NCT07636772Not yet recruitingPhase 2
A Phase II Study of AK146D1 Mono or Combined With AK112 in Advanced Urothelial Carcinoma
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
Source: ClinicalTrials.gov · Last updated 9 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 132 (estimated)
- First submitted
- 4 Jun 2026
- Start date
- Jun 2026
- Primary completion date
- Aug 2028
- Lead sponsor
- Akeso
- Diseases
- Bladder cancer
- NCT number
- NCT07636772
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 132
- From Jun 2026 to the primary completion date, Aug 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Other
- Currently participating in another interventional clinical study.
- Presence of active metastases to the central nervous system.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.