ClinicaliQ Trial Snapshot
- The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE) — Recruiting • Phase I • Oncology • NCT04585750.
- PC14586 (rezatapopt) is being evaluated as a monotherapy in patients with advanced solid tumors carrying the TP53 Y220C mutation, targeting restoration of mutant p53 protein function—a novel approach to a previously undruggable oncogenic mutation.
- Eligible patients have locally advanced or metastatic solid tumors with confirmed TP53 Y220C mutation, representing a genetically-defined patient population selected through precision oncology principles rather than traditional histological classification.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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.
Eligibility Snapshot
- : * At least 18 years of age or 12 to 17 years of age after Safety Review Committee approval. * Locally advanced or metastatic solid malignancy with a TP53 Y220C mutation * Eastern Cooperative Oncology Group (ECOG) status of 0 or 1 * Previously treated with one or more lines of anticancer therapy and progressive disease * Adequate organ function * Measurable disease per RECIST v1.1 (Phase 2) Additional Criteria for Inclusion in Phase 1b (rezatapopt) + pembrolizumab combination) * Anti-PD-1/PD-L1 naive or must have progressed on treatment * Measurable disease
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.