AK146D1 alone or with AK112 for advanced urothelial cancer
Tests AK146D1, alone or with AK112, in adults with advanced urothelial carcinoma.
Plain-language title generated from the registry record
Registry title: A Phase II Study of AK146D1 Mono or Combined With AK112 in Advanced Urothelial Carcinoma
Key facts
- Where
- Shanghai, ChinaSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07636772, who can take part
Where in China
- Fudan University Shanghai Cancer CenterShanghai, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Akeso
- Trial code
- NCT07636772
- Record updated
- 9 June 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: Prior chemotherapy agent targeting topoisomerase I ; Receipt of systemic anti-tumor therapy within 4 weeks prior to the first dose; Receipt of systemic anti-infective therapy within 2 weeks prior to the first dose; Previous history of severe hypersensitivity reactions; Having other active malignancies within 3 years; Patients with clinically significant cardiovascular or cerebrovascular diseases or risks; Patients with active autoimmune diseases requiring systemic treatment within 2 years; 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; Currently participating in another interventional clinical study; Presence of active metastases to the central nervous system.