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NCT04585750 (Rezatapopt in advanced Solid Tumors Harboring a TP53…): BVCT ex-ante prediction vs. reported outcome

On 14 Feb 2025, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 10 Sep 2025 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant (superior ORR) and commercially TBD.

Clinical Trial

NCTID
NCT04585750
Acronym
PYNNACLE
Drug Name
Rezatapopt (PC14586)
Drug MoA
p53 reactivator
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
advanced Solid Tumors Harboring a TP53 Y220C Mutation
Human Patients
300
Sponsor
PMV Pharmaceuticals
Phase
Phase 1 Phase 2

Prediction of , index 1929

Prospective Prediction
Prediction Index
1929
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit as monotherapy in OS non-superior to SoC)
Technical Prediction
partial SUCCESS (statistically significant yet moderate clinical benefit as monotherapy in ORR/PFS compared with placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
208 days in advance
Readout Data Interpretation
Rezatapopt achieved 33% ORR; moderately superior to chemotherapy that achieved 10-20% ORR for advanced solid tumors (see add'l link below); wait for OS data
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant (superior ORR) and commercially TBD
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

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

Official title
A Phase 1/2 Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of PC14586 in Patients With Locally Advanced or Metastatic Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)
Phase
Phase 1, Phase 2
Status
Recruiting
Enrollment
300
Lead sponsor
PMV Pharmaceuticals, Inc
Conditions
Advanced Solid Tumor; Advanced Malignant Neoplasm; Metastatic Cancer; Metastatic Solid Tumor; Lung Cancer; Ovarian Cancer; Endometrial Cancer; Prostate Cancer; Colorectal Cancer; Breast Cancer; Other Cancer; Locally Advanced; Head and Neck Cancer; Gall Bladder Cancer; Small Cell Lung Cancer; Small Cell Lung Cancer ( SCLC ); Small Cell Lung Carcinoma; NSCLC; NSCLC (Non-small Cell Lung Cancer); SCLC; Non-Small Cell Lung Carcinoma; Triple Negative Breast Cancer; TNBC; HER2+ Breast Cancer; Non-Small Cell Lung Cancer; ER/PR Positive Breast Cancer; HER2- Breast Cancer; HER2-positive Breast Cancer; HER2-negative Breast Cancer; ER/PR(+), Her2(-) Breast Cancer
Interventions
DRUG: rezatapopt; DRUG: pembrolizumab
Design
Non randomized · Parallel · None
Primary purpose
Treatment
Start
2020-10-29
Primary completion
2026-12-15
Completion
2027-12-31
Primary outcomes
  • Phase 1 Monotherapy (Dose Escalation): Determine the number and type of adverse events to characterize the safety of rezatapopt (40 months)
  • Phase 1 Monotherapy (Dose Escalation): Establish the Recommended Phase 2 Dose (RP2D) (30 months)
  • Phase 1 Monotherapy (Dose Escalation): Establish the maximum tolerated dose (MTD) (Phase 1) (The first 28 days of treatment (Cycle 1) per patient)
  • Phase 1b Combination Therapy (Part 1: Dose Escalation): Determine the number and type of adverse events to characterize the safety of rezatapopt when administered in combination with pembrolizumab (18 months for treatment arm)
  • Phase 1b Combination Therapy (Part 1: Dose Escalation): Establish the maximum tolerated dose (MTD) of rezatapopt when administered in combination with pembrolizumab (The first 28 days of combination treatment arm (starting on Day -7) per patient)

NCT04585750 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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