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NCT05720117 (PYX-201 in advanced solid tumor): BVCT ex-ante prediction vs. reported outcome

On 9 Apr 2024, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 20 Nov 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically maybe significant and commercially insufficient (weak efficacy).

Clinical Trial

NCTID
NCT05720117
Drug Name
PYX-201
Drug MoA
anti-fibronectin-EDB ADC with cathepsin B-cleavage mediated release of auristatin payload
Drug Modality
ADC
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
advanced solid tumor
Human Patients
80
Sponsor
Pyxis Oncology
Phase
Phase 1

Prediction of , index 1484

Prospective Prediction
Prediction Index
1484
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit)
Technical Prediction
FAILURE (statistically insignificant clinical benefit in PFS/OS/ORR)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
225 days in advance
Readout Data Interpretation
PYX201 achieved 26% ORR for advanced solid tumors; which is inferior to other targeted therapies for advanced solid tumors; e.g. 56% ORR of Enhertu for HER2+ advanced solid tumors (refer to additional press link for AstraZeneca's data)
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically maybe significant and commercially insufficient (weak efficacy)
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
A First-in-Human, Open-label, Multicenter, Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of PYX-201 in Participants With Advanced Solid Tumors
Phase
Phase 1
Status
Recruiting
Enrollment
330
Lead sponsor
Pyxis Oncology, Inc
Conditions
Solid Tumor; Advanced Solid Tumor
Interventions
DRUG: PYX-201
Design
Non randomized · Parallel · None
Primary purpose
Treatment
Start
2023-03-14
Primary completion
2027-04-25
Completion
2028-06-30
Primary outcomes
  • Number of Participants who Experience a Dose-limiting Toxicity (DLT) in Dose Escalation (Day 1 to Day 21)
  • Safety and Tolerability as assessed by adverse event monitoring for participants in Dose Escalation (Up to approximately 3 years)
  • Objective Response Rate (ORR) observed in participants in Dose Expansion (Up to approximately 2 years)

NCT05720117 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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