The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)
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
No strong warning signs right now. The score counts warning signs; it is not a prediction.
Why this score
No warning signs right now. That's why the score is 0.
Score over time
- Stage
- Phase 1/2
- Patients
- 300 (planned)
- Started
- Oct 29, 2020
- Main results expected
- Dec 15, 2026
- Fully finished
- Dec 31, 2027
- Results posted
- not yet
What counts as success
The trial's main goal(s), called the “primary outcome.”
Phase 1 Monotherapy (Dose Escalation): Determine the number and type of adverse events to characterize the safety of rezatapopt
Measured over: 40 months
Phase 1 Monotherapy (Dose Escalation): Establish the Recommended Phase 2 Dose (RP2D)
Measured over: 30 months
Phase 1 Monotherapy (Dose Escalation): Establish the maximum tolerated dose (MTD) (Phase 1)
Measured over: 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
Measured over: 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
Measured over: The first 28 days of combination treatment arm (starting on Day -7) per patient
Phase 1b Combination Therapy (Part 1: Dose Escalation): Establish the Recommended Phase 2 Dose (RP2D) of rezatapopt when administered in combination with pembrolizumab
Measured over: 18 months
Phase 1b Combination Therapy (Part 2: Dose Expansion): Determine the number and type of adverse events to characterize the safety of rezatapopt when administered in combination with pembrolizumab
Measured over: 12 months for treatment arm
Phase 2 Monotherapy (Dose Expansion): Response rate assessment to evaluate the clinical activity / efficacy of rezatapopt
Measured over: 34 months
Phase 2 Monotherapy (Dose Expansion): Response rate assessment to evaluate the clinical activity / efficacy of rezatapopt in ovarian cancer patients
Measured over: 34 months
Changes Tremor has spotted
Show details (technical version)
Score inputs
- none
Raw record changes
- none yet
Trial ID NCT04585750 · record last updated 2026-10-02 · checked 2026-11-09 15:47 UTC