessed based on RECIST v1.1.
Time frame
Up to approximately 2 years.3
Duration of response (DoR) assessed by the investigator per RECIST v1.1
DoR is defined as the duration from the first documentation of objective response to the first documented disease progression (based on RECIST Version 1.1) or death due to any cause, whichever occurs first.
Time frame
Up to approximately 2 years.4
Time to response (TTR) assessed by the investigator per RECIST v1.1
TTR is defined as the time to objective response based on RECIST v1.1.
Time frame
Up to approximately 2 years. Source ClinicalTrials.gov