Akeso trial for cadonilimab in kidney cancer completes with enrollment cut 60% to 28
NCT05256472 finished with 28 patients, well below the 70 the sponsor had targeted, and no primary ORR data have been posted to reveal whether the shrunken cohort still answers the question.
Executive Summary
- Akeso's Phase 2 trial of cadonilimab in first-line renal cell carcinoma moved to Completed status on 2026-07-02 with final enrollment of 28 patients, a 60% cut from the 70-patient target set in 2023 and 30% below the original 40-patient target Press ReleasePress ReleaseJul 2, 2026.
- ClinicalTrials.gov shows no posted ORR, PFS, or OS data for either the monotherapy or combination arm, so the trial's completion cannot yet be read as a positive or negative signal on efficacy.
- The registry's own risk model flags this trial at the maximum score of 100 with nine distinct signals, including cumulative primary completion delays of 549 days and three rounds of eligibility criteria changes.
- The trial sits in a landscape scored 'challenging,' with 64 active PD-1 programs in renal cell carcinoma and a 45% Phase 2 failure rate for this target-indication pair, meaning a small, single-country readout carries limited weight against a crowded field.
- Until Akeso discloses ORR data or a filing plan, the enrollment cut itself, not a data readout, is the operative fact for anyone tracking this program.
The registry change
ClinicalTrials.gov recorded two changes to NCT05256472 on 2026-07-02: the trial status moved from Active, not recruiting to Completed, and the enrollment count dropped from 70 to 28 Press ReleasePress ReleaseJul 2, 2026. The trial had already raised its target once, from 40 to 70 patients in September 2023, before the registry recorded the final count at 28, 30% below even that original 40-patient plan. The primary completion date also moved twice, from June 2024 to July 2024 and then out to December 2025, before the trial closed.
Probability of SuccessBased on the AppliedXL Probability of Success model. For more information about the methodology, read the research here.
What the trial measures
The primary endpoint is objective response rate (ORR) per RECIST v1.1, the share of patients whose tumors shrink or disappear, assessed by investigators over up to two years. The design splits into two parts: Part 1 randomized three dosing levels of cadonilimab monotherapy, and Part 2 combined cadonilimab with axitinib, an oral VEGFR inhibitor, in treatment-naive advanced or metastatic disease. This is a Phase 2, open-label, non-randomized study run at sites in China only, and it is explicitly non-registrational, meaning no regulatory submission is directly tied to its result.
The missing data
ClinicalTrials.gov shows no results posted for either primary or secondary endpoints as of this writing. That leaves the enrollment cut as an operational fact without a clinical explanation: the registry does not disclose whether accrual simply ran short, whether a protocol amendment intentionally reduced the target, or whether an interim signal drove an early stop. Akeso's global trial completion rate is 88%, with 59 of 67 tracked programs completed and 8 terminated, which suggests outright termination for cause is not this sponsor's typical pattern.
Landscape and risk
AppliedXL's registry-based risk model scores this trial at the maximum 100 out of 100, citing nine signals: multiple enrollment and completion-date changes, a 30% enrollment shortfall against the original target, and repeated eligibility criteria revisions. The trial also sits in a landscape AppliedXL scores as 'challenging,' with 64 active trials targeting PD-1 in renal cell carcinoma and a 45% failure rate for Phase 2 programs in this target-indication pair, with 19 distinct companies having failed there. The closest direct comparator by mechanism, target, and indication is AstraZeneca's volrustomig, a PD-1-directed bispecific antibody now in Phase 3 for renal cell carcinoma (NCT07000149), which underscores that cadonilimab is not a first-in-class approach in this space.
This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.