A Phase II Study of AK146D1 Mono or Combined With AK112 in Advanced Urothelial Carcinoma (NCT07636772) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Phase II Study of AK146D1 Mono or Combined With AK112 in Advanced Urothelial Carcinoma
China132 participantsStarted 2026-06-22
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with dose limiting toxicities(DLTs)
Timeframe: During the first 3 weeks of treatment
2
Objective Response Rate(ORR)
Timeframe: Up to 2 years
3
Number of participants with adverse events (AEs)
Timeframe: From the time of informed consent signed through 90 days after the last dose