A Phase II Study of AK146D1 Mono or Combined With AK112 in Advanced Urothelial Carcinoma
Starting soon · Phase 2
Conditions studied: Urothelial Carcinoma (UC)
In brief
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.
Key facts
- Study ID
- NCT07636772
- Run by
- Akeso
- People needed
- 132
- Starts
- 2026-06-22
- Expected to finish
- 2028-08-24
- Last updated by the study team
- 2026-06-09
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Fudan University Shanghai Cancer Center — Shanghai, China
Full record on ClinicalTrials.gov
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