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NCT05433142 (XmAb819 in 2L+ advanced clear cell renal cell…): BVCT ex-ante prediction vs. reported outcome

On 13 May 2025, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 24 Oct 2025 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically probably insignificant (non-superior ORR) and commercially TBD.

Clinical Trial

NCTID
NCT05433142
Drug Name
XmAb819
Drug MoA
bispecific antibody that binds both ENPP3 and CD3
Drug Modality
bispecific antibody
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
2L+ advanced clear cell renal cell carcinoma (ccRCC)
Human Patients
95
Sponsor
Xencor
Phase
Phase 1

Prediction of , index 2017

Prospective Prediction
Prediction Index
2017
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit in OS strongly inferior to cabozantinib)
Technical Prediction
FAILURE (statistically insignificant clinical benefit in ORR/PFS compared with placebo with moderate toxicity)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
164 days in advance
Readout Data Interpretation
XmAb819 achieved 20% cORR (4/20) with 1 Grade 4 TEAE (5%); which is non-superior to the SoC cabozantinib that achieved 21% cORR (see add'l link below)
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically probably insignificant (non-superior ORR) and commercially TBD
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
A Phase 1 Multiple Dose Study to Evaluate the Safety and Tolerability of XmAb819 in Subjects With Relapsed or Refractory Clear Cell Renal Cell Carcinoma
Phase
Phase 1
Status
Recruiting
Enrollment
307
Lead sponsor
Xencor, Inc.
Conditions
Clear Cell Renal Cell Carcinoma
Interventions
BIOLOGICAL: XmAb819
Design
Sequential · None
Primary purpose
Treatment
Start
2022-06-13
Primary completion
2027-02
Completion
2028-12
Primary outcomes
  • Incidence of treatment-emergent adverse events (safety and tolerability of XmAb819) (28 days)
  • Incidence of dose limiting toxicities (DLTs) (28 days)

NCT05433142 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials