Urothelial Carcinoma (UC)
Conditions
Brief summary
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.
Interventions
AK146D1 for injection is an antiTrop2/Nectin4 bispecific antibody-drug conjugate
DRUGAK112 Injection
AK112 Injection is a PD-1/VEGF bispecific antibody
Sponsors
Akeso
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with dose limiting toxicities(DLTs) | 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 |
| Objective Response Rate(ORR) | Up to 2 years | ORR is the proportion of participants with complete response(CR) or partial response(PR) |
| Number of participants with adverse events (AEs) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival(PFS) | 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. |
| Disease Control Rate(DCR) | Up to 2 years | DCR is defined as the proportion of participants with CR, PR, or SD |
| Duration of response(DoR) | 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. |
| Time to response(TTR) | Up to 2 years | TTR is defined as the time to objective response |
| Overall survival(OS) | Up to 2 years | OS is defined as the time from the first dose to death from any cause. |
Countries
China
Contacts
CONTACTTing Liu
Outcome results
None listed