A Phase II Study of AK146D1 Mono or Combined With AK112 in Advanced Urothelial Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AK146D1 for injection, AK112 Injection.
- Who it may be relevant to
- Registry conditions: Urothelial Carcinoma (UC). Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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
- Drug AK146D1 for injection
AK146D1 for injection is an antiTrop2/Nectin4 bispecific antibody-drug conjugate - Drug AK112 Injection
AK112 Injection is a PD-1/VEGF bispecific antibody
Primary outcome measures
- Number of participants with dose limiting toxicities(DLTs) [Time frame: During the first 3 weeks of treatment]
- Objective Response Rate(ORR) [Time frame: Up to 2 years]
- Number of participants with adverse events (AEs) [Time frame: From the time of informed consent signed through 90 days after the last dose]
Secondary outcome measures (5)
- Progression Free Survival(PFS) [Time frame: Up to 2 years]
- Disease Control Rate(DCR) [Time frame: Up to 2 years]
- Duration of response(DoR) [Time frame: Up to 2 years]
- Time to response(TTR) [Time frame: Up to 2 years]
- Overall survival(OS) [Time frame: Up to 2 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Fudan University Shanghai Cancer Center — Shanghai
Identifiers
NCT: NCT07636772 · AK146D1-203