OncoMatch/Clinical Trials/NCT04585750
The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)
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)
Is NCT04585750 recruiting? Yes, currently enrolling (Oct 2026). This Phase 1/2 trial studies multiple treatments including rezatapopt and pembrolizumab for advanced solid tumor.
Treatment: rezatapopt · pembrolizumab — The Phase 2 monotherapy portion of this study is currently enrolling and will evaluate the efficacy and safety of PC14586 (INN rezatapopt) in participants with locally advanced or metastatic solid tumors harboring a TP53 Y220C mutation. The Phase 1 portion of the study will assess the safety, tolerability and preliminary efficacy of multiple dose levels of rezatapopt as monotherapy and in Phase 1b in combination with pembrolizumab.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Other
Cancer type
Tumor Agnostic
Non-Small Cell Lung Carcinoma
Small Cell Lung Cancer
Ovarian Cancer
Endometrial Cancer
Prostate Cancer
Colorectal Cancer
Breast Carcinoma
Head and Neck Squamous Cell Carcinoma
Cholangiocarcinoma
Triple-Negative Breast Cancer
Biomarker criteria
Required: TP53 y220c
Locally advanced or metastatic solid malignancy with a TP53 Y220C mutation
Excluded: KRAS mutation
Known KRAS mutation, defined as a single nucleotide variant (SNV) (Phase 2). Exception: Ovarian cancer patients with a known KRAS SNV are permitted.
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Must have received: anticancer therapy
Previously treated with one or more lines of anticancer therapy and progressive disease
Cannot have received: anti-PD-1/PD-L1/PD-L2 or co-inhibitory T-cell receptor therapy
Exception: permitted if not discontinued due to Grade 3 or higher immune-related AE (irAE)
Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor and discontinued from that treatment due to a Grade 3 or higher immune-related AE (irAE)
Cannot have received: rezatapopt
Has previously received rezatapopt
Lab requirements
Blood counts
Kidney function
Liver function
Adequate organ function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of California Irvine Chao Family Comprehensive Cancer Center · Irvine, California
- University of San Diego Moores Cancer Center · La Jolla, California
- UCLA Jonsson Comprehensive Cancer Center · Los Angeles, California
- USC Norris Comprehensive Cancer Center · Los Angeles, California
- Rocky Mountain Cancer Center · Denver, Colorado
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT04585750 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior anti-PD-1/PD-L1/PD-L2 or co-inhibitory T-cell receptor therapy, rezatapopt disqualifies patients from enrollment.
Does this trial require TP53?
Yes, TP53 y220c is a required biomarker for enrollment.
Are patients with KRAS alterations eligible?
No. KRAS mutation is an exclusion criterion.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify