Clinical trial · Interventional
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
NCT07636772CI-TRIAL-00114053not yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Urothelial Carcinoma (UC) | Urothelial Carcinoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AK112 Injection | Drug | — | UNRESOLVED |
| AK146D1 for injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A
- description
- AK146D1 combined with AK112
- interventionNames
- Drug: AK146D1 for injection
- Drug: AK112 Injection
- type
- EXPERIMENTAL
- label
- Arm B
- description
- AK146D1 mono
- interventionNames
- Drug: AK146D1 for injection
Primary outcomes (3)
- measure
- Number of participants with dose limiting toxicities(DLTs)
- timeFrame
- During the first 3 weeks of treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.