A Phase II Study of AK146D1 Mono or Combined With AK112 in Advanced Urothelial Carcinoma
ConditionUrothelial Carcinoma (UC)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAkeso
About this trial
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.
Eligibility criteria
Qualifiers
Be able to understand and voluntarily sign the written informed consent form.
Age 18-75.
ECOG PS 0 or 1.
Expected lifespan ≥3 months.
Disqualifiers
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 .
Trial design
Treatments tested in this trial
- AK146D1 for injection
- AK112 Injection
Treatment groups
132 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov