A Clinical Study of Ivonescimab in Combination With Cadonilimab or Ipilimumab for Advanced Renal Cancer
SMT112-216
A Phase II Clinical Study of Ivonescimab in Combination With Cadonilimab or Ipilimumab in the Treatment of Advanced Renal Cancer
Sponsor study identifier
Secondary identifiers
OTHER · Akeso Biopharma
interventional
100
2 countries
2
Study Start
October 19, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
April 12, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 12, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
This study aims to evaluate the safety and efficacy of Ivonescimab alone or in combination with Cadonilimab or Ipilimumab in the treatment of advanced clear cell renal cell carcinoma (ccRCC).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 12, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 29, 2026
Actual (reported)October 16, 2026
Actual (reported)October 19, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
April 12, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 12, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Objective Response Rate (ORR)
ORR per RECIST v1.1 by investigator
From randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years.
Adverse Events (AEs)
Adverse events (AEs) as characterized by type, incidence, severity, seriousness, and relationship to study treatment
At the time of initiation of the first dose through 90 days after the last dose of study treatment.
Disease Control Rate (DCR)
From randomization to first occurrence of disease progression, death or study completion, whichever came first, assessed up to 3 years.
Duration of Response (DoR)
From time of first recorded response randomization to progressive disease, or death or study completion, whichever came first, assessed up to 3 years.
Progression Free Survival (PFS)
From randomization to progressive disease or death, whichever came first, assessed up to 3 years.
Overall Survival (OS)
From randomization to death, assessed up to 4 years.
Pharmacokinetics (PK)
From first dose of study drug until end of treatment, assessed up to 3 years.
Ivonescimab (dose level 1) + Cadonilimab
Ivonescimab (dose level 2) + Cadonilimab
Ivonescimab + Ipilimumab
Subjects will receive Ivonescimab (dose level 1) combined with Cadonilimab via intravenous infusion (IV) up to 2 years.
Ivonescimab (dose level 2) combined with Cadonilimab via intravenous infusion (IV) up to 2 years.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Ivonescimab (dose level 1) combined with Cadonilimab
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordGrouped treatment entry
Ivonescimab (dose level 2) combined with Cadonilimab
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordGrouped treatment entry
Ivonescimab combined with Ipilimumab
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordGrouped treatment entry
Nivolumab combined with Ipilimumab
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordClinical Study Site
Los Angeles, California, 90067, United States
Clinical Study Site
Beijing, Beijing Municipality, China
First Submitted
September 29, 2026
First Posted
October 16, 2026
Study Start
October 19, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
April 12, 2029
EstimatedPhase II Study of Platinum/Etoposide Plus Ivonescimab for Extensive-Stage Small Cell Lung Cancer
Pilot Study of Ivonescimab in Advanced/Metastatic Cutaneous Angiosarcoma
Ivonescimab
Nivolumab + Ipilimumab
Ivonescimab combined with Ipilimumab via intravenous infusion (IV) up to 4 cycles. Afterward, Ivonescimab for maintenance treatment up to 2 years total.
Ivonescimab monotherapy via intravenous infusion (IV) up to 2 years.
Nivolumab combined with Ipilimumab via intravenous infusion (IV) up to 4 cycles. Afterward, Nivolumab will be used for maintenance treatment up to 2 years total.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 12, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 16, 2026
Record last verified: 2026-10
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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