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NCT04606446 (PF-07248144 Fulvestrant Letrozole Palbociclib… in Locally Advanced or Metastatic ER+ HER2-…): BVCT ex-ante prediction vs. reported outcome

On 15 Jan 2024, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 23 May 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially non-superior to SoC (enhertu).

Clinical Trial

NCTID
NCT04606446
Acronym
KAT6
Drug Name
PF-07248144 Fulvestrant Letrozole Palbociclib PF-07220060
Drug MoA
anti-KAT6A/KAT6B inhibitor
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
Locally Advanced or Metastatic ER+ HER2- Breast Cancer Locally Advanced or Metastatic Castration-resistant Prostate Cancer Locally Advanced or Metastatic Non-small Cell Lung Cancer
Human Patients
186
Sponsor
Pfizer
Phase
Phase 1

Prediction of , index 1420

Prospective Prediction
Prediction Index
1420
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient additive clinical benefit)
Technical Prediction
FAILURE (statistically insignificant additive clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
129 days in advance
Readout Data Interpretation
11.4% ORR (mono 5 prior therapy) and 30.4% ORR (PF07248144 + fulvestrant 1 prior therapy) vs 7-10% fulvestrant (mono) vs 52.3% ORR enhertu destiny-breast04.
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially non-superior to SoC (enhertu)
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
A PHASE 1/2A DOSE ESCALATION AND EXPANSION STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETIC, PHARMACODYNAMIC, AND ANTI-TUMOR ACTIVITY OF PF-07248144 IN PARTICIPANTS WITH ADVANCED OR METASTATIC SOLID TUMORS
Phase
Phase 2
Status
Recruiting
Enrollment
320
Lead sponsor
Pfizer
Conditions
Locally Advanced or Metastatic ER+ HER2- Breast Cancer; Locally Advanced or Metastatic Castration-resistant Prostate Cancer; Locally Advanced or Metastatic Non-small Cell Lung Cancer
Interventions
DRUG: PF-07248144; DRUG: Fulvestrant; DRUG: Letrozole; DRUG: Palbociclib; DRUG: PF-07220060; DRUG: PF-07850327, ARV-471, vepdegestrant
Design
Non randomized · Sequential · None
Primary purpose
Treatment
Start
2020-11-16
Primary completion
2029-07-13
Completion
2029-08-10
Primary outcomes
  • Number of participants with dose-limiting toxicities in the Dose Escalation Arms. (Up to 29 days)
  • Safety and Tolerability as assessed by adverse event monitoring for participants enrolled in the Dose Escalation Arms. (Up to 24 months)
  • Safety and Tolerability through monitoring of laboratory assessments for participants enrolled in the Dose Escalation Arms. (Up to 24 months)
  • Safety and Tolerability as assessed by adverse event monitoring for participants enrolled in the Dose Expansion Arms (Up to 24 months)
  • Safety and Tolerability through monitoring of laboratory assessments for participants enroled in the Dose Expansion Arms (Up to 24 months)

NCT04606446 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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